Our experienced team will be the privileged partner to carry out your Clinical Research projects: Phase I-II-III-IV clinical trials, observational studies, pharmaco-economic studies, real world studies… Thanks to our expertise in Clinical Research we will advise you on the best strategic choices in different therapeutic areas and guide you through all clinical development stages. In addition, our knowledge of the French, European and international regulations will provide you with the global vision necessary for the success of your clinical development projects.
We review all the documentation required for your clinical project and write the following documents :
- Clinical Investigation Plan and Synopsis
- Investigator’s Brochure
- Clinical Study Report
- Common Technical Document
- Investigation Report…
We also offer statistical expertise including :
- Choice of clinical trial methodology / Sample size calculation
- Writing the statistical analysis plan and the statistical analysis report
- Data Management and CRF/ eCRF implementation
- Data Analysis (Modelisations, hypothesis testing , Real World Data…)
- SAS® / R programmation.
- IDMC / DSMB management….
