Post-authorization studies on primary data

RCTs is your partner of choice, for over 30 years, for the conduct of non-interventional studies on drugs and medical devices in France and abroad.

The countries covered by RCTs via PSNResearch are:

You are a company that develops health products (drugs, medical devices) or an institutional sponsor, RCTs’ expertise will guide you through every dimension of your project:


Definition of evaluation criteria, comparator and experimental plan, sample size calculation, etc., in a synopsis
Medical writing:
Writing of the protocol according to current regulations and standards in force
Project managment:
Support, throughout the project, by a dedicated project manager. Management of planning, costs, and stakeholders
Regulatory submissions:
Depending on the concerned country/ies, submission to competent authorities, ethical committees, and other applicable committees.
Data management:
Implementation of tailored digital solutions (eCRF, ePRO, IWRS, eTMF, CTMS), patients’ profile editing, on-line data review, soft and hard locks.
Sites management:
Feasibility study, site selection, contractualization, initiation, follow-up, study product management, monitoring (on-site or remote, 100% or risk based) and close-out.
Statistical analysis:
Writing of statistical analysis plan, analysis under SAS, edition of Tables Figures and Listings (TFLs)
Medical writing:
Writing of study report according to regulations and standards in force
Scientific communication:
Writing of abstracts, posters, slides and publications

We have already accompanied them

Study requested by the Authorities

Our experts are available for you

Morgane Champiot
Head of Clinical Operations - Co-leader of the AFCROs’ Medical Device working group
Frédéric Mistretta
President – Co-leader of the AFCROs’ Real World Data working group

Next expertise

Secondary Data Studies Learn more

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partner to rely on ?


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