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November 14th, 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 neighboring/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 – Reinstated
  • Proforma Invoice Creation – Reinstated
  • Shipment to Ukraine – Reinstated
  • Shipment from Ukraine – Reinstated

Russia

  • Order Creation – Suspended
  • Proforma Invoice Creation – Suspended
  • Shipment to Russia – Suspended (including resupply)
  • Shipment from Russia – Suspended

Belarus

  • Order Creation – Suspended
  • Proforma Invoice Creation – Suspended
  • Shipments to Belarus – Suspended
  • Shipments from Belarus – Suspended

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 

Clario intends to comply with the intent of the government sanctions imposed. Whilst we are a clinical trial provider and therefore permitted to transact in Russia, many of our products and components remain on the sanction list. To date, our application for exemption of products/components listed on the sanction list has not been approved. Therefore, whilst we are considered a clinical trial provider, we are still unable to legitimately support in-bound and out-bound shipments of such products. Further to this, there are currently no carriers supporting shipments of our products into the affected countries.  

In the event we can ship to Russia, the limited carriers providing services for unsanctioned products are expected to operate with higher than usual fees 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 neighboring 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. 

Re-Supplies

Resupply shipments for both cardiac safety and respiratory components are all suspended as many products/components are included on the sanctions lists, e.g., filters for respiratory devices, electrodes and ECG-paper. Per above, our application to the Federal Office for Economic Affairs and Export Control for exemption has been denied. In summary, whilst we are a clinical trial provider and therefore permitted to transact in Russia, many of our products and components remain on the sanction list, rendering us unable to support resupply shipments at this time. 

We encourage you to always communicate directly with your Project Manager on your trial supply needs and they will support you with what options are available. 

Return Shipments – Ukraine

Returns are potentially possible from Ukraine and we will endeavor to manage returns where feasible. Where there are timeline pressures to close a study, please ensure that you engage with your Project Manager to determine what limitations there may be and what actions need to be taken.

Return Shipments – Russia

Due to the Decree No. 311 of March 09, 2022 of the Government of the Russian Federation, the export of electronic and medical devices from Russia is suspended until at least December 31, 2022. There have been successful return shipments processed whilst this decree has been in place. However, this has been rare, and in each instance, needed to be clarified with the respective study Importer of Record (IOR). The IOR acts as exporter of the equipment and is responsible for preparing all relevant export documents. If successful with their export permit, Clario can assist with the physical transport by leveraging one of our approved couriers.

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. Analysis of transmission data demonstrated significant reductions in transmittals in Ukraine and Russia. The volume of transmissions has remained in this reduced state. 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 enrollment 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 analyzing 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 endeavor 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


July 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 neighboring/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

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 

Clario intends to comply with the intent of the government sanctions imposed. Whilst we are a clinical trial provider and therefore permitted to transact in Russia, many of our products and components remain on the sanction list. To date, our application for exemption of products/components listed on the sanction list has not been approved. Therefore, whilst we are considered a clinical trial provider, we are still unable to legitimately support in-bound and out-bound shipments of such products. Further to this, there are currently no carriers supporting shipments of our products into the affected countries.  

In the event we can ship to Russia, the limited carriers providing services for unsanctioned products are expected to operate with higher than usual fees 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 neighboring 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. 

Re-Supplies

Resupply shipments for both cardiac safety and respiratory components are all suspended as many products/components are included on the sanctions lists, e.g., filters for respiratory devices, electrodes and ECG-paper. Per above, our application to the Federal Office for Economic Affairs and Export Control for exemption has been denied. In summary, whilst we are a clinical trial provider and therefore permitted to transact in Russia, many of our products and components remain on the sanction list, rendering us unable to support resupply shipments at this time. 

We encourage you to always communicate directly with your Project Manager on your trial supply needs and they will support you with what options are available. 

Return Shipments

Return shipments from Russia also remain a challenge. We have been informed that only one carrier is supporting return shipments, making it very difficult and inefficient to coordinate returns. We will endeavor to manage returns where possible through this channel. Where there are timeline pressures to close a study, please ensure that you engage with your Project Manager to determine what limitations there may be and what actions need to be taken.

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. Analysis of transmission data demonstrated significant reductions in transmittals in Ukraine and Russia. The volume of transmissions has remained in this reduced state. 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 enrollment 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 analyzing 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 endeavor 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 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 neighboring/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 analyzing 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 endeavor 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 neighboring/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 enrollment 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 analyzing 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 endeavor 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 enrollment 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 enrollment 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 analyzing 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 wi