The clinical operations are followed with the greatest requirement
On the regulatory perspective ATLANSTAT masters all the new European regulations that apply to clinical trials and clinical investigations:
- The European regulation 2014/536 on clinical trials on medicinal products for human use
- The European regulation 2017/745 on medical devices
- European Regulation 2017/746 on in vitro diagnostic medical devices
- EU General Data Protection Regulation 2016/679 (GDPR)
For studies not covered by one of these texts, we refer to the French Law No 2012-300 of 5 March 2012 on research involving the human person (known as the Jardé Law).
In addition, ATLANSTAT also integrates into its practices the recommendations of international standards, in particular :
- ICH E6 (R2) Good Clinical Practices
- ICH E9 Statistical Principles for Clinical Trials
- VICH GL9 Good Clinical Practices
- ISO 14155:2020: Clinical investigation of medical devices for human subjects
Project monitoring in strict compliance with regulations
The Monitoring team is dedicated to the implementation and follow-up of Phase I to IV or observational studies as well as to any clinical investigation.
ATLANSTAT puts all its experience, its know-how and the capacities of an efficient team at the service of :
- The selection of investigator/expert sites at national or international level
- The implementation of feasibility studiesEvaluation of costs and deadlines
- Drafting of study documents
- Drafting of the protocol
- Preparation and submission of regulatory documents to the competent authorities (ANSM, CPP, CNIL, CNOM) as well as all specificities related to medical devices (including all exchanges with notified bodies)
- Management of experimental products (import, supply, etc.)
- Preparation of and participation in investigator meetings
- Setting up visits to the investigating sites and individualised training for the study participants
- Monitoring throughout the study
- Managing the closure of the sites at the end of the study
- Management of other actors or partners
Testimony of the team
I am a clinical operations project manager and regulatory affairs officer at ATLANSTAT. On a daily basis, I assist our partners, study sponsors, in the set-up, operational implementation and follow-up of their clinical trials.
In this context, my missions are very varied. They include writing synopses, protocols, information notes and informed consents, preparing and submitting Clinical Trial Authorisation applications to the regulatory authorities, carrying out feasibility studies to identify potential investigating centres, managing agreements with the centres, assisting with the deployment of the study in the centres (implementation stages), and supervising the monitoring activities carried out by the CRAs
These activities are carried out in a demanding and constantly evolving regulatory environment, on all types of products (medicines for human use, medical devices, in vitro diagnostic medical devices, etc.), and concern studies on patients as well as on healthy volunteers.
Analytical skills, critical thinking and strong adaptability enable us to respond to the needs of our partners in the best possible way. The diversity of the projects we are entrusted with and the valuable collaboration both internally and externally with other clinical research professions make the position I hold so interesting.