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