Project Management - Preclinical Studies

The challenge:
A customer with a pharmaceutical substance in the initial clinical development phase, requiring further studies of the drug before the next phase of development.

Our role:
We evaluated the existing preclinical data in the project, identified the gaps and suggested additional studies. The project includes the outsourcing of studies (including the identification of suitable CROs) and order design, evaluation and compilation of results including an impact assessment and, finally, suggestions for further studies.

The result:
The preclinical studies are ongoing. Some studies have been completed and reports written. The assignment has been expanded to include non-clinical safety studies and their coordination.