Clinical Trials
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Interventional studies
epidemiological
retrospectives. Project management
. Medical writing (Synopsis, protocol, patient information documents, clinical report, article, abstract, poster)
. Regulatory submissions
. Data-management (Implementation of data collection tools, data cleaning)
. Selection, contracting and establishment of centers
. Data control (ARCs)
. Support to centers (TECs)
. Vigilance management
. Remuneration and closure of centers
. Statistics (sample justification and data analysis) -
Drugs
All clinical phases (RIPH1, RIPH2, RIPH3)
Many indications including oncology, neurology…
CAR-T cell, Innovative Medicines… -
Medical devices
Study management to demonstrate safety
and performance of theMD for EC marking
ISO 14155
Post-marketing study MDR 2017/745/EU -
Dermo-cosmetics
Class I to III
Post-marketing and non-interventional study
Collaboration with sites of excellence -
Nutrition
Health risk assessment and level of tolerance or allergy
Post-registration study for foods for medical purposes
Health claims
