RCTs is your partner of choice, for over 30 years, for the conduct of non-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 | ||