Pre and post marketing clinical studies
Retrospective and prospective clinical studies
The clinical development process is the most crucial step under MDR to provide clinical evidence of effectiveness, safety and life time of your device.
This step can be the longest, least predictable, and most expensive part of developing your product. Eclevar provides cost-effective Clinical Research Organization (CRO) services that can help manufacturer reaching « sufficient clinical data » to provice clinical evidence.
Studies leveraging real world data (RWD) can potentially provide information on a wider patient population, this 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:
• Clinical trials protocols
• Study plan: sample size calculations and power analysis
• Medical Device Data Reporting and Analysis
• Data Monitoring Committee and Destination Management Company (DMC)
• Audit of project management, data management and statistical groups
• Report writing for regulatory approval requests or other reporting requirements