Clinical Coordinating Center for NIDA CCTN

THIS REQUIREMENT IS A 100% TOTAL SMALL BUSINESS SET-ASIDE. The North American Industrial Classification System (NAICS) code identified for this requirement is 54171 with a size standard of 500 employees. The National Institute on Drug Abuse (NIDA) is soliciting proposals from small business concerns to provide resources to support for multiple and simultaneously-running multi-site clinical trials conducted under the National Institute on Drug Abuse Center for the Clinical Trials Network (CCTN). The purpose of this contract is to provide a wide range of clinical trial administrative support and related services for multi-site clinical trials conducted within the NIDA Clinical Trials Network (CTN). No actual clinical trials will be carried out under this contract. Activities under this contract will support the trials carried out under cooperative agreements (U-10) with Regional Research and Training Centers (RRTC) located across the nation. The work required under this contract includes: 1) Providing support for regulatory functions and requirements; 2) Reviewing and monitoring protocol implementation; 3) Providing training to research staff; 4) Providing pharmaceutical services and clinical support; 5) Providing drug testing and analytical laboratory services; 6) Providing support for protocol development in the areas related to the tasks specified in the Statement of Work; 7) Participating in relevant committee and subcommittee meetings and conference calls; and, 8) Providing other expert consultation and support services as needed. NIDA anticipates awarding a three-year contract with options to extend for two additional years plus options to cover an increase in the number of RRTCs in the network. RFP No. N01DA-10-2221 will be available electronically on or about January 26, 2010. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website: (URL: http://www.nida.nih.gov/RFP/RFPList.html). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Response to the RFP will be due on or about March 15, 2010. Any responsible small business concern may submit a proposal that will be considered by the Government. Following proposal submission and the initial review, the Contracting Officer may require additional documentation from offerors in the competitive range. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice. This advertisement does not commit the Government to award a contract.