Tuberculosis Trials Consortium

Tuberculosis Trials Consortium (TBTC) 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/conduct clinical trials and clinical research on the treatment, diagnosis and prevention of tuberculosis (TB) over a ten year period of performance both domestically and internationally. 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 contractors to conduct all phases of clinical trials in patients with TB disease or latent TB infection, including (as needed) screening, diagnosis, enrollment, treatment, observation, clinical testing, data collection, and follow-up after treatment. The scope of activities may range from small laboratory-based and/or single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens, diagnostics, and preventive interventions. Contractors shall also participate fully as members of the TBTC. Describe the work: The NAICS code associated with this requirement is 541714, “Research and Technology in Biotechnology (Except Nanobiotechnology)”. The associated size standard is 1,000 employees. Furnish all necessary services, qualified personnel, material, equipment, and facilities to conduct several clinical trials simultaneously. Contractor shall conduct all phases of clinical trials in patients with TB disease or latent TB infection, including (as needed) screening, diagnosis, enrollment, treatment, observation, clinical testing, data collection, and follow-up after treatment. The scope of activities may range from small laboratory-based and/or single site studies to large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs and drug regimens, diagnostics, and preventive interventions. Conduct all work under the infrastructure of the TBTC, which currently includes: A network of domestic and international clinical sites funded through direct contracts with CDC, through sub-contracts established by academic medical centers in North America with funding from the CDC, or through the VAMC IAA; CRB-guided study design, implementation, data and information management, microbiology lab oversight, regulatory affairs, and data analysis, with engagement and collaboration from vendor research sites. By-Laws which govern the function of the consortium, and which define a network of committees, protocol teams and working groups to facilitate the accomplishment of the consortium’s objectives; A communications system that includes extensive use of E-mail, teleconferences and web-conferences; and regular in-person meetings in Atlanta; Cooperative relationships with local clinics and TB control programs at recruiting sites, which facilitate the recruitment and management of trial participants; An expert Data & Safety Monitoring Board (DSMB) which convenes at least annually to review ongoing clinical trials; Coordination with and between the CDC Institutional Review Board (IRB) and IRBs from the clinical sites; Support for a contract research organization (CRO), which performs on-site clinical monitoring; A custom-designed web-based study management system (herein referred to as TBTC2), including electronic enrollment and data capture, tracking of regulatory approvals, real-time quality assurance, and drug supply management. Additional details of TBTC2 are: TBTC2 is custom designed and built by CDC staff and contractors solely for TBTC study management; TBTC2 is housed on CDC servers and accessible to all users via a secure URL; A user-role access matrix is implemented such that specific users are granted access only to modules within TBTC2 required for specific tasks; User access and credentialing is managed by CDC staff; and TBTC2 is optimized for computer use on Internet Explorer v11 but can be accessed via other internet browsers and mobile applications via the secure URL. There is not a mobile application for TBTC2. Cooperative relationships with: Key manufacturers of anti-TB drugs; Key public-private partnerships, non-governmental organizations, and international agencies; Mycobacteriology, pharmacology, pharmacokinetic, and genetics laboratories within and outside CDC; and The U.S. National Institutes of Health Collaborative relationships with global experts in TB clinical trials, medical statistics, pharmacology, animal modeling, basic mycobacteriologic science, and other domains. The contract will include the following requirements: Contractor must have a minimum of 10 years’ experience conducting clinical trials of 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 10 years of experience conducting, simultaneously, multiple clinical trials on TBTC or other infectious disease and of the same complexity of work described herein. Demonstrate understanding of requirements and ability to participate in multiple clinical research studies simultaneously to include: Clinicial trial planning and execution; Conducting research studies and/or clinical trials in accordance with established protocols; Recruitment as well as screening, provision of consent, enrolling and following participants of TBTC studies; Conducting and engaging in regulatory management; Recruiting appropriate types and quantities of personnel; Securing adequate types and quantities of laboratory facilities while maintaining proper certifications; Engaging in investigational product management; and Collection of, reporting of, review of, response too, utilization of and protection of study associated data and management thereof. Demonstrate understanding of requirements and ability to complete and adhere to start-up requirements within 60 days of contract award, with specific addenda for protocols, as applicable, and whenever site changes occur that impact these requirements to include the following: Development and submission of Study Plans for multiple studies simultaneously, specifically Pharmacy Plans, Regulatory Compliance and Quality Management Plans, and Recruitment, Screening, and Retention Plan; Observe and abide by regulatory requirements to include submission of IRB packages for registration, approvals and continuations, Submission of essential documents, Maintenance of delegation of authority log; and Provision for and ensurance that all clinical staff possess the appropriate education, training and experience documentation for their roles; Confirmed laboratory preparedness including: Sharing protocols and related materials with laboratory directors or site designated laboratories; Coordination between principle investigator, study coordinator, and laboratory director at time sites are informed of studies; and Laboratory Director confirmation that laboratory is prepared to participate. Participation in Drug Management Modules to place stock orders for study medication, confirm receipt of study medication, and document challenges with study drugs. Provide a description of the process for study drug importation and management and inform CRB of changes in the process (once known by sites) that would materially impact the site’s ability to timely and effectively import and manage study drugs. Reliable internet access must be maintained for Data Management. Request access to TBTC2 a web-based study management system. TBTC2, repository for site-specific information, must be reviewed for accuracy and updated for site-specific information as appropriate. Demonstrate an understanding of requirements for and the ability to participate fully as a member of the TB Trials Consortium (TBTC) throughout the duration of the contract to include attendance at all TBTC group meetings over the course of the 10-year period of performance. The primary purpose of these meetings will be to review progress and implementation of current trials, to learn from outside experts, conduct discussion about possible new studies, conduct discussions related to trial implementation, regulatory compliance and/or quality assurance. Meetings will be held up to twice a year and generally in Atlanta, GA. Demonstrate an understanding of requirements for and ability to provide clinical TBTC services over the course of the ten year period of performance whereas anywhere from (2) up to four (4) new studies could be added each year. 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 [email protected] . 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 26, 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. 10. 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