Project management for clinical studies
Diapharm has a professional project management team for preclinical and clinical trials so that drug manufacturers can be sure that the safety, efficacy and tolerability of their product is tested efficiently – right through to the readability of the package leaflet.
The clinical trials management professionals provide expertise and regulatory know-how at an early stage in adopting the optimal strategy for preclinical development. They draft and coordinate suitable protocols and develop study designs, for example to investigate preclinical pharmaco¬dynamics, pharmacokinetics and for the toxicological testing of the drug. They also prepare preclinical expert reports (CTD module 2.4 and 2.6) and produce the essential dossier documentation
The project managers prepare clinical phases I to IV and post-marketing surveillance studies. Diapharm directs the whole clinical research process, from the selection of suitable and tried and tested study centres (clinical research organization, CRO) and biometric institutes through to documentation of the study. The preparation of an investigational medicinal product dossier (IMPD) and support during the approval process are among the services offered, as is presentation of the studies in the associated expert reports (CTD module 2.5 and 2.7).
| Clinical Management |
| development of protocols and study designs |
| coordination of clinical studies |
| documentation for the clinical dossier |
| readability user testing (read more) |
| advice on paediatric medicinal products |
| liaison with authorities |
| marketing authorisation procedure |
Once studies have been completed, the clinical trials managers also provide support during the further marketing authorisation procedure. Thus, the team offers a validated test of the readability of package inserts (readability user testing of patient information leaflets). Diapharm also liaises with the competent national and international authorities, processes deficiency letters and ensures that applications are processed quickly and on time – through to the granting of marketing authorization.
