MEDICAL EXPERTISE AND CLINICAL TRIALS
When medical questions have to be explored with a scientific eye in a regulatory framed clinical investigation
Big pharma, biotech, medtech, researchers: are you willing to develop clinical trials in Europe for market access? Looking for a medical expertise to draft or review your protocol before submission to the FDA? In need of an EDC solution for your international trial? Doing a publication based on a meta-analysis that requires publication screening, data collection and analysis and publication drafting
Our medical and clinical expertise addresses life sciences industry at each stage of your project, in order to…
1 / Brainstorm and design the study
Our Medical and Scientific writing team sets up the project with you by screening the appropriate e literature and drafting all the essential documents: synopsis, protocol, CRF…
2 / Coordinate clinical Operation and Biometry
In Europe, we take care of regulatory submissions, clinical investigation and investigator recruitment and management, including onsite monitoring. Our biometry activity goes beyond borders and our data managers and biostatisticians can fulfill all your demands regarding data management and analysis.
3 / Deliver scientific and medical supports
The medical and scientific team concludes the project by translating statistical results into medical deliverables: clinical report, article/publication, poster, medical education support…
For more information, see our CRO dedicated website.
Design, synopsis, protocole, CRF, eCRF, regulatory submission, clinical trial, randomization, RCT, ePRO, recruitment, clinical operation, monitoring, CRA, data management, biostatistics, statistical analysis plan, SAP, medical writing, clinical report, article, publication, poster, ICH, CDISC, SDTM, ADaM, CE marking,