Clinical trial management

Providing evidence of the efficacy and tolerability of a medicinal product calls for an intelligent strategy, professional management for clinical trials, and careful documentation for submission to the relevant authority

Clinical trial management

Our management of clinical trials accompanies the entire process from development of the strategy, including paediatric investigation plans (PIP), to incorporating the results into the marketing authorisation application or preparing the dossier for an early benefit assessment, if necessary.

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
• Early benefit assessment for paediatric use marketing authorisations (PUMA) and medicinal products with new active ingredients

For more information visit www.diapharm.com