SOURCES SOUGHT
99 -- TBTC Monitoring Sources Sought
- Notice Date
- 3/5/2020 4:11:27 AM
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- CDC OFFICE OF ACQUISITION SERVICES ATLANTA GA 30333 USA
- ZIP Code
- 30333
- Solicitation Number
- 67869
- Response Due
- 3/20/2020 12:00:00 PM
- Archive Date
- 03/21/2020
- Point of Contact
- Candice Simmons, Phone: 7704881432
- E-Mail Address
-
iie3@cdc.gov
(iie3@cdc.gov)
- Description
- Tuberculosis Trials Consortium Monitoring Division of Tuberculosis Elimination, Clinical Research Branch Background:� This is a SOURCES SOUGHT NOTICE to determine the availability of potential small businesses (e.g., 8(a), service-disabled veteran owned small business, HUBZone small business, small disadvantaged business, veteran-owned small business, and women-owned small business) in accordance with FAR 7.104(d).� The potential small business will need to demonstrate the ability to provide monitoring and other support to the clinical trials and clinical research performed by the TBTC throughout the five-year performance period 2020 -2025.� For the TBTC network, emphasis will be given to studies of latent TB infection in the United States, and studies of active TB disease both domestically and internationally.� � History: Since the late 1940s the U.S. Public Health Service (USPHS), and the Department of Veterans Affairs have conducted studies of anti-TB medications. In the 1960�s, the U.S. TB control and clinical research programs were transferred from their original location in Washington DC to the National Communicable Disease Center (now CDC) in Atlanta.[1] In the 1980s, when funding for TB control was declining, support for TB drug trials also diminished. With the resurgence of TB, strong federal support for TB control was restored in 1992. CDC renewed its engagement with TB clinical trials in 1993; an open competition funded a group of trial-capable sites for a period of 5 years (1993�1998). Among site characteristics sought were access to significant numbers of TB patients, experience in the conduct of clinical trials, the presence of a highly qualified clinical team, and a credible plan for recruitment, management, and follow-up of trial participants. This trial, initially named USPHS Study 22, enrolled 1,075 TB participants from sites in the U.S. and Canada.[2]� In 1997 CDC and the investigators from these sites decided to reorganize their activities, creating the TB Trials Consortium, or TBTC.� TBTC is based in the Clinical Research Branch (CRB) of CDC�s Division of Tuberculosis Elimination (DTBE). Formal by-laws for TBTC were adopted in 1998, establishing a central Steering Committee, made up of one representative from each TBTC site and one from CDC, as well as several executive committees:� Core Science Group (CSG); Implementation and Quality Committee (IQC); Publications and Presentations committee(P&P); and Advocacy and External Relations (AER). The purpose of the Steering Committee was to develop a long-term comprehensive scientific agenda for the TBTC. An Executive Affairs Group (EAG), composed of committee chairs and CRB leadership, was to serve as the executive arm of the Steering Committee, and was responsible for day-to-day decision-making.�� A new solicitation proposes to award contracts to a new group of TBTC trial site of which the expert monitoring skills of a contract research organization (CRO) will be required.� It is the intent of the DTBE that TBTC continue its efforts to conduct therapeutic, diagnostic, and preventive research in support of the CDC goal of TB elimination.� Clinical research monitoring of the TBTC clinical trials must be relevant to those locations where the research is conducted, and programmatically relevant to the TB control program of the United States and the mission of domestic TB elimination.� This monitoring contract requirement will be for a five-year period from 2020 through 2025.��� Describe the work:� The NAICS code associated with this requirement is 541690, �Other Scientific and Technical Consulting Services�. The associated size standard is $16.5 Million. Furnish all necessary services, qualified personnel, material, equipment, and facilities to conduct monitoring activities for the TBTC clinical trials sites. � Conduct Planning, Pre-Study, and TBTC activities to include the following: Establishing a project team, author meeting minutes and internal Standard Operating Procedures (SOP), Develop and maintain study procedure manuals, and Identify and establish contractual agreements with clinical research vendors to support study needs. Conduct TBTC Clinical Site Management and Monitoring activities to include: Ensuring the TBTC is operating in compliance with various international and domestic protocols, practices (Good Clinical Practice, Good Clinical Laboratory Practice), Human Subjects Projection and all applicable regulatory and local requirements, Ensuring TBTC sites and IRB/IEC are compliant with Federal Wide Assurance and applicable human subjects regulations. Continuous confirmation that clinical site staff have appropriate documentation proficiency in GCP, HSP and investigator responsibilities, Organization and provision of site training, Development and implementation of a risk-based monitoring plan, detailed communication plan, clinical site quality management program and clinical site quality checks, Development and maintenance of a system to monitor clinical site items requiring expiration dates, Performance of protocol-specific on-site clinical monitoring at site and remote monitoring, Conduct/Management of routine and close-out visits on-site and at pharmacies and laboratories as applicable, Develop and maintain screening, recruitment, retention, pharmacy and regulatory compliance/quality management plans, Continuous review of performance at various sites, Coordination and management of investigational product shipments , delivery, proper storage thereof and inventory at clinical sites as well as accountability thereof and Utilization of an existing clinical trial management system in performance of associated monitoring services. �� Report to Sponsor and document findings during or following each on-site monitoring visit with clinical research sites as follows: Communicate urgent issues or questions arising during on-site visits to appropriate officials, Draft and share high-level, structured summary of visit findings, �draft monitoring reports, final monitoring reports, �and monitoring follow-up report (highlighting resolution and/or resolution or corrective action of deficiencies noted) in a timely fashion, Document participant-specific findings in TBTC2 study management system during site-visits, Reply to requests for clarification from summary e-mails or monitoring reports, Maintain log of findings from site visits, Provide resolutions of findings and Maintain log of participant charts reviewed in CRB-specified format. Draft and submit to Sponsor monthly reports of remote monitoring interactions with clinical research sites, and Draft and submit to Sponsor quarterly high-level, cumulative, summary reports of monitoring findings and pending follow-up log item, with site-specific assessments of study implementation and recommendations for Sponsor�s action.