Centaur Clinical Cro

Clinical trials

Pre and Post Market Research (PMCF)

Full support and care

Clinical trials

Study design

Writing the protocol

Site selection

Regulatory submissions

Implementation

Follow-up to the study

Data analysis

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Clinical study report

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.

To find out everything you need to know about clinical trials, download our white paper in .pdf format.

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.

TESTIMONIALS

Our satisfied customers are talking about us

We are starting a clinical investigation with Centaur Clinical and are very satisfied with our collaboration so far. Preparing the submission to the authorities is a stressful and time-consuming period that requires skilled staff. The Centaur Clinical teams are always ready to provide us with their expertise, availability and support.