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
  • Training of Investigators and Study-Coordinators in Good Clinical Practice.

Aid’ARC has been providing services in Clinical Research for 20 years

Geographical area of activity

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

  • North : in Normandy, near PARIS
  •  South : in the South-West, near TOULOUSE

We operate throughout France and mainly in the following cities :

  • PARIS et Région Parisienne
  • Lille
  • Rouen
  • Caen
  • Rennes
  • Brest
  • Nantes
  • Angers
  • Tours
  • Poitiers
  • Limoges
  • Toulouse
  • Albi
  • Pau
  • Tarbes
  • Bordeaux
  • Périgueux
  • Montpellier
  • Nîmes
  • Marseille
  • Toulon
  • Lyon
  • Grenoble
  • Nice
  • Clermont-Ferrand
  • Strasbourg
  • Nancy
France and Overseas

Travel throughout Metropolitan France and the French overseas departments and territories


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