Inactive

This notice is being amended to advise the release date for the solicitation associated with this notice is now anticipated to be on or around June 8, 2020. Pre-solicitation Notice for Tuberculosis Tr... This notice is being amended to advise the release date for the solicitation associated with this notice is now anticipated to be on or around June 8, 2020. Pre-solicitation Notice for Tuberculosis Trials Consortium Monitoring Services This pre-solicitation notice is to advise of pending release of a solicitation for provision of TBTC monitoring services for a five-year period of performance and to be conducted on the Tuberculosis Trials Consortium Clinical Trials which will be conducted over the course of a 10-year period of performance. The service code associated with the requirement will be R499 (Support-Professional: Other Support-Professional). A description of the types of services anticipated under the pending solicitation are as follows: The purpose of proposed monitoring services is to provide monitoring and other support of the clinical trials and clinical research performed by the TBTC throughout a five-year performance period 2020 -2025. During this time the TBTC network will place emphasis on studies of latent TB infection in low- and medium- TB incidence settings, inclusive of but not limited to the United States and Canada, as well as studies of active TB disease both domestically and internationally. Awarded clinical site contractor(s) 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 associated with proposed monitoring services 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 to ensure clinical trial quality and participant safety, adherence to U.S. and international standards of good clinical practice, data collection and reporting, regulatory compliance, accurate protocol implementation, internal quality management and study product accountability. As this trial is conducted under IND, has the potential to be audited by US Food & Drug Administration and/or European Medicines Agency. The following will be required: On-site initiation visits for all participating sites prior to first enrollment; On-site periodic monitoring visits; On-site close out visits; Tracking of monitoring activities and deficiencies; and Reports of monitoring findings. To support the on-site monitoring, the DCC team will provide: Access to and training for the TBTC2 study management system; Protocol and case report form training; Guidance on protocol implementation; Input into study monitoring plan incorporating principles of risk-based monitoring; Documentation of obligations transferred from sponsor to CRO; Central monitoring of study data and activities; Quality assurance of study data; and Pre-site visit reports and information prioritizing tasks at on-site visits. Tasks will include the following: Planning, Pre-Study, and TBTC-Specific Activities TBTC Clinical Site Management and Monitoring Reporting to Sponsor And Internal Quality Assurance and Audits Monitoring Services shall involve the following (This is not all-inclusive): The Conduct of 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; 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; Development and maintenance of 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. Additionally, Reporting to sponsor(s) 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 Fmparticipant-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 as needed. Vendor shall, as an independent organization and not as an agent of the Government, furnish all the necessary services, qualified personnel, material, equipment, and facilities necessary to concurrently conduct monitoring activities for and at multiple clinical trials and/or study sites for the TBTC. The following is a detailed description of the number of studies, in addition to three pre-existing studies, the TBTC is estimating will be introduced for the Base Year and first four 1-year option periods for which monitoring services will be required: BASE YEAR The vendor shall perform start-up/preparation activities in accordance with the procedures and guidelines outlined in detail in the enclosed examples of a Phase 2 clinical trial, a Phase 3 clinical trial, and/or a pharmacokinetic protocol. Examples of protocols for TBTC Studies are provide as Attachments in Section J. Enrollment into a study may not begin until the relevant ethical committees or Institutional Review Boards (IRBs) have granted approval. Upon IRB approval the vendor shall start the enrollment, treatment, testing, follow-up, observation, data collection, specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that new studies may be initiated during this phase. OPTION PERIOD 1: The vendor shall start or continue the enrollment, treatment, testing, follow-up, observation, data collection, specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION PERIOD 2: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION PERIOD 3: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-2 new studies may be initiated during this phase. OPTION PERIOD 4: The vendor shall start or continue the enrollment, treatment, follow-up, observation, data collection, and specimen collection, and compliance activities for the studies chosen to be implemented. The government estimates that 0-4 new studies may be initiated during this phase. While a solicitation number is still to be determined, it is estimated that a solicitation will be issued to secure these services on or around June 1, 2020. The anticipated award date associated with this anticipated solicitation is estimated to be September 2020. Additional detail or items to be determined are as follows: Proposed Solicitation Number – TBD Closing Response Date – 3:00 pm EST on May 22, 2020 Contract Award and Solicitation Number – TBD Contract Award Dollar Amount -TBD Line Item Number – TBD Contractor(s) – TBD Place of Contract Performance – TBD Set-aside Status: None National Stock Number (NSN) if assigned – N/A Specification and whether an offeror, its product, or service must meet a qualification requirement in order to be eligible for award, and identification of the office from which additional information about the qualification requirement may be obtained (see subpart 9.2) - TBD Manufacturer, including part number, drawing number, etc. – N/A Size, dimensions, or other form fit or functional description. – N/A Predominant material of manufacture – N/A Quantity, including any options for additional quantities. – N/A Unit of issue – 1 Job Destination information – TBD Delivery schedule – TBD Sustainable acquisition requirements (or a description of high-performance sustainable building practices required, if for design, construction, renovation, repair, or deconstruction) (see parts 23 or 36). – TBD The NAICS code associated with this requirement is 541690, “Other Scientific and Technical Consulting Services”. The associated size standard is $16.5 Million. Point of Contact: Contracting Officer: Candice L. Simmons at iie3@cdc.gov or (770) 488-1432 Centers for Disease Control and Prevention (CDC) 2939 Brandywine Rd (MS-K15), Atlanta, GA 30341. All inquiries regarding this Pre-Solicitation notice must be received electronically at iie3@cdc.gov with subject line titled “Tuberculosis Trials Consortium Monitoring Services “ no later than 05/13/2020. Telephonic and US mail inquiries will not be accepted. **Please note the government’s requirement as stated herein is subject to change before release of pending solicitation. If and at such time a solicitation is released it may or may not reflect the same verbiage/information herein. The primary purpose of this notice is to advise of potential pending release of a solicitation for Tuberculosis Trials Consortium Services.** ** This is not an official Request for Proposal**