NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS)

Anticipated Period of Performance The anticipated period of performance is March 1, 2021 through May 31, 2022, with four options to extend services for an additional 12 period per option, through August 14, 2024 (if all term options are exercised) Anticipated award date: March 01, 2021 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 and laboratory 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). A contract for - NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS), was awarded as a result of a competitive solicitation to PPD Development, LP, 929 North Front Street, Wilmington, NC. A term type/level of effort contract was awarded for the delivery of 48.10 Full Time Equivalents (FTEs) per year. The total value of the contract, including all options, was $68,858,269, and the contract includes options for the extension of the term (term options) for a total performance period of 7 years from August 15, 2017 through August 14, 2024, and quantity options for increases in the level of effort during the term of the contract. The purpose of the contract is to provide a broad range of clinical and laboratory support services for all DAIDS-supported network and non-network clinical trials including serving as a gap-filling mechanism for unanticipated DAIDS clinical research projects. In July 2020, the contract was modified to procure full clinical trial support services for a sponsored DAIDS COVID-19 clinical trial entitled - A5401: Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID) also known as ACTIV- 2). This clinical trial is one of the studies supported by Operation Warp Speed (OWS) for the identification of a therapeutic for COVID-19. The support services provided to date include project management, medical writing, clinical site selection/feasibility/assessment/subcontracting, clinical data management, recruitment, clinical site activation/training, clinical site management support, medical monitoring and safety oversight support/call center, clinical site monitoring, electronic trial master file (eTMF), Quality Assurance/Control, laboratory services and provision of the final clinical study report. A total of 108.72 FTEs were added to the contract to address this COVID-19 requirement. The total value of the contract was also increased by $72,422,544 to cover performance from July 10, 2020 through June 30, 2021. At this time, both the complexity as well as quantity of requirements for full clinical trial support services for ACTIV- 2 have significantly increased based on - real time clinical trial implementation data as well as evolving scientific requirements. The numbers of sites, numbers of both screened and enrolled patients as well as remote monitoring requirements have all markedly increased. In addition, the period of the support needed has increased. Specifically, these significant increases of key clinical trial activity drivers include: Number of sites - over 346% increase in the number of Phase 2 sites (41 to 183) and over 317% increase in the number of Phase 3 sites (96 to 400); Number of screened patients - over 13% increase for Phase 2 screened patients (2,201 to 2,492) and over 57% increase in Phase 3 screened patients (8,901 to 14,000); Number of enrolled patients - over 33% increase for Phase 2 enrolled patients (1,320 to 1,760) and over 87% increase in Phase 3 enrolled/completed patients (5,340 to 10,000); Monitoring requirements - over 33% increase in Phase 2 monitoring requirements and over 67% increase in Phase 3 monitoring; The period of study is extended to May 31, 2022. Based on the increased requirements detailed above, the Government intends to negotiate under the authority of FAR Part 6.302-1 and HHSAR 306.302-1, on a sole source basis, with PPD Development, LP to modify the existing contract to provide 360 FTEs per year during the period March 1, 2021 through May 31, 2022 in order to provide the support needed for the completion of the ACTIV-2 study. Specifically, the Contractor will be responsible for continued support of the ACTIV-2 study by providing the following services: project management, medical writing, clinical site selection/feasibility/assessment/contracting, clinical data management, recruitment, clinical site activation/training, clinical site management support, medical monitoring and safety oversight support/call center, clinical site monitoring, electronic trial master file (eTMF), Quality Assurance/Control, laboratory services and provision of the final clinical study report. As stated in FAR Clause 6.302-1, full and open competition need not be provided for when there is only one responsible source and no other supplies or services will satisfy agency requirements. The current contractor, PPD Development, LP (PPD), is considered as the - only responsible source since attempting to bring in a new contractor into the ACTIV-2 clinical trial environment would result in a catastrophic disruption to the ACTIV-2 trial. Specifically, to attempt to integrate a different contractor into the ACTIV-2 trial environment would result in months, if not a year or more delay given the trial magnitude and complexity. Additionally, PPD has performed feasibility assessments of over 1300 sites, has qualified over 100 global sites and currently has over 68 active sites. Further, PPD has established agreements with investigators throughout the world and the ACTIV-2 trial is actively enrolling participants. PPD enrollment strategies have been fully vetted with DAIDS leadership and ACTIV-2 stakeholders and PPD's enrollment processes have been fully integrated within the existing DAIDS site management framework. PPD has also fully implemented and integrated its full clinical trial suite of processes within the DAIDS environment to insure that DAIDS is able to meet all regulatory requirements. Attempting to bring in a new contractor into the established ACTIV-2 clinical trial environment would represent a major interruption and delay to the ACTIV-2 trial. Such a disruption could not only jeopardize ACTIV-2 participant rights, safety and data integrity but would ultimately delay the availability of therapeutic modalities available for COVID-19. If there is a delay (even by a month) in continuing the ACTIV-2 trial, because we had to try to identify alternate sources, this scenario would likely result in further loss of life by depriving the nation of a therapeutic during an unprecedented pandemic. 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 SAM.gov website on November 3, 2020 as notice number HHS-NIH-NIAID-75N93021R00001.