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FBO DAILY ISSUE OF MARCH 10, 2011 FBO #3393
SOLICITATION NOTICE

R -- Services for Clinical Trial Operations and Management

Notice Date
3/8/2011
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541690 — Other Scientific and Technical Consulting Services
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
 
ZIP Code
20892
 
Solicitation Number
1954561
 
Archive Date
3/30/2011
 
Point of Contact
Jasmine D Snoddy, Phone: 301 594 1571
 
E-Mail Address
snoddyj@mail.nih.gov
(snoddyj@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This solicitation number is 1954561 and solicitation is issued as a request for quotation (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-49. Performance will be in Bethesda, Maryland. The National Institute on Drug Abuse on behalf of the National Institute of Mental Health has a requirement for Services for Clinical Trial Operations and Management. The Contractor will (1) assist the Division of Services and Intervention Research (DSIR) Director in management and oversight of the operations of two contract-supported Recovery After an Initial Schizophrenia Episode Initiative (RAISE)trials, (2) Provide mentoring to junior staff in the DSIR Clinical Trials Operations and Biostatistics Unit regarding operational oversight of large-scale clinical trials, (3) Participate in conference calls and/or individuals calls with operational components of RAISE contract teams, (4) Participate in the NIMH RAISE Stakeholders Meetings, RAISE Foundation of the National Institute of Health meeting, and other meetings as necessary, (5) Work with RAISE data management and coordination centers to oversee the monitoring of the implementation of both trails, (6) Work with RAISE data management and coordination center to oversee the NIMH Data Safety Monitoring Boards (DSMB) reporting requirements and to present to the NIMH DSMB meetings, (7) Review protocol and consent changes, as well as other implementation and operation procedures, (8) Work with RAISE projects to implement and oversee ancillary projects, such as the genetics blood collection protocols, (9) Work with DISIR program staff to develop expertise in specific technical areas related clinical trials management as directed by DSIR Director, and (9) Consult with DSIR program staff on operational aspects of other high profile projects as directed by DSIR Director. The total number of hours are 700 per annum. The period of performance is 12 months with two (2) option years. The provisions at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition. The provisions at 52.212-2, Evaluation Commercial Items, is applicable. Specific evaluation criteria: (1) Ability to provide clinical trial operations in the federal sector; (2) ability to coordinate various committees and stakeholders including the IRB and DSMB, (3) Experience with clinical trials in the mental health field, and (2) Prior efforts of similar scope and complexity. Offers will also be evaluated on best value in relation to price. Offerors Representations and Certifications Commercial Item, with its offer. Clause at 52.212-4, Contract Terms and Conditions Required to Implement Statues or Executives Orders Commercial Items, applies to this acquisition. The quotations are due on March 15, 2011 at 3:00PM EST and will be submitted hard copy or electronically to Jasmine Snoddy, Contract Specialist, 31 Center Drive, Room 1B59, Bethesda, Maryland 20892.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/1954561/listing.html)
 
Place of Performance
Address: Bethesda, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN02395736-W 20110310/110308234320-341bd98fb299b9ce1ffb7d364106358d (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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