In a clinical trial, the verification of the data entered by the investigative centres is a very important step which can now be partly carried out remotely. The mission of the Clinical Research Associate (CRA) is to regularly visit the trial investigator sites to verify the CRFs and control source data, issue correction requests, manage safety and pharmacovigilance data and ensure that the site’s recruitment activity be in accordance with the initial commitments.
The use of electronic CRF (eCRF) is old and tends to become widespread in recent years. On the other hand, remote monitoring (or off-site monitoring), which combines the use of NICT (New Information and Communication Technologies) with the art of monitoring, is an innovative means that changes CRA’s profession and which only got bigger recently with the Covid19 crisis.
Remote data review thus improves the efficiency of the process by allowing the CRA, during fewer site visits, to devote more time to other important tasks such as training, support and motivation of study staff, review and collection of essential documents relating to the monitoring of adverse events.
Remote monitoring allows you to have remote contact with the investigator (videoconference) and to share medical documents in a secure space to compare them with CRF data remotely. These new procedures, which were accepted urgently during the Covid19 crisis by European and French agencies, will most likely continue in the future and become part of our habits for clinical research. It will be necessary to ensure all the necessary security measures (encrypted connections, data encrypted and securely hosted, strong user authentication protocols, etc.).
As a player engaged in the field of digital health for 8 years and to meet these regulatory obligations, InAdvans has developed the “telem2pro” solution, a modular platform that can be configured to the specificities of the study protocol allowing remote monitoring to be carried out by integrating a secure videoconferencing module and a medical parts depot. This application makes it possible to envisage faster, simpler, more secure, and more efficient monitoring.
For more information: firstname.lastname@example.org