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:  [email protected]

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