� Conduct Internal Quality Assurance and Audits and develop, implement and maintain internal Quality Assurance, Quality Control and Audit Plans. Conduct Investigational Product Management, identifying and establishing contractual agreements with clinical research vendor to support studies. �The contract will include the following requirements: Contractor must have a minimum of 5 years� experience monitoring ten or more tuberculosis or other infectious disease clinical trials simultaneously. This experience must be comparable to the complexity of work described herein. Contractors must respond to all the following points, by indicating your experience and ability to provide: Demonstrate 5 years of experience conducting clinical monitoring for the same volume simultaneously, type, and complexity as outlined herein. Demonstrate understanding of requirements and ability to travel amongst up to seventeen implementing clinical sites (convened simultaneously and located domestically and internationally), research pharmacies, and PK analysis laboratories to perform the type and caliber of services as outlined herein. � Demonstrate understanding of requirements to and overall experience and ability to travel to various sites (clinical sites, research pharmacies, PK analysis laboratories) and conduct monitoring services as outlined herein of up to seventeen clinical research sites (up to twelve (12) domestically and up to five (5) internationally) simultaneously that include planning, pre-study and TBTC specific activities in areas of high TB prevalence and incidence. Demonstrate an understanding of requirements for and the ability to comprehend, observe and review the management of clinical research sites to ensure: Sites are operating in compliance with approved protocol(s), Good Clinical Practice (GPC), Good Clinical Laboratory Practice (GCLP), Human Subjects Projection (HSP), and all applicable regulatory and local requirements while providing management and monitoring of clinical research sites; IRB/IEC are in compliance with Federal Wide Assurance (FWA) and applicable human subjects regulations, including review of all participant consent forms and of timeliness of local IRB reviews; and Clinical site staff have documentation of proficiency in GCP, HSP, and Investigator responsibilities. Demonstrate an understanding of requirements for and ability to comprehend, observe and review the management of clinical sites to ensure clinical site staff have documentation of proficiency in:� GCP, HSP, and Investigator responsibilities. Demonstrate prior experience reporting to/current ability to report to Sponsor findings, during and/or following each on-site monitoring visit with clinical research sites. Demonstrate understanding of associated requirements, experience in and ability to perform internal quality assurance, quality control and audit of clinical research sites . Demonstrate experience and ability to utilize TBTC2 or similar type web-based application system for data management of TBTC clinical research studies. Teaming Arrangements:� All teaming arrangements shall�include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email to Contracting Officer, Mrs. Candice L. Simmons at iie3@cdc.gov . �Responses shall be limited to 8 pages. CAPABILITY STATEMENTS MUST DEMONSTRATE THE MINIMUM REQUIREMENTS OUTLINED ABOVE.� Please address each in order listed above. Responses must be submitted not later than March 20, 2020 Capability statements will not be returned and will not be accepted after the due date. This is not an invitation for bid, request for proposal or other solicitation and in no way obligates CDC to award a contract.� The sole intent�of this Sources Sought Notice is to obtain capabilities for set-aside and procurement planning purposes.� Please provide the follow Business information:� DUNS Number Company Name Company Address. Company Point of Contact, phone number and email address Type of company under NAICS, as validated via the System for Award Management (SAM).� Additional information on NAICS codes can be found at www.sba.gov. �Any potential government contract must be registered in SAM located at http://www.sam.gov.�� Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); Current GSA Schedules appropriate to this Sources Sought Current Government Wide Agency Contracts (GWACs) Point of Contact, phone number and email address of individuals who can verify�the demonstrated capabilities identified in the responses. Responders should also include a statement about whether or not they have an approved Federal audited accounting system.� If the responder has an approved accounting system, please provide the certification in which the accounting system was deemed adequate (e.g. the name of the audit agency and audit number).� You may submit as an attachment, which will not count towards the overall page limit. �[1] Binkin NJ, Vernon AA, Simone PM, et al. Tuberculosis prevention and control activities in the United States: an overview of the organization of tuberculosis services. Int J Tuberc Lung Dis. 1999;3:663-74. [2] Benator D, Bhattacharya M, Bozeman L, et al., and the Tuberculosis Trials Consortium. Rifapentine and isoniazid once a week versus rifampicin and isoniazid twice a week for treatment of drug-susceptible pulmonary tuberculosis in HIV-negative patients: a randomized clinical trial. Lancet. 2002;360:528-34
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/d10eeaf8f9c94b6eaa2dfbac78b4405d/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05581550-F 20200307/200305230152 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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