Reporting

Clinical Performance Evaluation Report is one of the most important documents related to a medical device. It is a scientific document that includes detailed information on the methods applied and trial results. The performance evaluation report proves the efficacy and safety of a medical device.

It includes key parameters of a device and results obtained by target users. The quality of the report should reflect the high standard of the trial completed. Following Good Clinical Practice principles, ISO 145155 and ISO 20916, a comprehensive document should be drafted, presenting the project assumptions, subject inclusion and exclusion criteria, statistical analysis and results.

With support from Pure Clinical, trial reports are complete and consistent documents in line with the applicable guidelines. We focus on the highest quality of our documentation.

Q&A:

What is CPSR?

CPSR stands for Clinical Performance Study Report. This is a document containing a report on the performance evaluation and all appendices. This document summarizes all assumptions, course, statistical analysis, as well as a summary of performance evaluation.

What is an endpoint?

Endpoints of the performance evaluation are important events significant for the trial subject or tested material. The index used in clinical efficacy trials completed as part of performance evaluation of a medical device for IVD may be an example of an endpoint with regards to the in vitro diagnostic medical device.

What does EC mean?

EC stands for Ethics Committee. This is an independent institution whose task is to review and verify the trial design in order to protect the rights, safety and well-being of subjects participating in the trial.