Restart right, finish right
At Clario we partner with sponsors and Clinical Research Organizations (CROs) to get clinical trials back on track that other endpoint providers have struggled with. Our top priority is to deliver the accurate and compliant endpoint data for successful study completion, with the extra focus and urgency that rescue studies require.
Our senior experts begin by understanding the specifics of each study, then apply their experience across protocol design, therapeutic areas, data and site management, and patient support. Through a collaborative process, specialists architect a scalable solution that considers all patient touchpoints while anticipating and mitigating any future risks.
The Clario difference
Sponsor & CRO Support
Renew the eCOA endpoint solution in your study
From at-risk to rescued: Keep your clinical trial on track
Shadi Zoghi, Clario Vice President for Project Management, discusses some of the competencies that a technology partner should demonstrate during study setup to help ensure a successful launch or relaunch. A qualified endpoint provider offers a range of capabilities including a proven track record, scientific expertise, and project management rigor.
We assign a core team of a project manager, solution design associate, scientific advisor, and technical implementation manager from pre-award through completion.
Clario provides expert staffing, logistics and translations support around the globe.
Senior resources based in Europe, North America, and Asia Pacific provide extended time zone coverage.
Each study is managed with a playbook including a Current State Assessment and Customer Start-up Guidance.
Solutions are adapted to the unique requirements of each study, utilizing proven best practices from prior experiences.
Clario has deep familiarity with the endpoint data standards of governing bodies in different countries.
Our team of scientific experts has relevant experience in therapeutic areas, protocol design, site management, patient support, etc.
Data strategy and diary design are evaluated to recommend the best approach for transitioning eCOA endpoint vendors.
We focus on your success
Our team of scientific and therapeutic experts work closely together on complex, time-critical studies. Our top priority is always delivering the accurate, precise, and compliant endpoint data for sponsors to complete trials successfully.
We have global reach
Clario can support multiple countries and thousands of patients – navigating regulations, shipping and logistics, and more. And our teams are prepared for the changes and fast-moving timelines associated with challenging trials.
We are your trusted partners
We anticipate possible obstacles and address every data, device, and delivery inquiry with customer stakeholders. Count on us for transparent and frequent communications about every dimension of the trial turnaround.
Access resources to help chart the journey to reactivating eCOA endpoint collection in your clinical trial.
What is Clario’s deployment approach to rescue studies?
We recommend a phased rollout to allow flexibility in adapting to experience gained with the initial sites and countries. The specifics of the deployment schedule will need to be planned carefully with the sponsor and/or Clinical Research Organization (CRO).
When should I begin using the new eCOA system?
For a study that is underway with enrolled patients, we recommend that existing patients be switched to the Clario eCOA system at their next scheduled visit after the new system deployment. Clario does not encourage requiring a special visit for the purpose of transitioning to the new system.
How do you manage existing eCOA data?
Clario can use the inbound integration capabilities of our system, specifying our eCOA platform as an integration endpoint, ensuring that the required data is transferred accurately and efficiently. When a patient is initially set up in the Clario eCOA system, the eCOA device (handheld eDiary and/or Tablet) will automatically download the required historical data for that patient to the device.
Should we use a paper COA back up?
Clario discourages sites from using paper backups to the eCOA system. Paper data is patient to increased variability and cannot meet the data defensibility requirements needed for endpoint data in support of a labeling claim. In addition, the use of paper requires documentation of the paper process and documenting training of stakeholders.
Can Clario match our existing reports?
For effective transition to the Clario eCOA system, we assume the sponsor and/or CRO can provide the design specifications for the required reports to Clario.
How do you train on the new solution?
All stakeholders must receive documented training on the Clario eCOA solution. Since the study is already active, it is unlikely that another set of in-person investigator meetings will be held to introduce the replacement eCOA system. Therefore, Clario recommends that site and patient training modules be made available on the eCOA devices themselves. This on-device functionality can be augmented by web-based training.