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Comprehensive training aimed at developing the operational skills of junior and senior Clinical Research Associates (CRAs). Throughout their training course, CRAs are put into work situations recreated in a virtual environment.
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 laboratories, biotechnology companies, CROs (biomedical research service companies) and self-employed workers.
Software that puts you in a professional situation, virtually reconstituting a monitoring exercise, discriminating against discrepancies, justifying them in relation to legislation and drawing up an appropriate action plan.
Control of virtual monitoring observations and assignment of targeted video training based on undetected or incorrectly calibrated discrepancies.
The CRA's progress is validated by a new, virtually recreated work situation.
Monitoring is a critical, high-risk stage for sponsors. Theoretical training in the regulations underpinning clinical research must be supplemented in the face of the many problems encountered in professional situations. Virtual monitoring and Action Site adaptive training aim to develop the technical skills of each CRA individually and bring them up to the required level of excellence.
Errors, falsifications or non-compliance with regulations can invalidate a therapeutic trial in support of a marketing authorisation application.
Initial training: theoretical instruction ;
Ongoing training: learning professional skills on the investigator site through monitoring supervised or tutored by a second resource, increasing technical difficulties.
Comprehensive in-service training covering all issues in the field;
Solo training within the company ;
Training without calendar constraints;
Training without having to travel to the investigator's site and the need to provide a double workspace.
The Action Site training programme is open to qualified CRAs who hold a CRA diploma or professional qualification, with no minimum field experience.
