A -- Statistical Analysis in Support of DPMC 's Clinical Trials

THIS REQUIREMENT IS A 100% TOTAL SMALL BUSINESS SET-ASIDE. The North American Industrial Classification System (NAICS) code identified for this requirement is 541710 with a size standard of 500 employees. The National Institute on Drug Abuse (NIDA) plans to solicit proposals from qualified small business concerns to provide statistical services in support of Phase 1, Phase 2, and/or Phase 3 clinical trials coordinated by the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMC). This contract will: a) provide biostatistical input into the study design, b) prepare the statistical analysis plan, c) conduct statistical analysis of study results, including interim data, d) prepare statistical reports for IND/NDA submission, e) design and generate subject randomization schedules, f) perform additional programming in order to conduct ad hoc data analyses, g) provide statistical consultation and present study results in meetings and h) review and approve Case Report Forms (CRF). Clinical trials will not be carried out under this contract. NIDA anticipates that this solicitation will result in the award of multiple contracts. The contracts will have a three-year base period and include two 1-year option periods. RFP No. N01DA-5-8855 will be available electronically on or about December 27, 2004. You will 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). Please note that NIDA uses a streamlined RFP format, which includes only the Work Statement, Deliverables, Reporting Requirements, Special Requirements, Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for the submission of a proposal is contained in or accessible through the streamlined RFP package. Response to the RFP will be due on or about February 18, 2005. This advertisement does not commit the Government to award a contract. See Notes 1 and 26.