Presentation

After 7 years at SANOFI-AVENTIS as a CRA specialized in Oncology, then Lead CRA in Cardiovascular, Isabelle GAUDIN founds the Aid’ARC company in 1998.
She was able to gain experience in all stages of a clinical trial: regulatory submissions, financial contracts, creation of study documents (patient informed consent, monitoring plan, CRF, …), organization of Investigators or Experts meetings, Training and management of the CRAs team, all the stages of the monitoring (selection and initiation of the Investigator sites, monitoring, site close-out), GPCs training of the site teams, study-coordination on site, sites preparation for an audit (experience in numerous internal and external audits and ANSM inspections).

A complete experience in Clinical Research, on complex studies, in particular in Oncology-Hematology, Respiratory, Cardiology, Infectiology.
Today, a desire to work closer to the Investigators teams.

And since 2018, an help to the pharmaceutical laboratories and CROs in their quality approach as certified GCP Auditor.

After a 6 months experience as hospital CRA specialized in Cardiology, Jalila joined Aid’ARC.
She has gained extensive experience in the monitoring of the clinical trials (feasibility studies, initiation, monitoring and close-out), in the coordination of the Investigator sites, in regulatory submissions, in financial contracts management and in coordination of CRAs.

Extensive experience in Clinical Research, Expert in clinical trials monitoring, on complex studies, in studies performed in the hospital and in the general medicine, in particular in Cardiology, Oncology-Hematology, Renal transplantation, Infectiology.

After a 6 months experience as CRA in a phase I hospital center, Carole joined Aid’ARC.
She first worked on numerous studies as CRA (feasibility studies, initiation, monitoring and close-out) and as Study-Coordinator, before turning to Lead CRA missions, on international studies with medical devices (Regulatory submissions, review of study documents, creation of tools for CRAs, management of ARCs team, collaboration with the department of Safety, Data Management, Regulatory, Legal …).

A successful experience as CRA and as Lead CRA, particularly on studies with medical devices, numerous regulatory submissions, expertise in Neurology and in Cardiology.