Study initiation documents
The drafting of protocols (including synopses and amendments) or clinical investigation plans is carried out by medical writers or clinical project managers.
They may be in charge of carrying out the bibliographic analyses necessary for the rationalisation of the protocol.
The development of other documents is possible:
- Investigator brochure
- Information note and informed consent forms
- Paediatric consent forms
- Support for the drafting of the experimental drug file
- Publications on Internet Registries (EudraCT, clinicaltrials.gov)
End of study documents
All written reports are validated internally by another medical writer and/or a biostatistician who guarantees the reliability of the results as well as the good understanding of the methodologies applied during the statistical analysis.
Documents written in English are reviewed by a native English speaker.
In addition to clinical study reports, they can also take care of the drafting of temporary use authorisation (TUE) reports, the registration of results in the clinical trial database and the drafting of scientific articles and publications.
They are also at your service to draft all documents specific to international submissions, including safety reports.
They can also write a clinical evaluation report (CER), a post-marketing clinical follow-up plan or report (PMCF) for medical devices.