Clinical and Laboratory Applied Regulatory Science

The Food and Drug Administration seeks clinical and laboratory applied regulatory science services through an indefinite delivery, indefinite quantity contract with a ceiling of $30 million over five years. The contractor must be capable of providing phase I clinical trial operations including protocol development, execution, and reporting, as well as bioanalytical methods, biomarker analyses, and final reporting for laboratory services. Proposals will be evaluated on technical qualifications, past performance, and price, with the award going to the offeror presenting the best value. The deadline for submission of proposals is July 17, 2019.

There is no set-aside designation for this procurement. The primary NAICS code is 541715 and PSC code R425. Performance will take place at 10903 New Hampshire Ave. in Silver Spring, Maryland. Security requirements are moderate for all contract objectives. The contractor must also comply with regulations regarding information security, personnel screening, and incident response.