A dedicated team of senior statisticians for your project:
Through our expertise in international coding and the use of standard international dictionaries, MedDRA and Who-Drug, we handle the medical coding of your study. Our experienced medical staf and pharmacist reviewer assure the accuracy of our coding.
Methodological advice & support for your study design
Subject number calculation & randomization lists
Interactive Voice and Web Response Systems
Statistical Analysis Plan with template of TGLs
Programming and validation of the results
Statistical reports according to ICH guidelines
We work with the technology leader: Oracle s RDC 4.6. This highly validated and wel-known system is one of the most reliable in the pharmaceutical industry and respects the international rules and guidelines (21 CFR part 11 compliance)
Thanks to our e-CRF solution, we can provide services adapted to the requirements of the industry and clinical studies. This tool alows us to reduce timelines and costs, to increase the quality of the data colected and to give an immediate visibility and real time decision.
Our e-solution also gives us the possibility to manage online questionnaires for the volunteers.