Clinical trials management
Clinical trial is a part of medical device and IVD product registration procedure. For 1 risk class medical devices clinical trials should be launched right after obtaining of positive test reports of pre-clinical trials (technical and biocompatibility). For 2a, 2b and 3 risk class devices clinical trials should be launched after obtaining permission for clinical trial from Roszdravnadzor.
Important thing that Roszdravnadzor issues permission for clinical trials without details about human subject, further clinical trials by Russian law could be provided by 2 ways: clinical evaluation without human subject or clinical investigation for human subject. The ability to perform clinical evaluation without human subject instead investigation for human subject depends on professionalism of registration agency.
For all IVD products clinical trials with human samples (blood, urine etc.) is a mandatory requirement.
BeAWire agency provide clinical trials service as a part of registration process.