Our professionals from the Medical Writing Department have a wealth of experience, both clinical and in the preparation, translation and adaptation of trial documentation. Their expertise assures documents fully compliant with Good Clinical Practice (GCP) and all client and regulatory requirements.
Study protocol, Clinical Investigation plan, Synopsis
Preparation/adaptation of informed consent forms
CRF preparation – paper based and eCRF
Clinical Study report
Review of Investigators Brochure, SmPC, PIL and Dossier
Translation of client study documents into local language