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May 25th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected. 

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments Devices – Suspended (including resupply)
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Re-Supplies

Resupply shipments for both cardiac safety and respiratory components are all suspended as many products are included on the sanctions lists, e.g., filters for respiratory devices, electrodes and ECG-paper. We have applied to the Federal Office for Economic Affairs and Export Control for exemption and are awaiting their response. 

Exemption Application

In order to ensure compliance of Russia-bound shipments that include materials on the sanction list under Harmonization Tariff Code 8471 such as laptops, smartphones and tablets, a 3-step exemption process completed must be implemented. 

  1. The importer needs to approve the shipment 
  2. The Federal Office for Economic Affairs and Export Control needs to approve the exception permission to ship 
  3. The approval needs to be coordinated with the carrier for transport 

Regarding Medical Devices, we have requested a statement from the Federal Office for Economic Affairs and Export Control to fully understand what approval process is required for shipment to Russia. 

Freight charges for Russian imports are expected to be higher than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain. Additionally, whilst we have seen carrier cost fluctuations in neighbouring countries such as Georgia, no further impacts have been identified. 

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy. 

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted. 

We had previously reported decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. Following analysis of transmission data, we have observed a 47% decline in transmittals in Ukraine and a 17% decline in Russia. Whilst there is speculation on Russia’s withdrawal from the global internet, there has yet to be any confirmation on what access there may or may not be for outside countries. We are closely monitoring this and will develop appropriate mitigations where possible as the visibility of the situation improves. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support. 

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk. 

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country on your trials, Clario can support this through our current change management practices, and we ask that you communicate with us early-on any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials. 

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed. 

Updated sanction lists have included names of individuals who may be working at hospital/research institutes in Russia. Our response team is currently cross-referencing this list against all site contacts in Russia. Should we identify any contacts on this list involved in any of your studies, our Project Management team will contact you to determine the best course of action. We will continue to monitor any further sanctions of this nature and advise you accordingly. 

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


May 13th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected. 

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments Devices – Suspended (including resupply)
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Re-Supplies

Resupply shipments for both cardiac safety and respiratory components are all suspended as many products are included on the sanctions lists, e.g., filters for respiratory devices, electrodes and ECG-paper. We have applied to the Federal Office for Economic Affairs and Export Control for exemption and are expecting a response by the 20th of May. 

Exemption Application

In order to ensure compliance of Russia-bound shipments that include materials on the sanction list under Harmonization Tariff Code 8471 such as laptops, smartphones and tablets, a 3-step exemption process completed must be implemented. 

  1. The importer needs to approve the shipment 
  2. The Federal Office for Economic Affairs and Export Control needs to approve the exception permission to ship 
  3. The approval needs to be coordinated with the carrier for transport 

Regarding Medical Devices, we have requested a statement from the Federal Office for Economic Affairs and Export Control to fully understand what approval process is required for shipment to Russia. 

Freight charges for Russian imports are expected to be higher than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain. Additionally, whilst we have seen carrier cost fluctuations in neighbouring countries such as Georgia, no further impacts have been identified. 

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy. 

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted. 

We had previously reported decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. Following analysis of transmission data, we have observed a 47% decline in transmittals in Ukraine and a 17% decline in Russia. Whilst there is speculation on Russia’s withdrawal from the global internet, there has yet to be any confirmation on what access there may or may not be for outside countries. We are closely monitoring this and will develop appropriate mitigations where possible as the visibility of the situation improves. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support. 

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk. 

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country on your trials, Clario can support this through our current change management practices, and we ask that you communicate with us early-on any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials. 

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed. 

Updated sanction lists have included names of individuals who may be working at hospital/research institutes in Russia. Our response team is currently cross-referencing this list against all site contacts in Russia. Should we identify any contacts on this list involved in any of your studies, our Project Management team will contact you to determine the best course of action. We will continue to monitor any further sanctions of this nature and advise you accordingly. 

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


April 13th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected. 

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments Devices – Currently not possible (under review by the Federal Office for Economic Affairs and Export Control)
  • Inbound Shipments Re-Supplies* – Currently only possible for Cardiac Safety
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

*Re-Supplies

  • Respiratory (pulmonary testing): Accessories used for clinical trials, including bacterial filters for respiratory devices, ink cartridges and other products are on the sanctions list, which means Clario cannot ship until further notice. The Federal Office for Economic Affairs and Export Control did not give permission to export electronics and filters. Our application for exemption is pending approval.

