Clinical Research Coordinating Center for NIDAs Clinical Trials Network

THIS REQUIREMENT IS A 100% SMALL BUSINESS SET-ASIDE. The North American Industrial Classification System (NAICS) code applicable to this requirement is 541712.

The National Institute on Drug Abuse (NIDA) plans to solicit proposals from small business concerns having the capability to provide a wide range of clinical trial administrative and research support and related services for multi-site clinical trials conducted within the NIDA Clinical Trials Network (CTN). The awardee will not be responsible for actually conducting clinical trials to be carried out under this contract. Activities under this contract will support the trials carried out under cooperative agreements with CTN grantees 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 research support;
5) Providing drug testing and analytical laboratory services;
6) Providing support for protocol development;
7) Participating in relevant committee and subcommittee meetings and conference calls; and
8) Providing other expert consultation and support services as needed.

It is mandatory that offerors possess a Drug Enforcement Agency (DEA) Research Registration for Schedules II to V in order to handle substances under the Controlled Substances Act of 1970. In addition, the successful offeror must either possess, or demonstrate the ability to obtain a DEA registration for Schedule I controlled substances.

NIDA anticipates awarding one cost reimbursement, severable, level-of-effort contract with a base period of one year with four option years. In addition to the options to extend the contract period of performance, option quantities are also anticipated.
RFP No. N01DA-15-2243 will be available electronically on or about January 23, 2015. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov) or through the NIDA website: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

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.