RCTS

RCTs is an international full-service CRO based in Lyon, with over 35 years of experience, that supports manufacturers in the clinical and regulatory development of their medical devices.

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Our team can accompany you throughout all stages of your clinical investigations (pre-CE-marking or PMCF, based on primary or secondary data, national or international):

• Study design (methodology establishment, synopsis)

• Medical writing (protocol, report, abstract, poster, slides, publication)

• Project management

• Regulatory submissions

• Data management (tailored digital tools, data review, locks)

• Sites management (feasibility, sites selection, contractualization, initiation, follow-up, monitoring and close-out)

• Statistical analysis (statistical analysis plan and analysis).

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Our experts specialized in medical devices can also support you with your clinical evaluations in compliance with European Regulation 2017/745:

• Clinical evaluation strategy

• Clinical evaluation plan and report (CEP and CER)

• Post-market clinical follow-up strategy

• Post-market clinical follow-up plan and report (PMCFP and PMCFR).