United States - NIAID/Division of AIDS: Regulatory Support Center

Description

Added: Apr 03, 2019 7:22 am

Anticipated Period of Performance
The anticipated period of performance is October 15, 2019 through April 14, 2020, with four term options to extend services for an additional 12 month period per option, starting on April 15, 2020, through April 14, 2024 (if all term options are exercised)

Anticipated award date: October 15, 2019
Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The mission of Division of AIDS (DAIDS), NIAID, is to bring an end to the HIV/AIDS epidemic by increasing the basic knowledge of the pathogenesis and transmission of HIV, to support the advancement of therapies for HIV infection and its complications, and to support the development of HIV/AIDS vaccines and other prevention measures. NIAID/DAIDS, henceforth referred to as DAIDS, supports extramural Clinical Trials Networks, investigator-initiated clinical trials, and partners with other Government and private organizations, in order to accomplish DAIDS's scientific objectives. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines, and other preventive modalities.
The DAIDS global clinical trial portfolio includes approximately 440 active protocols, 73 active INDs, 300+ network study sites in 22 countries, and collaborations with 60 pharmaceutical companies. This contract provides comprehensive clinical regulatory support services for all DAIDS-supported network and non-network clinical trials. As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP).
Description
In order to provide regulatory support services for the aforementioned DAIDS clinical trials portfolio, a restricted competition (small business set-aside) was held, which resulted in the award of a contract (Contract No. HHSN272201700014C) to Technical Resources International (TRI), Inc., 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817, for the "NIAID/Division of AIDS: Regulatory Support Center". A cost-plus-award fee, term form contract was awarded on April 15, 2017, to deliver 48.45 full time equivalents (FTEs) per year, with term options to extend the period of performance, for a total period of seven years, through April 14, 2024, and quantity options for increased level of effort for unanticipated increases in demand. The total value of the contract is $79,104,240 including the Base Period and all Options.
This contract provides regulatory expertise and support to operate and manage the NIAID/Division of AIDS (DAIDS) Regulatory Support Center (RSC), to provide a wide range of clinical research activities and programs for DAIDS, including the delivery of regulatory support services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies. The DAIDS RSC provides comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international clinical trial research; 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the DAIDS Enterprise System (DAIDS-ES) and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.
The contract was awarded based on the assumptions that the Contractor would be providing regulatory support services in compliance with the current regulatory requirements existing at that time. However, since the award of the contract in April 2017, data from many of the clinical trials are now being submitted as part of marketing applications, to both the U.S. Food and Drug Administration (FDA) and other regulatory authorities around the world [e.g., the EMA, and the South African Health Products Regulatory Authority (SAHPRA)], which requires that DAIDS be compliant with requirements for multiple regulatory agencies. Further, DAIDS is required to address any current and future findings resulting from regulatory agency inspections for all submitted clinical trials, in order ensure that DAIDS meets all current as well as evolving national, international, ICH-GCP, and country-specific regulatory requirements. Finally, the number of pending and on-going clinical trials has increased by more than was expected from the time the solicitation for this contract award was published. The foregoing has led to an increase in the volume of regulatory support services required, which has resulted in the need to increase the number of FTEs that will be needed to carry out work under the contract over the next 4.5 years (see Project Requirements below).
The purpose of this acquisition is to increase the quantity of FTEs to be delivered to the Government through the remainder of the current contract, beginning on October 15, 2019 of Option 2/Contract Year 3, thereby increasing the effort available to support the increase in volume of regulatory support services required. These additional regulatory support resources are needed, in order to: provide regulatory support services in compliance with regulatory requirements for multiple regulatory agencies, which have evolved since the award of the contract; address current and future regulatory findings, in order to be in compliance with evolving requirements from the various regulatory agencies; and support an increase in the number of submissions to regulatory authorities. These additional needs are compounded by the increase in number of pending and on-going clinical trials for which regulatory support services are required.
Specifically, the Contractor will be responsible for the following activities: 1) Assisting with the development of SOPs, quality assurance quality control plans, training, meetings with Health Authorities; 2) Reviewing documents for regulatory compliance and preparing and filing new regulatory submissions (such as INDs); 3) Safety and Pharmacovigilance activities including safety reporting; 4) Database and website operation and maintenance; 5) Tracking all protocol registration materials; 6) Maintaining clinical and study related information in the NIAID Clinical Research Management system; 7) Assisting with preparing, negotiating, and finalizing Clinical Trial Agreements; 8) Assisting with human subjects protection related issues and ClinicalTrials.gov requirements; and 9) Assisting with technical regulatory and administrative review of clinical documents (such as protocols and consent forms).
Specifically, the Contractor will be responsible for the following additional activities:
1. Establish a fully validated, centralized electronic Trial Master File (eTMF) for clinical trial protocols funded by DAIDS/for which DAIDS is Sponsor.
2. Conduct two-way safety data reconciliation with the Data Management Centers.
3. Support pharmacovigilance activities, to include trend analysis and signal detection, using advanced analytics.
4. Support DAIDS's compliance as study product manufacturer and regulatory Sponsor.
5. Provide technical and administrative support services for DAIDS policies and inspection-related activities.
The NIAID intends to negotiate, under the authority of FAR Part 6.302-1 and HHSAR Part 306.302-1, on a sole source basis with Technical Resources International, Inc., to modify the existing contract to provide an increase to the required Level of Effort under the base requirement (Options 2-6) of the current contract as follows:
• An increase of 18 FTEs (from 48.45 FTEs to 66.45 FTEs) in Option 2/Year 3 (beginning October 15, 2019)
• An increase of 13 FTEs (from 48.45 FTEs to 61.45 FTEs) in Option 3/Year 4
• An increase of 16 FTEs (from 48.45 FTEs to 64.45 FTEs) in Option 4/Year 5
• An increase of 16 FTEs (from 48.45 FTEs to 64.45 FTEs) in Option 5/Year 6
• An increase of 15 FTEs (from 48.45 FTEs to 63.45 FTEs) in Option 6/Year 7
A Total Increase of 78 FTEs (Options 2-6/Contract Years 3-7)
Due to the complex nature of DAIDS clinical trial operations and the need for a contractor to work within the existing DAIDS regulatory framework, multiple DAIDS and Clinical Trial Network systems, regulatory authorities and other internal and external stakeholders named above, this work can only be completed using the current contractor. Attempting to bring in a new contractor would result in a significant disruption to critical regulatory support services, would delay DAIDS remediation efforts and CAPA responses to recent EMA inspection findings, and would postpone additional pending regulatory authority submissions. If a new contractor, with no institutional history, no established relationships, no established processes, and no experience/operational knowledge base was required to integrate its activities, de novo, into this existing, highly complicated, regulatory support network, there would be an immediate fracturing of these already established systems/processes/ communication pathways. Additionally, due to the tight integration of current system requirements, the introduction of a new contractor would impose a significant disruption to even existing operations. Any impedance/disruption would, in turn, jeopardize the continuation of the affected clinical trials; impact the rights, safety and well-being of the clinical trial subjects; and diminish the quality and integrity of the clinical trial data. Using the current contractor for the additional services allows for the critical continuity of operations in this highly regulated environment and helps to ensure that DAIDS is able to meet its regulatory obligations for its clinical trials.
This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement. All capability statements received within fifteen days from the date of the publication of this notice will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
This proposed acquisition was previously published under a Research and Development Sources Sought Notice that was posted on the Federal Business Opportunities website on March 15, 2019 as notice number HHS-NIH-NIAID-RDSS-75N93019R00013.

Opportunity closing date

17 April 2019

Value of contract

to be confirmed