Clinical Studies Management and Support (CSMS)

The National Heart, Lung, and Blood Institute intends to award a sole source contract to Navitas, Inc. to provide Clinical Studies Management and Support services. The services include clinical research management, oversight and operations support for studies funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Specific tasks encompass areas such as monitoring, safety oversight, training, database and systems maintenance, and general administrative services. Interested parties were invited to submit capability statements by June 7th outlining their experience and qualifications to potentially compete for this requirement in the future.

There is no set-aside designation for this procurement. The contract would be awarded for a period of two years starting in August 2021, with an anticipated value of $X. Key services required under the contract include clinical research management and oversight support, risk-based monitoring of selected clinical studies, statistical review and consultation, training and education of NIH staff and investigators, and maintenance of electronic systems including a clinical studies database. Interested parties were invited to submit capability statements by June 7, 2021 to be considered for this requirement.