SOURCES SOUGHT
A -- National Institute on Aging Clinical Trials Operations Support Center
- Notice Date
- 8/12/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-SBSS-16-019
- Archive Date
- 9/13/2016
- Point of Contact
- Kim Stapleton, Contract Specialist, Phone: 301 443-3775, Yvette Brown, Phone: 301 443-2696
- E-Mail Address
-
kim.stapleton@nih.gov, Yvette.Brown@nih.gov
(kim.stapleton@nih.gov, Yvette.Brown@nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. INTRODUCTION/BACKGROUND The National Institute on Aging (NIA) is charged with ensuring the highest quality of each Institute-funded clinical research project and compliance with HHS/NIH/NIA regulations regarding human subject protections and safety monitoring. In order to accomplish these objectives, the NIA requires clinical trial-related scientific and management resources of the NIA Clinical Trials Operations Support Center (CTOSC). The NIA is currently supporting over 180 clinical trials ranging in size from 20 to 20,000 participants. PURPOSE/OBJECTIVES The purpose of this project is to continue operation of the CTOSC in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. The Contractor shall provide clinical trial support in the interpretation and implementation of quality assurance guidelines for specific clinical studies; maintain the NIA Clinical Research Study Investigator's Toolbox, a web based informational resource for researchers ensuring data quality and integrity; train the clinical trial Principal Investigator (PI) and staff on how to perform an internal audit or other study monitoring activities; maintain the NIA Safety Training Course; review awardees clinical trial materials and reports to ensure participants safety and alert the NIA program staff about emerging safety concerns with studies, as well as recommend possible corrective actions to eliminate or decrease risks to study participants. PROJECT REQUIREMENTS/SCOPE OF WORK 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 CTOSC. 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 (7) distinct performance areas have been identified and described in detail as follows: (1) Project Management; (2) Clinical Trials Operations Support and Quality Assurance; (3) Safety-Related Operations Support; (4) Statistical and Methodological Consultation; (5) Training of NIA Staff in Clinical Trials Procedures; (6) Maintenance of the NIA Database on Human Intervention Studies; and, (7) Transition Plan and Contract Closeout. The Contractor shall provide Project Management planning and implementation services so that both the Contractor and NIA can monitor and manage activities in each of the above seven (7) performance areas. The project management planning and implementation services will include the following requirements: (1) Annual Performance Plan, (2) Monthly and Annual Progress Reports, (3) Availability, and (4) Email and Internet Access. The Clinical Trials Operations Support and Quality Assurance performance area is to ensure that the data resulting from a trial are of highest quality and are considered valid and credible within the scientific and clinical community. In order to accomplish this objective, the Contractor shall provide assistance and guidance from experts in clinical trial quality assurance. Specifically, the Contractor shall provide scientific resources to review, monitor, and recommend changes (if needed) to the quality assurance procedures in NIA-funded clinical trials. The overall objective of Safety-Related Operations Support is to ensure that no participant enrolled in the NIA-funded clinical trial is exposed to unnecessary or excessive risk while participating in a trial. To assist the investigators in meeting this objective, the Contractor shall provide expert assistance and guidance in safety surveillance and shall provide scientific resources to review, monitor, and recommend changes, if required, to the safety surveillance programs in the NIA-funded clinical trials. Statistical and Methodological Consultation may be required as follows: 1) to evaluate requests to submit applications for large clinical research studies; 2) to help solve methodological problems in ongoing clinical projects; and 3) to perform additional statistical analyses of existing datasets and de-identification of the trial datasets in preparation for data sharing. The NIA anticipates that during the contract period of performance there will be new policies and regulations regarding subject protection, confidentiality and safety, and other clinical trial issues. Training of NIA staff in Clinical Trials Procedures is for interpreting and implementation of new policies and regulations. The Contractor shall assist the NIA program staff in the maintenance of the NIA Human Interventional Studies database, a tracking system for all interventional study grants and contracts. This readily accessible database provides rapid reporting of all interventional clinical research projects supported by NIA. The Contractor shall plan for an orderly Transition Planning and Contract close out procedures at the end of the contract. REPORTS/DELIVERABLES The following reports will be required: (1)Annual Performance Plan; (2) Monthly Progress Report; (3) Annual Progress Report; (4) Investigator's Tool Box Report; ( 5) Confidentiality Affidavit; (6) Site Visit Report; (7) NIA Safety Training Course Modification Proposal; (8) Safety Monitoring Procedures Review Report; (9) Quarterly Serious Adverse Event (SAE) Summary; (10) Safety Report Review; (11) CTAP/DSMB Meeting Minutes; (12) Statistical Support Task Report; (13) Consultation Materials. ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance is five (5) years from date of award. The estimated time frame for award is on or about July 2017. OTHER IMPORTANT CONSIDERATIONS The Government is expected to use procedures in FAR Part 15, Contracting by Negotiations. The North American Industry Classification System (NAICS) Code 541990 with a size standard of $15 million dollars. CAPABILITY STATEMENT/INFORMATION SOUGHT Respondents to this notice must provide, as part of their response, a capability statement 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 a 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, (3) any other information that may be helpful in developing or finalizing the 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 (2) original copies via mail and one electronic copy via email; (6) responses should be received no later than August 29, 2016 at 4:00 PM (EST); (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 kim.stapleton@nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Kim Stapleton, National Institutes of Health, Office of Acquisitions, NIDA Neuroscience COAC, NIMH/NIA R&D Contracts Management Branch, 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-SBSS-16-019/listing.html)
- Place of Performance
- Address: United States
- Record
- SN04221765-W 20160814/160812234759-7c69e8ceab4e334efe337e618d4dc5e8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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