  • Cardiac Safety: Electrodes, ECG-paper and related items were successfully shipped in the last 2 weeks. For existing protocols, Clario will continue to ship re-supply orders for items which are not on the sanction list.  

Following the receipt of guidance from the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. However, in order to ensure the compliance of Russia-bound shipments that include materials on the sanction list under Harmonization tariff code 8471, such as laptops, smartphones and tablets, a 3-step exemption process must be completed: 

  1. The importer needs to approve the shipment. 
  2. The Federal Office for Economic Affairs and Export Control needs to approve the exception permission to ship. 
  3. This approval needs to be coordinated with the carrier for transport. 

Regarding medical devices, we have requested a statement from the Federal Office for Economic Affairs and Export Control to fully understand what approval process is required for shipment to Russia. 

Freight charges for Russian imports are expected to be more expensive than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain. Additionally, whilst we have seen carrier cost fluctuations in neighbouring countries such as Georgia, no further impacts have been identified. 

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy. 

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted. 

We had previously reported decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. Following analysis of transmission data, we have observed a 47% decline in transmittals in Ukraine and a 17% decline in Russia. Whilst there is speculation on Russia’s withdrawal from the global internet, there has yet to be any confirmation on what access there may or may not be for outside countries. We are closely monitoring this and will develop appropriate mitigations where possible as the visibility of the situation improves. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support. 

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk. 

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that Sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country on your trials, Clario can support this through our current change management practices and we ask that you communicate with us early on any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Updated sanction lists have included names of individuals who may be working at hospital/research institutes in Russia. Our response team is currently reviewing this list against all site contacts in Russia. Should we identify any contacts on this list involved in any of your studies our Project Management team will contact you to determine the appropriate steps to be taken. We will continue to monitor any further sanctions of this nature and advise you accordingly.

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


April 4th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected. 

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments – Test shipments into Russia are in progress
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Following the receipt of guidance from the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. However, in order to ensure the compliance of Russia-bound shipments that include materials on the sanction list under Harmonization tariff code 8471, such as laptops, smartphones and tablets, a 3-step exemption process must be completed: 

  1. The importer needs to approve the shipment. 
  2. The Federal Office for Economic Affairs and Export Control needs to approve the exception permission to ship. 
  3. This approval needs to be coordinated with the carrier for transport. 

Regarding medical devices, we have requested a statement from the Federal Office for Economic Affairs and Export Control to fully understand what approval process is required for shipment to Russia. 

Freight charges for Russian imports are expected to be more expensive than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain. Additionally, whilst we have seen carrier cost fluctuations in neighbouring countries such as Georgia, no further impacts have been identified. 

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy. 

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted. 

We had previously reported decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. Following analysis of transmission data, we have observed a 47% decline in transmittals in Ukraine and a 17% decline in Russia. Whilst there is speculation on Russia’s withdrawal from the global internet, there has yet to be any confirmation on what access there may or may not be for outside countries. We are closely monitoring this and will develop appropriate mitigations where possible as the visibility of the situation improves. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support. 

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk. 

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that Sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country on your trials, Clario can support this through our current change management practices and we ask that you communicate with us early on any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Updated sanction lists have included names of individuals who may be working at hospital/research institutes in Russia. Our response team is currently reviewing this list against all site contacts in Russia. Should we identify any contacts on this list involved in any of your studies our Project Management team will contact you to determine the appropriate steps to be taken. We will continue to monitor any further sanctions of this nature and advise you accordingly.

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 29th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected.

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments – Test shipments into Russia are in progress
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

According to the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. We still exploring supply chain routes that can safely enable your clinical trial supplies to be shipped to sites in Russia. We currently have shipments in process and we are prepared to react to any challenges we may face during transit. We will proceed with caution and closely monitor these shipments to ensure they clear customs before we can be confident about supply chain continuity and we will share our experience and capabilities post completion.

Freight charges for Russian imports are expected to be more expensive than usual at this time. We have little advance notice of price increases and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain.

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted.

