The mission of the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is to increase the 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. 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. DAIDS has designed, developed and sponsored extramural Clinical Trial Networks, supported investigator-initiated clinical trials, and partnered with other Government and private organizations, in order to accomplish the Division's scientific objectives.
As the Investigational New Drug (IND) Application Sponsor for a large number of NIAID/DAIDS-funded clinical trials, NIAID/DAIDS is required to monitor clinical trials, in order to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312 and Human Subjects Protection Title 45 CFR Part 46. Clinical trials are also monitored in accordance with the E6 International Conference on Harmonisation Good Clinical Practices (ICH/GCP).
The Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has an existing contract (Contract No. HHSN272201700004C) for "NIAID Clinical Site Monitoring," with PPD Development, LP (PPD).
This contract was awarded on a competitive basis, for a seven-year period, from February 1, 2017 through January 31, 2024, with the purpose of providing comprehensive clinical site and study monitoring services for the NIAID/DAIDS clinical trial research portfolio, including the delivery of monitoring services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies. A term type/level of effort contract was awarded for the delivery of 62 Full Time Equivalents (FTEs) per year. The total value of the contract, including all options, is $127,236,253, and the contract includes options for the extension of the term (term options) for a total performance period of 7 years, and quantity options for increases in the level of effort. The contract was awarded based on the assumptions available at that time that the Contractor would be providing monitoring services for 150 clinical trials in over 17 countries at over 110 domestic and international clinical research sites. At this time, however, the requirement for monitoring services has increased and we are performing monitoring visits to 300 domestic and international sites that are conducting 158 clinical trial protocols. There are also 25 clinical trials, which will require monitoring that are pending implementation. The number of clinical trials in the pipeline for implementation fluctuates as protocol teams develop new studies. This increase in the amount of monitoring services 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 5 years.
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 (through January 31, 2024), beginning with the next term option [Option 2 (February 1, 2019 through January 31, 2020)], thereby increasing the effort available to support the monitoring for the increase in the number of clinical research sites, domestic and international, and the number of pending and on-going trials that has increased.
Specifically, the Contractor will be responsible for the following:
1. Conduct site initiation visits prior to clinical trial implementation to ensure compliance with DAIDS, U.S., and, where appropriate, country-specific regulatory requirements and guidelines.
2. Conduct routine site monitoring visits for active clinical trials to ensure compliance with DAIDS, U.S. and where appropriate, country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements.
3. Conduct specialized site monitoring visits for a variety of purposes, including regulatory audits, assessments of overall and protocol-specific research pharmacy operations and management of investigational products, and remedial or for cause site visits to implement and ensure adherence to corrective actions required to address site or study deficiencies identified through routine site monitoring.
4. Conduct site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products.
5. Prepare written reports on all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial/corrective actions.
6. Develop and implement Standard Operating Procedures for the conduct of clinical site monitoring functions, including the components to be reviewed/assessed and the processes to be used for each type of site visit.
7. Communicate and coordinate clinical site and study monitoring activities and data generated through these activities with other DAIDS clinical research support contractors and HIV/AIDS Clinical Trials Network components.
8. Develop and implement a Quality Assurance/Quality Control (QA/QC) Plan to ensure the efficient and effective performance of monitoring functions and the appropriate management of the project.
9. Remotely interact with various NIAID systems such as the NIAID-Clinical Research Management System (N-CRMS).
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 PPD, to modify the existing contract to provide an increase to the required Level of Effort by 20 FTEs/year, for Options 2-6 (Years 3-7) of the current contract. Due to the complex nature of DAIDS clinical trial operations and the need for a contractor to work within multiple DAIDS and Clinical Trial Network systems, 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 services and could jeopardize participant safety and data integrity. Data from a number of DAIDS-sponsored clinical trials are being used in the regulatory submissions for marketing applications for new drug approvals. In many cases, the application will trigger a regulatory agency inspection and increased scrutiny of the nature and extent of site/study monitoring that we conducted. Using the current contractor for the additional services allows for continuity of operations in this highly regulated environment and helps to ensure we are able to meet our regulatory obligations for adequately monitoring our 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 May 15, 2018 as notice number HHS-NIH-NIAID-RDSS-18-NIHAI2018014.
Deadline: Thursday, June 28, 2018
Date Published: Thursday, June 14, 2018
Date Updated: Thursday, June 14, 2018
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