NIA Clinical Trials Operations Support Center

The National Institutes of Health (NIH), National Institute on Aging (NIA) proposes to issue a Request for Proposals (RFP) No. NIH-AG-2011-159, "NIA Clinical Trials Operations Support Center" under the authority of Federal Acquisition Regulation (FAR) 19.5, Set-Asides For Small Business, using acquisition procedures of FAR Part 15. The objective of this contract is to continue operation of the 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 contractor will provide clinical trial support in the interpretation and implementation of quality assurance guidelines for specific clinical studies; maintenance of the NIA Clinical Research Study Investigator's Toolbox, a web based informational resource for researchers ensuring data quality and integrity; training to the Principal Investigator (PI) and staff on how to perform an internal audit or other study monitoring activities; maintenance of the NIA Safety Training Course; review of the awardees' clinical trial materials and reports to ensure participants' safety and alert the NIA's program staff about emerging safety concerns with studies, as well as recommend possible corrective actions to eliminate or decrease risks to study participants, and will perform other tasks as described in the Statement of Work. NIA is currently supporting approximately 78 clinical trials ranging in size from 20 to 20,000 participants. The Contractor may be asked to provide assistance, assessment, or consultation to any of the NIA funded clinical studies/trials. The NIA will issue task orders to the contractor for the services described in this statement of work, and deliverables required under a particular work area will be required for each task order issued. Each task order will be individually funded when issued. Sources must meet the small business size criteria under NAICS code 541712 at the time of submission of original proposals: A five (5) year contract is contemplated. Plans are to award a contract by July 30, 2012. Solicitation NIH-AG-2011-159 will be available on or about December 15, 2012, and the receipt date of proposals on or about January 31, 2012. The RFP may be accessed through http://www.fedbizopps.gov. Please note that the RFP for this requirement will include the Statement of Work, Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible small business sources are encouraged to submit a proposal that will be considered by the NIA. This advertisement does not commit the Government to award a contract. Please contact Sara McLaurin, Contracting Officer at 301-443-9154 or mclaurinsm@nida.nih.gov for further information.