Medical writing & Affairs: (Pre-)clinical expert reportsAt 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). In order to do this, Diapharm’s medical writers utilise data provided by the client itself and/or, if so agreed, perform 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. Our services also include clinical evaluation of medicinal products and medical devices. Or dossiers for the early benefit assessment, which are required for medicinal products with new active ingredients, and for paediatric use marketing authorisations (PUMA) with known substances.
As part of development projects, we write development plans, and our extensive experience in the project management of approval projects and in the area of regulatory affairs means that we can analyse the necessary tests and studies and devise intelligent solutions.
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.
- Literature research
- Evaluation of available documents
- Clinical evaluation of medicinal products and medical devices
- Medical writing for pre-clinical tests and clinical trials (e.g. IMPD, study design, study protocol, CRF, study report, final report)
- Medical writing for CTD dossiers: pre-clinical expert reports (CTD modules 2.4 and 2.6) and clinical expert reports (CTD modules 2.5 and 2.7)
- Summary of Product Characteristics (SmPC) and Patient Information Leaflets
- Assistance with deficiency letters
- Early benefit assessment dossiers
- Medical statements