EXPERTISES

 

Pre-Authorization Studies

RCTs has been your privileged partner for over 30 years for the implementation of interventional studies in France and abroad.

The countries directly 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 all the pathways of your project:

 

 Design:
Choice of endpoints, comparator, study design, sample size calculation, …
 Regulatory:
Type of studies according to the targeted countries.
 Site Selection and initiation:
Feasibility study, contract processing, initiation, …
 Monitoring:
Definition of the monitoring plan adapted to the context (centralized, on-site, risk-based monitoring).
 

 

IP release, management of randomization and investigational products
 Data Management:
Implementation of an adapted digital solution, edition of patient profiles, on-line data review, soft and hard locks.
 Analysis and exploitation of results:
Writing of the analysis plan, conduct of analyses with SAS, edition of TFLs.
 Medical writing:
Writing of the study report according to the standard in force (ICH or ISO), writing of the publication

We have already accompanied them

Large-scale international phase III study

Our experts are available for you

Alain Baleydier
General Manager - Head of Clinical Operations - Moderator of the AFCROs’ "Patients at the heart of clinical research" working group
Flavien Roux
Head of Interventional Studies 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