Edsman Medical Writing
Regulatory and clinical documents
- Clinical study reports and protocols (Phase I–IV)
- Clinical summaries and overviews
- Risk management plans
- Paediatric investigation plans
- Safety update reports
- Regulatory briefing documents
- Lay summaries
- Advisory board reports
- Journal manuscripts
- Key paper summaries
Assurance of quality
Edsman Medical Writing prepares clinical and regulatory documentation in accordance with the International Conference on Harmonisation (ICH) guidelines and applicable regulatory requirements. Ingrid Edsman, MD, is an active member of the European Medical Writers Association (EMWA) and has completed the EMWA professional development programme at the foundation and advanced levels.
Please visit our website www.edmedica.se or call us for more information.