Clinical Project Management (CPM) plays a central role for the clinical program. Our mission starts with a research hypothesis and ends with a clinical study report. We provide the client with the required support and oversight of activities for the study, including writing the protocol and coordinating its development, as well as communicating directly with the contract research organisations (CROs) and regulatory authorities. We can act as clinical project managers side by side with the client or support only specific activities depending on the client’s operations.
Taking advantage of SDS strong expertise in medicinal products and biostatistics we can expand our services to combination products (drug-device/biologics-device), medical devices for in-vitro diagnostics or to products for which the applicable regulation is unclear.
- Ensuring that the design of the study is feasible from a regulatory and clinical point of view.
- Finding the best solution for the optimal price.
- Acting as a Clinical Project Manager with overall responsibility for the drug development in close collaboration with the client.
- Delivering a high quality clinical report that meets the authorities’ standards.