We had previously reported decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. Following analysis of transmission data, we have observed a 47% decline in transmittals in Ukraine and 17% decline in Russia. Whilst there is speculation on Russia’s withdrawal from the global internet, there has yet to be any confirmation on what access there may or may not be for outside countries. We are closely monitoring this and will develop appropriate mitigations where possible as the visibility of the situation improves. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients. We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that Sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country on your trials, Clario can support this through our current change management practices and we ask that you communicate with us early on any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Updated sanction lists have included names of individuals who may be working at hospital/research institutes in Russia. Our response team is currently reviewing this list against all site contacts in Russia. Should we identify any contacts on this list involved in any of your studies our Project Management team will contact you to determine the appropriate steps to be taken. We will continue to monitor any further sanctions of this nature and advise you accordingly.

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 22nd, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected.

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments – Test shipments into Russia are in progress
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Following the receipt of guidance from the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. We are still exploring supply chain routes that can safely enable your clinical trial supplies to be shipped to sites in Russia. We currently have shipments in-process and we are prepared to react to any challenges we may face during transit. We will proceed with caution and closely monitor these shipments to ensure they clear customs before we can be confident about supply chain continuity. We will share our experience and capabilities post-completion.

Freight charges for Russian imports are expected to be more expensive than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain.

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted.

Currently, we see decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients. We have established internal triage groups across our product lines to enable our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trial Continuity 

Given that many of our customers have had to freeze enrolment within the affected countries, we do expect that Sponsors will look to other countries to make up the required patient populations necessary for their protocol. Doing this through active countries on the trial will be the most efficient solution. However, if you decide to open a new country in your trial, Clario can support you through our current change management practices. We ask that you communicate with us early on regarding any potential strategies you are considering so that we can proactively advise on solutions and any experiences we are seeing across other active trials.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. With the exemption of clinical trial materials being supported by regulations, we anticipate that customs services for our shipments will resume in Russia. We will closely manage the first few shipments to understand if there are additional difficulties to overcome. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Cyber Security

Our Cyber Security operations team fully aligns to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective and no concerns relating to our services and infrastructure have materialized.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications is monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 18th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected.

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Possible with risk of delay
  • Inbound Shipments – Test shipments into Russia are in progress
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Following the receipt of guidance from the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. We are currently exploring supply chain routes that can safely enable your clinical trial supplies to be shipped to sites in Russia with initial shipments planned for March 18th, 2022. We will proceed with caution and closely monitor these shipments to ensure they clear customs before we can be confident about supply chain continuity.

Freight charges for Russian imports are expected to be higher than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain.

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted.

Currently, we see decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks, and insurance companies to ensure that we meet trade and financial compliance requirements. The sanctions would ordinarily result in difficulties arising with customs payments. However, these activities are currently suspended for Russia. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Cyber Security

Our Cyber Security operations team is fully enabled to align to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective with no concerns relating to our services and infrastructure materializing.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications are monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 15th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected.

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Delayed but will resume March 16th, 2022
  • Inbound Shipments – Test shipments planned for March 17th, 2022
  • Outbound Shipments – Under assessment

Belarus

  • Order Creation – Administration suspended
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Following the receipt of guidance from the European Council, EU 2022/328, Clinical Trial Supplies are exempt from the trade sanctions. We are currently exploring supply chain routes that can enable the safe shipment of your clinical trial supplies to sites in Russia, with initial shipments planned for March 17th, 2022. We will proceed with caution and closely monitor these shipments to ensure they clear customs before being confident about supply chain continuity.

Freight charges for Russian imports are expected to be more expensive than usual at this time. We have little advance notice of this and ask for your patience and understanding as our carriers attempt to regain continuity of the supply chain.

Our carriers continue to alert us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible to manage your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted. 

Currently, we see decreased telecoms activity from within Ukraine, indicating less study level activity, due either to disruption to in-country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and inform us how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations or alternative data collection methods. Please reach out to your Clario Project Manager if you need consultative support.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks, and insurance companies to ensure that we meet trade and financial compliance requirements. The sanctions would ordinarily result in difficulties arising with customs payments. However, these activities are currently suspended for Russia. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Cyber Security

Our Cyber Security operations team is fully enabled to align to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective with no concerns relating to our services and infrastructure materializing.

1 Identify and catalogue ALL internet exposed assets.

  • Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal.
  • Infrastructure for all internet-facing clinical applications are monitored 24x7x365 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.

  • Our continuous 24x7x365 network and server endpoint monitoring system captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team identifies and evaluates risks and develops and executes appropriate remediation steps.
  • As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.

  • Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.
  • For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.

  • This is the primary function of the Clario SOC.  

