EXPERTISES

 

Post-authorization studies on primary data

RCTs is your privileged partner 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 real-world assessment project:

 

 Design:
Assessment of the study design and potential biases, choice of endpoints, choice of possible comparator and customized experimental plan, sample-size calculation and justification …
 Regulatory:
Type of studies according to the targeted countries.
 Site Selection and site initiation:
Feasibility study, contract processing, site initiation, …
 Monitoring:
Definition of the monitoring plan tailored to the context (centralized, on-site, risk-based monitoring).
 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

Study requested by the Authorities

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
Frédéric Mistretta
General Manager - Head of Biometry - Co-pilot of the AFCROs’ Real World Data working group

Next expertise

Secondary Data Studies Learn more

Do you need a strong
partner to rely on ?

 

Let’s talk about it