Clinical and Analytical Performance Studies

Clinical Performance Studies

Qarad organizes clinical performance studies in collaboration with Europe’s most renowned evaluation centers and blood banks. The resulting report, issued by these evaluation centers, will be accepted by your Notified Body. Our service includes all the communication with the evaluation center, drafting evaluation protocols, monitoring the study, data evaluation and writing of the clinical performance study section for your technical documentation of your IVD.

All studies can be designed conform to the applicable standards, like:

  • Common Technical Specifications for Annex II, list A products
  • CLSI standards
  • WHO standards

Our studies will be conducted in line with the draft ISO standard for good study practices (ISO/DIS 20916) and will comply with the national or regional requirements for ethics committee approval.

Analytical Performance Studies

Qarad organizes performance studies to verify the analytical performance of your In Vitro Diagnostics (precision accuracy, sample stability, …) in collaboration with high standard private labs.

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