CLINICAL DATA MANAGEMENT AND SUPPORT Release Date: April 20, 1999 RFP AVAILABLE: N01DA-9-8097 P.T. National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to provide clinical trials support and data management resources in support of clinical trials. No actual clinical studies will be carried out under this contract. The work required for this contract includes: a) developing and preparing clinical protocols; b) preparing and filing the INDs; c) Food and Drug Administration (FDA) registration, and ongoing regulatory compliance; d) assistance with initiation, monitoring, and managing the clinical trials; e) performing data management; f) performing statistical analysis; g) drafting various reports including the final study report for the submission of INDs and NDAs. This will be a five year contract with options to extend for two additional years. Request for Proposals (RFP) No. N01DA-9-8097 will be available electronically on or about April 29, 1999, and may be accessed through the Internet at the following URL: http://www.nida.nih.gov/RFP/RFPList.html Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, Deliverables and Reporting Requirements, Special Requirements and Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. All information required for submission of an offer will be contained in or accessible through the electronic RFP package. Response to the RFP will be due on or about June 14, 1999. This is a total small business set-aside. This advertisement does not commit the Government to award a contract. Point of Contact: Michelle L. Scala Contracts Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3105, MSC 9543 Bethesda, MD 20892-9543 Telephone: (301) 443-6677 Fax: (301) 443-7595 Email: ms35n@nih.gov
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