Medical Writing

We offer medical writing services as an integral part of the clinical trial program or as a stand-alone service.
We will assist at all steps in the product development cycle, from preclinical through Phase I to Phase IV, following the ICH guidelines and in accordance with the most stringent regulatory requirements. Our medical writers have extensive professional expertise in most therapeutic areas and in a broad variety of clinical research documents, regulatory submissions, and other study documents to be issued. Our medical writing services include but are not limited to:

1. Protocols and protocol amendments.
2. Investigator Brochures.
3. Clinical sections of common technical documents (CTDs).
4. Informed Consent Forms/Patient Information Leaflets.
5. Clinical study reports.
6. Integrated summaries of safety/efficacy.
7. Literature summaries.
8. Medical communications including Manuscripts, Abstracts, Journal articles, Posters, etc.