Medical writing is an integral part of clinical research. The Medical Writing Unit at MDU is qualified and experienced in the production of Clinical Study Documents and Study Reports according to ICH GCP guidelines as well as a wide range of medical documentation required to support product development.
MDU Medical writers are able to provide trial support as well for country requirements. The documentation provided by our medical writers is clearly written and compliant with all ICH guidelines and regulatory requirements.
Our services include:
- Patient Related Information
- Supportive documents
- Preparation of documents for submission (remediation/publishing)
- Clinical Summaries/Overviews
- Briefing/Response Documents