A -- CLINICAL TRIAL COORDINATION AND DATA MANAGEMENT SUPPORT FOR

Notice Date

September 27, 2000

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 6107, MSC 9603, Bethesda, MD, 20892-9603

ZIP Code

20892-9603

Solicitation Number

NIMH-01-DS-0002

Response Due

December 12, 2000

Point of Contact

Alex Navas, Contract Specialist, Phone (301) 443-2696, Fax (301) 443-0501, Email anavas@mail.nih.gov

E-Mail Address

Alex Navas (anavas@mail.nih.gov)

Description

The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposals (RFP) No. NIMH-01-DS-0002 entitled: _Clinical Trial Coordination and Data Management Support for NIMH_. This solicitation is classified as 100% Small Business Set-Aside under NAICC Code 541519. The NIMH plans to award one (1) task order type contract, with a five (5) year base period. Additionally, an option for an additional five (5) years is contemplated. The NIMH is seeking general clinical and data management and statistical services for multisite clinical research trials. The successful contractor/coordinating center will, as necessary, plan, administrate, and work with the clinical sites, the NIMH and the Statistical Investigator to accomplish the scientific goals of each multisite clinical trial in a high quality, timely and cost efficient manner. Each task order under this contract will require the performance of some of the Tasks listed below. Some trials may require all tasks, others only some. The Contractor will be told what level of service is required for each trial. * Submit a Work plan for each clinical trial; * Establish a uniform format and methodology for the multiple sites to collect data; * Develop and test central database management system, including subject treatment assignment system, query/resolution system and data inventories; * Monitor the quality of data from sites; * Provide the data and specified reports to the Government Project Officer; * Carry out Start-UP/Preliminary Phase Tasks; * Conduct quality assurance site visits; * Perform descriptive and appropriate statistical analyses during each study; * Develop and maintain an appropriate website for each trial. RFP No. NIMH-01-DS-0002 will be available on or about October 12, 2000, and the receipt date for proposals will be on or about December 12, 2000. The RFP may be accessed through the NIMH Home Page by using the following instructions: access the home page at http://www.nimh.nih.gov, select "Grants and Contracts", select "Contracts", select "NIMH Requests for Proposals (RFP)" and lastly select "RFP No. NIMH-01-DS-0002". Please note that the RFP for this requirement will include the Statement of Work, Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors included in the competitive range may be requested to provide additional documentation to the Contracting Officer. This advertisement does not commit the government to award a contract. Please contact Patricia L. Gibbons @ 301-443-2696 or email: pgibbons@mail.nih.gov for any additional questions.

Web Link

Visit this URL for the latest information about this (http://www2.eps.gov/cgi-bin/WebObjects/EPS?ACode=P&ProjID=NIMH-01-DS-0002&LocID=2927)

Record

Loren Data Corp. 20000929/ASOL004.HTM (D-271 SN501222)