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). | ||
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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 | ||