Notice Number: NOT-AI-16-023
Key Dates
Release Date: January 14, 2016. This RFP will be available electronically on/about January 15, 2016
None
Issued by
National Institute of Allergy and Infectious Diseases (NIAID)
Purpose
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. The National Institute of Allergy and Infectious Diseases, Division of Acquired Immunodeficiency Syndrome (DAIDS) supports the advancement of therapies for HIV infection and its complications, and supports 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. Currently, NIAID/DAIDS supports more than 150 clinical trials in over 17 countries, at more than 110 domestic and international clinical sites.
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). Over the past six years, approximately 90 monitors have performed more than 8,000 monitoring trips to over 200 clinical sites, in over 20 countries.
The purpose of the proposed contract will be to continue to provide 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.
The current NIAID/DAIDS Clinical Site Monitoring contract was awarded to Pharmaceutical Product Development, LLC, Wilmington, NC, on February 1, 2010, for a total period of seven years.
Project Requirements
Offerors should have the qualifications, experience and capability to perform this requirement. Specifically, the Contractor will be responsible for the following:
- 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.
- 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.
- 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.
- Conduct site closeout visits to ensure appropriate completion of clinical trials, storage of clinical records and disposition of investigational products.
- Prepare written reports on all site monitoring visits, including identification of problems and deficiencies and recommendations for remedial/corrective actions.
- 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.
- 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.
- 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.
- Ability to remotely interact with various NIAID systems such as the NIAID-Clinical Research Management System (N-CRMS).
Anticipated Period of Performance
It is anticipated that one (1) cost reimbursement, level-of-effort (term) type contract will be awarded. The period of performance will be for one (1) year (Base Period) plus six (6) one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about December 1, 2016. The requirement will be for the delivery of sixty-two (62) full time equivalents (FTEs) per year for the Base Period (Year 1) and sixty-two (62) FTEs per year for Options 1-6 (Years 2-7).
In addition, the Government may exercise options for an increased level of effort to support the following: (1) unanticipated increases in demand for the activities supported by the base requirements of this contract; and (2) the development or adaptation (including the maintenance of) a commercially available system, in order to implement site performance risk-based monitoring.
These Options are defined as follows:
Options 7-8, 10-11, 13-14, 16-17, 19-20, 22-23 and 25-26 Increased Level of Effort for Unanticipated Increases in Demand: During the course of the contract, it may be necessary to increase the level of effort, in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor’s activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional five (5) FTEs per option. Up to two options of this type may be exercised in any one year. The period of performance of an Option for Increased Services will not exceed the term of the Base year or Option year in which the Option is exercised.
Options 9, 12, 15, 18, 21, 24 and 27 Increased Level of Effort for Unanticipated Increases in Demand: During the course of the contract, it may be necessary to increase the level of effort, in order to support unanticipated increases in demand for the activities supported by the base requirements of the contract. Such an increase would require an increase in the Contractor’s activities, to be activated, at the discretion of the Government, as an Option. If the Government elects to exercise this Option, the Contractor shall provide an additional ten (10) FTEs per option. One option of this type may be exercised in any one year. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised.
Options 28 and 29, and 30-34 Increased Level of Effort for the Provision of a Site Performance Risk-Based Monitoring tool: During the course of the contract, it may be necessary to increase the level of effort in order to support the provision of a site performance risk-based monitoring tool. Such an increase would require an increase in the Contractor’s activities, to be activated, at the discretion of the Government, as an Option. The system should provide the ability to identify and weigh key risk factors that may have the greatest impact on participant safety and data integrity, ability to define threshold levels for risk factors and “flag” sites (i.e. green-yellow-red system) that fall outside of pre-determined levels for high, medium and low risk. In addition, the system should provide “real-time” reports, to allow for the identification of site quality and compliance risks, so that objective decisions can be made regarding frequency, degree, and type of monitoring visits (i.e., remote or on-site) for clinical research sites. The system should be flexible enough to accommodate any changes in business processes, and provide a variety of reports. Once developed and ready for production, the application will be hosted in the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) computing environment. The Contractor will communicate and collaborate with the OCICB, in order to determine the requirements for data transfer, to ensure compatibility with the OCICB computing environment.
Development Phase (Options 28-29): During contract years 2 and/or 3, the government may exercise options (Option 28 and/or 29), in order to support the development or adaptation of a commercially available system, in the N-CRMS or as a stand-alone system, in order to implement site performance risk-based monitoring (it is anticipated that the “development phase” should last approximately 1-2 years). Should the Government elect to exercise Option 28 and/or 29 (Development), the Contractor shall provide resources for the increase in work volume by two (2) FTEs for each option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised.
Maintenance Phase (Options 30-34): Beginning in contract year 3 or 4 (depending on when the development phase is complete) and through contract year 7, the system would be in a “maintenance phase”, and the government may exercise options (Options 30-34) to support this maintenance. Should the Government elect to exercise Options 30-34 (Maintenance), the Contractor shall provide resources for the increase in work volume by one (1) FTE for each option. The period of performance of an Option for Increased Services will not exceed the term of the Option year in which the Option is exercised.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on or about January 15, 2016, and may be accessed through FedBizOpps http://www.fedbizopps.gov/ and the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website https://ecps.nih.gov/NIAID and then click on "How to Submit."
Inquiries
Please direct all inquiries to:
Patrick Finn
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5401
Email: patrick.finn@nih.gov
John R. Manouelian
National Institute of Allergy & Infectious Diseases (NIAID)
Telephone: 240-669-5152
Email: manouelj@niaid.nih.gov
and Human Services (HHS)
