Full support and care
Clinical trials
Study design
Writing the protocol
Site selection
Regulatory submissions
Implementation
Follow-up to the study
Data analysis
Our clinical strategy
Centaur Clinical CRO has a team of experts in clinical operations and regulatory affairs, who can assist the DM/DIV manufacturer from the design of the clinical trial through to the compilation and drafting of regulatory dossiers and their submission to the notifying bodies.
The team’s multilingual skills and international connections enable it to set up optimised studies worldwide.
What’s more, our knowledge of the regulations applicable at the FDA and in other countries means that we can incorporate the relevant criteria for future extensions in the desired countries right from the outset.
Study design
We draw up the design or study plan, which enables us to establish a budget and schedule that are close to reality. This can then be used to submit an estimate for funding applications.
Writing the protocol
Centaur Clinical drafts the study protocol in accordance with current standards (ISO 14155, Good Clinical Practice, etc.), which is then submitted to the authorities for validation before the study begins. The protocol includes: type of study, duration, number of sites, primary and secondary claims (according to statistical methodology), number of subjects, inclusion and exclusion criteria and evaluation criteria.
Site selection
Thanks to its experience in clinical operations and past interactions with the various investigating centres and KOLs (Key Opinion Leaders), Centaur Clinical is able to select the most appropriate investigator sites for your study, in different specialities and different types of structures, including practices.
Regulatory submissions
Centaur Clinical drafts the regulatory documents to be submitted to the Notified Bodies (clinical evaluation report) and we take care of submitting the authorisation applications to the regulatory agencies/ethics committees (CPP, IRB), as well as the CNIL and the CNOM.
Implementation
Centaur Clinical’s Clinical Research Associates (CRAs) will provide you with all their expertise in setting up, monitoring and closing the study, in compliance with Good Clinical Practice.
Monitoring the study
Centaur Clinical has experienced and qualified CRAs who ensure that the study is conducted in accordance with the clinical investigation protocol and in compliance with regulatory requirements and applicable standards.
Data analysis
Centaur Clinical collects and analyses the data. A data management plan tailored to the needs of the study is put in place to ensure quality control of the database.
Clinical study report
Centaur Clinical analyses the preclinical and clinical data on the DM and draws up the final document to be submitted to the notifying body.
Post-market research
Centaur Clinical implements post-market clinical surveillance (PMCF) of your device according to MEDDEV2,12/2 Rev8. SCAC is a requirement of the new regulation 2017/45 and consists of collecting real-life clinical data in order to monitor the safety and performance of a medical device once it has been placed on the market and until the end of its life cycle.
Call on our team of experts for dedicated, optimised support
Because time is your ally, take advantage of our expertise and experience to bring your medical device to market.