Managing preclinical programs into Phase I/II clinical trials

Challenge:

A leading cancer research charity needed project management and drug development expertise to shepherd two preclinical programs into Phase I/II clinical trials. Alacrita was engaged to provide an expert resource.

Solution:

Our duties included overseeing the formal preclinical development program, submission of IND and execution of a Phase I/II clinical trial for two of the charity’s targeted therapy compounds. We were responsible for the following:

• identifying and negotiating contracts with appropriate CROs
• managing the CRO relationships
• identifying and overcoming issues as they arose
• ensuring regulatory compliance
• liaising with ethics committees
• monitoring and ensuring GMP compliance
• providing regular progress reports