Simple therapeutic trial, short patient follow-up, limited study procedures, simple medical history, minimal adverse events and few concomitant treatments.
Complex therapeutic trial with amendment, long patient follow-up, multiple study procedures, complex medical history, numerous adverse events and concomitant treatments, fraud.
Remote verification of the conduct of biomedical research without access to the source file and management of the investigative site between site visits.
Pharmaceutical companies, biotechnology companies, CROs (Clinical Research Organizations) and freelancers.
Professional role play software, reconstituting virtually a monitoring, discrepancy discrimination, justification in relation to regulation and appropriate action plan.
Control of virtual monitoring observations and assignment of targeted video training based on undetected or incorrectly calibrated discrepancies.
Validation of the progress of the CRA by a new, virtually recreated work situation.
Monitoring is a critical, high-risk step for sponsors. Theoretical training in the regulations supporting clinical research must be complemented in response to all issues met in professional situations. Virtual monitoring and Action Site adaptive training aim to individually develop the technical skills of each CRA and bring him up to the required level of excellence.
Errors, falsifications or non-compliance with regulations can invalidate a therapeutic trial supporting a marketing authorisation application.
Initial training: theoretical education ;
Ongoing training: learning of professional skills on
investigator site through monitorings supervised or tutored by a second resource, increasing technical difficulties.
Comprehensive continuing eduction covering all issues in the field;
Solo training within the company ;
Training without calendar constraints;
Training without traveling to the investigator's site and need to provide a double working desk.
The Action Site training programme is open to qualified CRAs with a CRA diploma or professional experience, no minimum field experience and proficient in English.
