Centre CAP, located in Montpellier in the south of France, is specialized in the management and the conduct of early phase clinical trials for Biotechnology companies and Pharmaceutical Laboratories.
With an experience of 30 years, its know-how, its human size, and the devotion of its team, Centre CAP has become a site of excellence guaranteeing quality and reliability. Since the beginning of its creation in 1985 Centre CAP has offered personalized services in order to satisfy the most challenging demands. Each client is privileged, receiving a particular attention and a tailored offer. Each trial is unique: we assure a personalized service and study your demand to come up to your expectations in initiating your project and ensuring a fast subjects recruitment.
In compliance with the EMA and FDA regulations and according to GCP and ICH guidelines, Centre CAP has performed several hundreds of studies and has notably conducted all early phase studies on hepatitis C treatment Viraferon PEG, all interaction and dose escalation studies on Viraferon and Ribavirine, and has performed many anti protease and anti polymerase studies on healthy subjects and patients.
Skilled, experienced and regularly trained, Centre CAP staff stands at your sides to carry out your clinical studies face to multiple technical and regulatory constraints. Undergoing internal audits, Centre CAP went through several audits from large Pharmaceutical Companies and each time the excellence of our work has been recognized.
- Early phase expertise, study design, 1st dosing evaluation: Centre CAP places its expertise to your service for your early phase studies, from the design to the 1st dose evaluation
- Full package, from medical writing to study report: besides its ability to bring you advice and strategy in the development of your product, we are able to offer protocol writing, to submit the study files to the competent authorities, and to coordinate dosage, data management, statistics, and study report with our partners.
- Clinical trials conduct: the set-up of a clinical study is rigorously organized with, for each study, the creation of a source document for each subject enabling us to guarantee an optimal data collection.
- Easy and fast recruitment of healthy volunteers and patients: quality of recruitment and safety of subjects is our priority. Our ability to recruit reliable subjects rapidly allows us to always respect the timelines and to offer quality of data. Our collaboration with a network of specialists is a valuable mean for patient recruitment and allows us to take part as a support in recruitment.
- Management of the volunteers’ indemnity: we collect information from the participants of clinical studies with the purpose of disbursing their allowance.
- Administrative department (medical writing, files submissions, study management, recruitment…)
- Facilities dedicated to ambulatory visits
- Hospitalization facilities (external)
- Medical equipments (tensiometer, ECGs, …)
- Private laboratory and pharmacy facilities (refrigerated centrifuges, refrigerators and freezers equipped with temperature sensors and recorders)
- Local lab for all laboratory analyses (external)
- Local archive facilities (external)
- Possibility of contracting with a local data management company
Clinical Trial Audit : for a healthy company , an external audit is an excellent way to enhance your activity. Centre CAP can provide critical information to companies working in Clinical Research who want to evaluate and monitor their organization more closely. Our auditor has a functional expertise necessary to provide an analyze of your organization and elaborate recommendations to correct breaches and weaknesses to strictly comply with regulatory requirements and satisfy your clients and partners.
- Officinal Audit : according to the decree of 28 Nov. 2016 applicable from 1st Feb. 2017 on Good Practice of Drug Dispensation in “chemists”, the auditor of Centre CAP, with id dual competence of pharmacist and qualified auditor offers to analyze your quality system and the general organization of your chemist to make sure that your activity is in compliance with the new regulatory requirements, and with your clients expectancies.
Centre CAP is entitled to the Research Tax Credit, a very effective mechanism for fostering innovation in France
Because being an actor in the progression of one’s business sector is paramount, Dr Rouzier is an active member of Club Phase I, AFCROS and AFSSI.
“L’exigence qualité dans le cadre des essais cliniques est désormais transposable à l’exercice officinal. Mes expériences dans la gestion du médicament et dans l’assurance qualité se rejoignent pour offrir une expertise objective et appliquée.”