SOURCES SOUGHT
A -- NIA Clinical Trials Operations Support Center
- Notice Date
- 6/29/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIH-AG-RDSS-2011-159
- Point of Contact
- Sara M. McLaurin, Phone: 3014439154
- E-Mail Address
-
mclaurinsm@nida.nih.gov
(mclaurinsm@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS : This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. BACKGROUND The National Institute on Aging (NIA) is currently supporting approximately 78 clinical trials ranging in size from 20 to 20,000 participants. The NIA is charged with ensuring the highest quality of each Institute-funded clinical research project and compliance with Department of Health and Human Services (DHHS)/National Institute of Health (NIH)/ NIA regulations regarding human subject protections and safety monitoring. In response to these crucial quality assurance and compliance needs, the NIA has a requirement for clinical trial operations support. This support includes development, implementation, and maintenance of effective clinical trial quality assurance and safety surveillance programs, statistical consultations, Data Safety Monitoring Board (DSMB) support, on-site data assessments, and training in clinical trial procedures. PURPOSE AND OBJECTIVES The purpose of this contract is to continue operation of the NIA Clinical Trials Operations Support Center (CTOSC) in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. The Contractor may be asked to provide assistance, assessment, or consultation to any of the NIA funded clinical studies/trials, including administrative functions regarding participants' safety, study operations, data quality, and statistical support, and training in clinical trial procedures for NIA staff and NIA-funded investigators. The NIA will issue task orders to the contractor for the services in accordance with the statement of work. Deliverables required under a particular work area will be required for each task order issued. Each task order will be individually funded when issued. PROJECT REQUIREMENTS The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, in order to serve as a Clinical Trials Operations Support Center. The contractor shall provide scientific resources and services necessary to support a broad range of activities required to effectively manage the NIA clinical trials, requiring advanced expertise in the design, conduct, analysis, and oversight of clinical trials. Seven distinct performance areas have been identified as follows: • Clinical trials operations support and quality assurance • Safety-related operations support • Biostatistical support • Training of NIA staff in clinical trials administrative procedures • Maintenance of the NIA database on human intervention studies • Contract Management • Contract Transition and Closeout REPORTS/DELIVERABLES Contract deliverables shall be submitted as required for each Task Order that is issued. Semi-Annual Progress Reports and a Final Progress Report shall be submitted for each Task Order. Other deliverables required will be specified in each Task order that is issued, and may include the following: Performance and Operating Plan; Report of Suggested Changes to Investigator's Toolbox; Standard Operating Procedures Manual for Assessments of Quality Assurance Procedures to Monitor Compliance with Guidelines, Regulations Governing Clinical Trials; Confidentiality Affidavit; Site Visit Report; NIA Safety Training Course Modification Proposal; Standard Operating Procedures Manual for Reviewing Clinical Trial Materials for Safety Monitoring Procedures; Safety Monitoring Procedures Review Report; Quarterly Serious Adverse Event (SAE) Summary; Meeting Minutes; Statistical Support Task Report; Consultation Materials; Summary of Consultation Session. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is from 7/1/12 through 6/30/17. OTHER IMPORTANT CONSIDERATIONS The North American Industry Classification System (NAICS) Code 541712 with a size standard of 500 employees is being contemplated. CAPABILITY STATEMENT/INFORMATION SOUGHT Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5-10 pages, single-spaced), indicating previous experience and capabilities related to the described work to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than July 15, 2011, at 2:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to mclaurinsm@nida.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Sara McLaurin, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address : Contracts Management Branch 6001 Executive Blvd, Rm 8154, MSC 9661 Bethesda, Maryland 20892-9661 Primary Point of Contact. Sara M. McLaurin, Contracting Officer mclaurinsm@nida.nih.gov Phone: (301) 443-9154 Fax: (301) 443-0501
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