Data and Statistics Center for the Clinical Trials Network

Notice Number: NOT-DA-05-020

RFP Available: N01DA-5-2207

Key Dates
Release Date: November 8, 2004

Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)

The National Institute on Drug Abuse (NIDA) plans to solicit proposals from qualified businesses to provide resources to support the Clinical Trials Network (CTN). The contract will provide data management and statistical analysis services in support of multi-site clinical trials conducted within the NIDA Clinical Trials Network (CTN). No actual clinical trials will be carried out under this contract. Rather, activities under this contract will support the trials carried out under cooperative agreements (U-10) with seventeen Regional Research and Training Centers (RRTCs) located across the nation. The trial studies include behavior, pharmacological, and integrated therapies in Community-based Treatment Programs (CTPs). The range of support services encompasses the following areas:

1) establishing and administering systems for the collection, management and storage of study data;

2) designing and performing all statistical analyses;

3) reviewing and monitoring the quality of study data;

4) monitoring trial progress;

5) preparing reports for the Data and Safety Monitoring Board;

6) providing support for protocol development in the areas related to the tasks specified in the Statement of Work;

7) participating in relevant committee and subcommittee meetings and conference calls; and,

8) providing other expert consultation and support services as needed.

We anticipate the award of one cost reimbursement contract for a base period of three years. The contract will include two 1-year options plus additional options to cover an increase in the number of RRTCs in the network. NIDA anticipates substantial subcontracting opportunities under this project. RFP No. N01DA-5-2207 will be available electronically on or about November 19, 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 January 18, 2005. NIDA will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Contact:

Pedro M. Godinez, Contracting Specialist
National Institute on Drug Abuse, NIH
Contracts Management Branch, OPRM
6101 Executive Blvd., Room 260, MSC 8402
Bethesda, Maryland 20892-8402
E-mail: pg186o@nih.gov
Telephone: (301) 443-6677
Fax: (301) 443-7595


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