Next Steps: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation to which our critical response team will continue to observe and respond. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication. Meanwhile, should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 11th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the following updates. Because the situation is evolving so rapidly, we encourage you to engage directly with your Clario Project Manager to understand how your studies in Ukraine and neighbouring/impacted regions may be affected.

Logistics 

We continue to monitor the impact to supply chain continuity within the affected countries. Below is an updated summary of import/export capabilities across the impacted countries.

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Possible at risk
  • Outbound Shipments – Possible at risk

All courier partners have suspended services in Russia and Ukraine. Only one carrier remains active in Belarus and is utilizes road import/export only. Consequently, depending on the demand level to/from Belarus, we expect shipment delays and cost implications based on the prioritization of transits. Further, as we have seen capabilities continue to be restricted, we expect that there will soon be no access to Belarus.

Our carriers are now alerting us of the potential for delays in transit to the APAC region. As of today, we have not yet observed any significant impacts but will continue to monitor the situation. Our Project Management team will share visibility at the study level and work with you as best possible in managing your shipments. We encourage you to proactively engage with your Clario Project Manager to prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our Project Management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established, at which point it will be transmitted.

Currently, we see decreased telecoms activity from within Ukraine, indicating less study level activity, either due to disruption to in-country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients.

We have established internal triage groups across our product lines to allow our Project Managers to get quick assessments on technical options/feasibility of any requests you may have. These groups are already proactively identifying methods to best support client requests regarding limitations on shipping capabilities, patient site migrations, alternative data collection methods, etc. Please reach out to your Clario Project Manager if you need consultative support.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is a heightened risk that devices may not be running on the latest software release. Therefore, any patient using offline capabilities may be using an old version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks, and insurance companies to ensure that we meet trade and financial compliance requirements. The sanctions would ordinarily result in difficulties arising with customs payments. However, these activities are currently suspended for Russia. As more information is provided regarding sanctions and financial consequences with affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Cyber Security

Our Cyber Security operations team is fully enabled to align to US Cybersecurity and infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture. To date, this program has been effective with no concerns relating to our services and infrastructure materializing.

1 Identify and catalogue ALL internet exposed assets.
Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network – whether external or internal. For all internet-facing clinical applications, the infrastructure and applications are being monitored 24×7 by Clario’s security platform and Security Operations Centre (SOC). The SOC is receiving weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.
Our continuous 24x7x365 network and server endpoint monitoring captures all security events in a Security and Event Monitoring (SIEM) platform. From this system, our security operations team leads the identification and evaluation of risks and develops and executes appropriate remediation steps. As a result of the crisis in Ukraine, the Clario SOC has applied a heightened focus on cybersecurity events/intrusions. Our Security Operations Team generates and reviews daily reports on these events/intrusions, particularly those sourced from Russian IP address space.

3 Protect ALL cloud-based services.
Clario provides continuous Security Impact Assessments for all internet-facing applications, applying remediation where necessary.

For all endpoints, user laptops, workstations and servers integrated with cloud-based services, Clario continuously monitors infrastructure and captures security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.
This is the primary function of the Clario’s SOC.

What we do next: 

Our Project Management team is fully aware of all active studies impacted by the current events and will coordinate with you on recommended actions. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation that our critical response team will continue to observe and respond to. It is important that we remain fully aligned with our clients, so we will endeavour to maintain the appropriate level of outbound communication, but should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 8th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the below updates. Please note that events and subsequent impacts are changing regularly and as such we encourage you to engage with your Clario Project Manager for the most recent understanding of impacts to your studies supporting Ukraine and neighbouring/impacted regions.

Logistics 

We continue to monitor the impact to supply chain continuity in the affected countries. Below is an updated summary of import/export capabilities across impacted countries:

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Operating
  • Inbound Shipments – Possibly at risk
  • Outbound Shipments – Possibly at risk

All courier partners have suspended services in Russia and Ukraine. In Belarus, only one carrier remains active and is utilizing road import/export only. Consequently, depending on the demand level to/from Belarus, shipment delays and potential cost implications are expected should there be prioritization on transits. As we have seen capabilities continue to be restricted, it is expected that soon there will be no access to Belarus.

50% of our carriers are now reporting delays in transit to the APAC region. Our Project Management team will support you with visibility at the study level and work with you in managing your shipments to the best of our abilities.

We encourage you to engage with your Clario Project Manager to proactively prepare and manage impacts or potential changes to your trial strategy.

