Our services in Clinical Research

1. Regulatory Submissions

Initial regulatory and administrative file: Ethic Committee, ANSM, CCTIRS
Collection of the essential documents
Review and adaptation of the informed consent forms following the French regulation
Submissions of the protocol amendments, of the safety reports and notification of the end of study

2. Lead CRA

Creation/review/adaptation of the study documents: Study Summary, Flow chart, CRF, study drug management, monitoring plan, CRF guideline, newsletters, …
Selection of the Investigators
Management of the logistics of the study
Management and negotiation of financial agreements, “Single contract”
Management of the study budget
Organization and monitoring of the TMF
Training and supervision of ARCs
Review of monitoring reports, follow-up actions
Organization and facilitation of implementation
Coordination with the various departments involved (Project team, Safety, Data Management, Marketing, …)
Management of the inventory of treatments / medical devices under study

3. CRA

Feasibility study
Selection of the Investigators
Pre-study visits
Initiation visits
Visite de Monitoring sur site ou à distance.
Training of the site staff on the study procedures and on GCPs
Monitoring visit on site or remotely
Management of Serious Adverse Events
Investigational Medicinal Product accountability and check of the use and storage conditions
On-site ISF Update / TMF update.
Close out visits.

4. Audits: Preparation of the Investigators sites and CAPA follow-up

Preparation of the Investigators sites to an audit
Help and follow-up of the implementation of corrective and preventive actions according to the “Corrective and Preventive Actions Plan” (CAPA).

5. Study-Coordinator

Receipt, installation and initiation of the study material
Creation of the study procedures for the units involved in the study
Help with patients recruitment
Check of the patients eligibility
Organization and planning of the patient visits, the medical examinations, the biological samples, …, following the study protocol
Update of the patients medical files

Completion of the Case Report Form, queries resolution
Preparation and sending of the ambient and frozen biological samples
Management of the stock of study documents, of the study biological kits and other study material (supply and follow-up of expiry dates)
Management of quality of life, socio-economic or pharmacoeconomic questionnaires.
Report and follow-up of Serious Adverse Events
Interface between the Promotor and the site staff.

6. GCPs Training of the site staff

Geographical area of activity

Our CRAs team is located in 2 regions, in the North and South of France :

We operate throughout France and mainly in the following cities :

France and Overseas

Travel throughout Metropolitan France and the French overseas departments and territories

International

We also operate in Europe and abroad in countries such as Belgium, England, Switzerland, Spain, Germany and Australia.