Management of clinical trials and pre-clinical testing
The increasing standards for medicinal products, medical devices and foods must be planned for and implemented with optimal resource utilisation in mind. Providing evidence of the efficacy and tolerability of your product calls for an intelligent strategy, professional management for clinical trials, and careful documentation for submission to the relevant authority.At Diapharm, we plan optimal strategies for pre-clinical and clinical requirements and coordinate them at every stage. We also take into account current aspects of paediatric use in the paediatric investigational plan (PIP). Protocols and study designs are formulated for pre-clinical phases (pharmacodynamics, pharmacokinetics, toxicology) and for clinical efficacy and tolerability testing (phase I to phase IV and post-marketing surveillance studies; PMS). They are realised in cooperation with qualified and approved clinical research organisations (CROs) and biometricians. The fine-tuning and guiding of clinical projects with the help of scientific advice, as well as the subsequent approval process, are as much a part of our services as the preparation of the clinical study report and the integrating expert reports.
Our services include:
- Strategic planning of the study design
- Preparation of the IMPD (investigational medicinal product dossier), protocol, case report form (CRF), final report, etc.
- Discussions with regulatory authorities (e.g. Scientific Advice services)
- Coordination and implementation of bioequivalence testing
- Management of your clinical trial: phase I to IV, non-interventional trials (NIT or PMSS)
- Advising services for paediatric medicines, paediatric investigation plans (PIP): strategy and preparation
- Coordination of regulatory marketing authorisation procedures
Our management of your clinical trial accompanies the entire process from development of the strategy, including the paediatric investigation plan (PIP), to incorporating the results into the marketing authorisation application.