Data Transmission & Trial Management 

Internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our service lines, our project management teams will support you with operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities, enabling data to be stored on devices until an internet connection is established, at which point the data will be transmitted.

Currently, we are seeing decreased telecoms activity from within Ukraine, indicating less study level activity is taking place, either through disruption to in-country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and inform us how you intend to manage affected patients. We have established internal triage groups across our product lines to allow our Project Managers to quickly assess technical options/feasibility of any requests you may have.

Any study with ongoing changes to software for devices in the field will be impacted if there is no access to the internet. Consequently, if your study includes Ukraine, there is heightened risk that a software release may not become effective. Therefore, any patient using offline capabilities could continue to use an old software version in error. Should your study have ongoing updates, your Project Manager will discuss this with you so that we can collectively monitor active sites/patients to mitigate this risk.

Trade Compliance 

We are continuously analysing this situation in terms of regulations and are cooperating with our partners, banks and insurance companies to ensure that we meet trade and financial compliance requirements. The sanctions in place would ordinarily result in difficulties arising with customs payments. However, these activities are currently suspended for Russia. As more information is provided regarding sanctions and subsequent financial consequences for affected banks, we will evaluate our position relevant to clinical trial management and proactively engage with you where needed.

Cyber Security

Our Cyber Security operations team is fully enabled to align to US Cybersecurity and Infrastructure Security Agency (CISA) recommendations, including a “Shields Up” program that recommends four steps to strengthen security posture:

1 Identify and catalogue ALL internet exposed assets.
Clario maintains applications service catalogues that identify clinical and business operations, who can access the applications and how they are connected on the network, whether external or internal. For all internet-facing clinical applications, the infrastructure and applications are being monitored 24×7 by Clario’s security platform and Security Operations Centre (SOC). The SOC receives weekly threat intelligence reports from our security partner, Mandiant Managed Defence.

2 Detect, prioritize, and remediate known exploitable vulnerabilities.
Our continuous (24x7x365) network and server endpoint monitoring system captures all security events in a security and event monitoring (SIEM) platform. Our security operations team leads the identification and evaluation of risks to develop and execute appropriate remediation steps from this platform. As a result of the crisis in Ukraine, the Clario Security Operations Centre has applied heightened focus on cybersecurity events/intrusions specifically sourced from Russian IP address space. A daily report is generated and reviewed by the Security Operations Team.

3 Protect ALL cloud-based services.
For Clario’s internet-facing corporate applications, security assessments are continuously at work, allowing Security Impact Assessments to take place and, if necessary, remediations are put in place. All endpoints, user laptops, workstations, and servers integrated with cloud-based services continuously monitor infrastructure and capture security events in a SIEM platform.

4 Continuously alert, triage and remediate on detected intrusions.
This is the primary function of the Clario’s Security Operations Centre.

What we do next: 

Our Project Management Team is fully aware of all active studies impacted by the current events and will coordinate with you on any actions that we believe should be taken at this time. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

Our critical response team will continue to observe and react to this evolving situation. It is important to us that we remain fully aligned with our clients. We will endeavour to maintain the appropriate level of communication with you during this time, but should you have any questions, please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


March 02nd, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the below updates. Please note that events and subsequent impacts are changing regularly and as such we encourage you to engage with your Clario Project Manager for the most recent understanding of impacts to your studies supporting Ukraine and neighbouring/impacted regions.

Logistics 

As a result of the growing conflict, we are monitoring impacts to neighbouring flights paths as well as the access to the immediate affected countries. Below is the current summary of import/export capabilities across impacted countries:

Ukraine

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Russia

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Suspended
  • Inbound Shipments – Suspended
  • Outbound Shipments – Suspended

Belarus

  • Order Creation – Administration possible
  • Proforma Invoice Creation – Operating
  • Inbound Shipments – Possible with Risk to timelines
  • Outbound Shipments – Possible with Risk to timelines

All courier partners have suspended services supporting Russia, Ukraine and Belarus, with the exception of two providers, who are still attempting to process imports and exports to/from Belarus. Consequently, depending on the demand level to/from Belarus it is expected that there will be delays with shipments and potential cost implications should there be prioritization on transits. Given that the majority of our partners are unable to ship to Belarus we are expecting a similar update from the remaining couriers in the near future.

Continuity of flight paths to other neighbouring regions currently remain unaffected, and we will continue to monitor this as the situation continues.

