Medical Writing

Medical Writing

The success of a clinical development program hinges on the meticulous documentation of research plans and results. At Edenwell, our dedicated Medical Writing team plays a pivotal role in generating the essential documentation for study start-up. They are also responsible for transforming the intricate data generated during clinical trials into precise, comprehensible, and compliant documents for submission to regulatory authorities.

To uphold the highest standards, all our reports and associated Medical Writing deliverables undergo rigorous quality control checks and peer reviews as integral parts of our standard process. This meticulous approach ensures the harmonization of documents throughout the submission process. Adhering to stringent industry and regulatory standards, we guarantee that all reports not only meet but often exceed your requirements. This commitment to excellence in documentation contributes significantly to the overall success and regulatory approval of clinical development programs.

• Preparation of ICH GCP compliant Clinical study documents (Protocol, Informed Consent Forms, Investigator Brochures, Patient Narratives, and Clinical Study Reports).
• Common Technical Document (CTD) for EU and US Regulatory Authorities
• Pharmacovigilance; Periodic Safety Update Reports (PSUR), Preparation and Review of Annual Safety Reports (ASRs), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER).