Clinical Trials

Clinical Evaluation Report

CLINICAL TRIALS SITES

Real-World Evidence Generation

Network Models

A Rigorous Site Qualification Process 

Ensuring High-Quality Study Delivery

Digital PMCF

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Alexandre Templier presenting our healthcare solution with Sanofi during Vivatech conference

Clinical Trials (Sufficient Clinical Data)

  • Do you need to conduct clinical investigations to provide sufficient clinical data about the safety and performance of your device?

  • Are you looking to leverage real-world data (RWD) in order to support the lifetime of your device?

  • Are you looking for premarket clinical trials network sites?

You are in the right place. Our global premarket and postmarket clinical development network makes us the most effective CRO to conduct clinical trials.

More rigorous clinical evidence for Class III and implantable medical devices:

Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical data to support the claims on both safety and performance.

ECLEVAR can support:

  • Premarket clinical trials
  • Postmarket clinical trials
  • Real-World data (RWD)

Studies leveraging Real-World Data (RWD) can potentially provide information on a wider patient population, thus providing information that cannot be obtained through a traditional clinical trial alone.

Therefore, to prevent potential bias, careful study design is needed, and a study protocol and analysis plan should be created prior to accessing, retrieving, and analyzing RWD, regardless of whether the RWD are already collected (retrospective) or they are to be collected in the future (prospective design).

To meet MDR requirements, device manufacturers should design and run PMCF studies with three major goals:

  • Confirming device safety and clinical performance
  • Ensuring continued acceptability of identified risks
  • Detecting emerging risks on the basis of factual evidence