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:
| Design: | ||
| 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 | ||