Medical writing: pre-clinical and clinical expert reports
At Diapharm medical writing is an integral part of fulfilling regulatory and clinical requirements. For marketing authorisation dossiers, expert reports are prepared for the pre-clinical section with pharmacology and toxicology, and for the clinical section including efficacy and safety evaluations (CTD modules 2.4 to 2.7). The basis for these reports is the client’s own data and/or a thorough review of the literature.For clinical projects the required documents are developed, such as investigational medicinal product dossiers (IMPD), protocols, case report forms or final reports. Our services also include clinical evaluation of medicinal products and medical devices.
- Literature search and evaluation of available documents relating to the likelihood of a product being granted marketing authorisation.
- Medical statements
- Assistance with deficiency letters
- Pre-clinical and clinical expert reports, CTD modules 2.4 to 2.7
- Clinical evaluation of medicinal products and medical devices
- Medical documents for clinical trials (e.g. IMPD, protocol, CRF, final reports)
As part of our comprehensive project management services, Diapharm provides professional Medical Writing, for example for pre-clinical and clinical expert reports, and dealing with deficiency letters.
