ChemDiv chemistry of cures

Our work with clients is a partnership and we are fully invested in the quality of the final product. ChemDiv performs all standard clinical services including project management of the overall study. From feasibility surveys, to site identification and recruitment estimates to reviewing or writing the study protocols, to providing regulatory guidance and submission of the regulatory packet to the Russian regulatory authorities we adhere to the highest standards of excellence.

We are fully invested into each clinical trial. Our project managers personally oversee all vendors associated with the study. These vendors include the central lab, data management, biostatistics and logistics (warehousing of clinical materials). Through dedicated oversight of the study team members, a project will move forward in an expedited fashion while maintaining the highest standards of excellence.

Our clinical project managers (CPMs) are selected for each study based on their experience and knowledge of the therapeutic area. The CPM will be involved from initiation, planning and execution of the clinical trial. They are able to review and provide feedback of the clinical protocol as well as verify that sites selected for the study are trained in the study protocol and have adequate patients and facilities to conduct the trial.

CPMs are also responsible for overseeing and providing guidance to the Clinical Research Associates (CRAs) as well as managing internal and external vendors in order to provide the highest quality services to our clients. CPMs are expected to be pro-active in their management approach in order to maintain timelines and budgets.

Find attached:

ChemDiv-Clinical_Development.pdf

See Also:

Regulatory Management
Medical/Safety
Vendor Management
Key Opinion Leaders