Clinical Development & Research Documents
We create, review, and/or update…
- Research protocols and amendments
- Informed consent forms
- Investigators brochures (IB)
- Summary of changes documents
- Investigational medicinal product dossiers (IMPDs)
- Patient information leaflets
- Clinical study reports (full, abbreviated, interim, and synoptic)
- Patient-level and event-level safety narratives
- Annotated bibliographies