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. | ||