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.
|D01||The Clinical Study Protocol (CSP)|
|D02||The Investigator’s Brochure (IB)|
|D03||The Clinical Study Report (CSR)|
|D04||The Paediatric Investigation Plan (PIP)|
|D05||The CTD Dossier|
|D06||Safety Reports: PSUR/PBRER, DSUR, & RMP|
|D07||The Lay Summary|
|D08||Briefing Books for FDA and EMA|