Clinical trials

The Moscow Center for Diagnostics & Telemedicine is certified by the Moscow Health Care Department to conduct clinical trials as per the Unified Register of Organizations Authorized to Conduct Trials (Testing) of Medical Devices for the Purpose of their Registration on the Territory of the EAEU, the Roszdravnadzor Register of Medical Organizations Conducting Clinical Trials of Medical Devices, the legislation of the Russian Federation, international documents, the Charter and the Policy on Clinical Trials.

Please send an application in  arbitrary form and your questions to ctmd@zdrav.mos.ru

 

Our advantages
01.

Expertise accumulated during the Computer Vision Moscow Experiment

 

02.

The Center develops regulatory technical documents related to “Artificial Intelligence in Healthcare” (a series of national standards)

03.

The Computer Vision Moscow Experiment aggregated and tested the reference data sets

04.

The Clinical Trials Sector operates on the basis of the Center

05.

A methodology of clinical trials was developed and tested in line with the draft national standard for clinical assessment

Goal of clinical trials

compliance assessment of a medical device to obtain a Marketing Authorization from Roszdravnadzor based on the GCP principles

Test object

software as a medical device

The intent of clinical trials

is to study the functional properties, efficiency and safety of a medical device in accordance with its use case scenarios as specified in the manufacturer's documentation

Clinical trials are conducted

by analysing and evaluating data in accordance with the program of clinical trials