National Institute on Aging Clinical Trials Operations Support Center

This RFP is for the continued operation of the NIA Clinical Trials Operations Support Center (CTOSC) in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. This clinical trial support includes providing technical and administrative assistance to investigators in the areas of quality assurance and safety. The NIA is charged with ensuring the highest quality of the Institute-funded clinical research projects and compliance with HHS/NIH/NIA regulations regarding human subject protections and safety monitoring. Given that current NIA clinical trials portfolio includes more than 180 intervention studies and clinical trials ranging in size from 20 to 20,000 participants, NIA staffing levels are inadequate to perform all of these functions. In addition, NIA needs to assure application of consistent and effective clinical trial administrative practices, and to respond promptly and effectively to arising issues relating to its clinical trials. The proposed contract will be the second renewal of NIA's CTOSC. The contractor shall provide clinical trial professionals with the expertise to handle unanticipated clinical trial methodological, biostatistical and operational needs, in the following seven areas in order to support the management, tracking, and oversight of NIA funded clinical trials: 1) operations support for review, monitor and recommendation of changes to trials' quality assurance procedures; 2) safety-related operations support; 3) statistical and methodological consultation; 4) training of NIA staff on clinical trials administrative procedures; 5) maintenance of the NIA database on human intervention studies; 6) project management; and 7) transition planning and contract close out. The proposed contract period of performance for this requirement will be for five years from date of award, on/about September 25, 2017 through September 24, 2022.