Data Transmission & Trial Management 

It is expected that internet and telecommunication services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our services lines, our project management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established at which point it will be transmitted.

At this time, we are seeing decreased telecoms activity from within Ukraine, indicating less study level activity is taking place, either through disruption to in country telecoms services or from patients being unable to complete their assessments. We encourage you to engage with your Clario Project Manager and keep us informed on how you intend to manage affected patients. We are setting up internal triage groups across our product lines to allow our Project Managers to get quick assessment on technical options/feasibility of any requests you may have.

Trade Compliance 

We are continuously analysing this situation with respect to regulations and are cooperating with our partners, banks, and insurance companies to ensure that we meet trade and financial compliance requirements. As more information is provided regarding sanctions and subsequent financial consequences for affected banks, we will be able to proactively engage with you in the event that your trial(s) is/are impacted.

What we do next: 

Our Project Management Team is fully aware of any active studies impacted by the current events and will coordinate with you on any actions that we feel need taken at this time. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients.

This is an evolving situation that our critical response team will continue to observe and react to. It is important to us that we remain fully aligned to our clients. We will endeavour to maintain the appropriate level of communication with you during this time but should you have any questions please do not hesitate to contact your Project Manager.

Kind Regards,
Clario Executive Leadership


February 28th, 2022

Dear Client, 

Further to the ongoing events unfolding in Ukraine and the subsequent impacts of the conflict, we would like to provide you with the below updates. Please note that events and subsequent impacts are changing regularly and as such we encourage you to engage with your Clario Project Manager for the most recent understanding of impacts to your studies supporting Ukraine and neighbouring/impacted regions.

Logistics 

Our courier partners supporting the region have continued to advise that custom services are not operational, and borders are closed. Therefore, all in country shipments and all inbound and outbound services from airports remain suspended. All shipments in-transit will be held at the respective hub locations and can be monitored with the associated tracking information. To prevent any further impact to your inventory we have suspended processing of all Ukraine inbound & outbound shipments. 

Today our courier partners advised that they are unable to enter Russian airspace. As a result, all inbound and outbound shipments from Russia are suspended. It is expected that we will receive further updates on this position by the 02nd March 2022, at which point we will advise you accordingly. The closure of Russian airspace may also have an impact on long haul flight paths to the APAC region. We are closely monitoring availability and will advise you of any impacts. It is however expected that should there be disruption to flight paths and capacity is limited, courier timeline and costs will likely be negatively impacted. Our logistics team are monitoring this closely and will attempt to proactively inform you as best we can.

Data Transmission & Trial Management 

It is expected that internet services may be subject to disruption during this crisis. However, Clario’s ability to receive and process data remains intact. Across all our services lines, our project management teams will support you through operational strategies in the event of temporary or permanent loss of connectivity. Additionally, our eCOA platform operates with offline capabilities enabling data to be stored on devices until an internet connection is established at which point it will be transmitted. We also understand that you may wish to relocate patients to sites in neighbouring countries. If you do wish to consider this approach, please engage with your Clario Project Manager to evaluate this option.

Trade Compliance 

With sanctions being imposed on the Russian financial system, there may be consequences for services leveraging Russian banks and associated payment systems. Our Legal and Finance teams are continuing to monitor any directions provided and we will update you and our team accordingly should there be any impacts to our service continuity in the affected regions. Currently, shipments to the Donbas Region are physically not possible. However, any shipments to this region are only allowed following express permission/license approval from the US Department of Commerce. 

With updates expected this week on which banks sanctions will be imposed upon, Clario will then be able to understand at a project level which studies could be impacted. Whilst the sanctions may impact Clario’s ability to make payments to Russian banks, it is anticipated that Russia’s response will be to ban reciprocal payments. When we have a robust view on trade compliance our Project Management Team will liaise directly with their client counterparts to collaborate on the study level responses.

What we do next: 

Our Project Management Team is fully aware of any active studies impacted by the current events and will coordinate with you on any actions that we feel need taken at this time. We encourage you to collaborate closely with your Clario Project Manager and support team to ensure that we are aligned on how you wish to manage your patients. 

This is an evolving situation that our critical response team will continue to observe and react to. It is important to us that we remain fully aligned to our clients. We will endeavour to maintain the appropriate level of communication with you during this time but should you have any questions please do not hesitate to contact your Project Manager. 

Kind Regards,
Clario Executive Leadership