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COMMERCE BUSINESS DAILY ISSUE OF APRIL 5,1999 PSA#2317National Institute on Drug Abuse, Contracts Management Branch, 6001
Executive Blvd., Room 3105, MSC 9543, Bethesda, MD 20892-9543 B -- CLINICAL DATA MANAGEMENT AND SUPPORT SOL N01DA-9-8097 POC
Michelle L. Scala -- Contract Specialist, Contracting Officer -- Nancy
A. Hurd, Phone: (301)443-6677, FAX: (301)443-7595 WEB: NIDA RFP Home
Page, http://www.nida.nih.gov/RFP/RFPList.html. E-MAIL: Point of
Contact -- Michelle L. Scala, ms35n@nih.gov. 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. 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 address: (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. Following proposal
submission and the initial review process, offerors comprising the
competitive range may be requested to provide additional documentation
to the Contracting Officer. 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.
Posted 04/01/99 (W-SN315120). (0091) Loren Data Corp. http://www.ld.com (SYN# 0022 19990405\B-0004.SOL)
B - Special Studies and Analyses - Not R&D Index Page
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