Medical writing
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Medical Writing Services
Translate your research and data into intelligible literature to ensure regulatory success
With strong scientific backgrounds and knowledge of GCP and ICH guidelines, our medical writers produce high quality, evidence-based scientific, technical, medical and regulatory documents for a broad variety of promoters across all therapeutic areas.
Our custom approach allows us to use in-house or sponsor-supplied document templates. All the documents we produce undergo rigorous scientific, statistical, editorial and quality control reviews to ensure content, format, and style conformity in order to meet global technical and regulatory requirements.
We can help you with:
- Investigators’ brochures (IB)
- Investigational Medicinal Product Dossier (IMPD)
- Synopsis / Protocol and amendments
- Informed Consent form / Patient Information
- Case Report Form / Patient Diary
- Clinical study report in line with ICH E3
- Vigilance documents, safety reports, narratives and updates
- Interim report
- Participation in abstracts / posters / publications