Pre-Authorization Studies

RCTs is your partner of choice, for over 30 years, for the conduct of 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

Large-scale international phase III study

Our experts are available for you

Morgane Champiot
Head of Clinical Operations - Co-leader of the AFCROs’ Medical Device working group
Flavien Roux
Head of Biostatistics

Next expertise

Post-authorization studies on primary data Learn more

Do you need a strong
partner to rely on ?


Let’s talk about it