Drug Development Support for the Cancer Therapy Evaluation Program

This solicitation seeks proposals to provide drug development support services to the Cancer Therapy Evaluation Program within the National Cancer Institute. Services include regulatory affairs support, clinical research information management, adverse event tracking, preparation of FDA submissions, and on-site support for inspections. Proposals are due November 30th and will be evaluated based on personnel qualifications and experience, technical approach, corporate experience, facilities, and equipment. A transition from the incumbent is required within 90 days of award which will have a one year base period and four optional one year periods.

There is no set-aside designation. Services will be performed within the United States to support investigational anti-cancer agents and clinical research programs. Qualified offerors must demonstrate experience publishing FDA submissions in eCTD format, validating an eCTD application, and providing off-site fireproof storage within two hours of NCI in Rockville, MD. The contract type will be cost-plus-fixed-fee and support ongoing CTEP programs over multiple years.