Preparing Specific Clinical Documents

Trilogy’s Specific Clinical Document workshops are intended for medical writers with experience of clinical development, and are designed to provide the detailed knowledge required to produce the various clinical documents. Each workshop includes a review of the necessary content and message required by the individual document: how best to communicate and illustrate your message – and how best to satisfy regulation – by understanding thoroughly what regulators will be looking for.

Trilogy’s specific clinical document workshops are designed for experienced medical writers, physicians or clinical team members facing the challenge of preparing a specific type of clinical document for the first time – or for expanding the expertise and documentation skills of experienced medical writers to cover new documentation areas.

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Please contact us to see how we can help with your training needs.

Available Courses
D01The Clinical Study Protocol (CSP)
D02The Investigator’s Brochure (IB)
D03The Clinical Study Report (CSR)
D04The Paediatric Investigation Plan (PIP)
D05The CTD Dossier
D06 Safety Reports: PSUR/PBRER, DSUR, & RMP
D07The Lay Summary
D08Briefing Books for FDA and EMA