Posted: May 11, 2021, 11:11 a.m. EDT
Please see attached Amendment 4, revised answer to question #14.
The deadline for submitting questions has passed.
The RFP is attached for this solicitation.
Introduction
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Allergy, Immunology, and Transplantation has a requirement for a clinical site monitoring center.
Description
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical, and clinical research focusing on protective immune responses and immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to 1) evaluate the safety and efficacy of therapeutic and preventive approaches and agents, and 2) elucidate the underlying mechanisms of such approaches and agents.
A critical component of DAIT's awarded grants and contracts involves the design and conduct of clinical research studies, including Phase 1 through 4 clinical trials of investigational approaches, intended to lead to a functional state of immune tolerance in three main clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues, and cells.
Purpose and Objectives
The purpose of this acquisition is to:
- Provide an expanded, wide range of clinical site monitoring services for NIAID-funded clinical research/trials of immune-mediated diseases, including as examples the delivery of monitoring services for:
- the Immune Tolerance Network (ITN)
- Asthma and Allergic Diseases Clinical Research Programs:
- Asthma and Allergic Diseases Cooperative Research Centers (AADCRC)
- Atopic Dermatitis Research Network (ADRN)
- Consortium for Food Allergy Research (CoFAR)
- Inner City Asthma Consortium (ICAC), which is to be replaced in 2021 by the Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)
- Autoimmunity Centers of Excellence (ACE)
- Transplantation Clinical Research Programs:
- Clinical Trials in Organ Transplantation (CTOT) and in Children (CTOT-C), both of which will be replaced in Fiscal Year (FY) 2021 by the Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA)
- Non-network clinical research/trials on a limited, as-needed basis, and
- Unanticipated NIAID clinical research studies/trials that may be required in response to public health emergencies and/or emerging needs.
2. Advance the field of risk-based monitoring through innovation using novel and effective approaches, with the goal of ensuring participant safety, quality data, and greater site/study compliance.
Project requirements
The Contractor shall provide comprehensive clinical site and study monitoring services for a broad range of NIAID-sponsored and/or -funded clinical research (including but not limited to clinical trials) for both domestic and international research. The contractor will be responsible for:
- Clinical Site Monitoring System: Maintain a system to monitor domestic and international clinical research sites with respect to ensuring their adherence to regulatory requirements governing human subjects research, ICH E6(R2) Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), country- and state-specific requirements governing human subjects research, protocol-specific requirements, and NIAID policies and procedures;
- Training: Develop and implement training programs for clinical site personnel and site monitors;
- CSMC Data Management and Reporting System: Manage, maintain and update, as necessary, a centralized 21 CFR Part 11 compliant CSMC Data Management and Reporting System, using commercially available software, for the storage, quality control and retrieval of contract-generated data, reports and other materials, and for reporting on contract activities and the findings of the clinical site assessment and monitoring functions performed;
- Coordination and Collaboration with other NIAID Clinical Research Support Contractors and Grantees: At the direction of NIAID, the Contractor shall collaborate and coordinate with NIAID contractors, grantees, and partners on an as needed basis, in order to carry out clinical site and study monitoring and reporting responsibilities;
- Risk-Based Monitoring Innovation: At the direction of the COR, engage in the conduct of risk-based monitoring research that applies technological and effective solutions, with the goal of advancing strategic approaches that improve efficiencies in process and outcomes, with the outcome of increased participant safety, quality data and greater site/study compliance;
- Quality Assurance and Quality Control: Develop and implement a Quality Assurance/Quality Control (QA/QC) Plan designed to: (i) standardize contract processes; (ii) ensure that the conduct of all contract activities complies with domestic and country-specific regulations governing human subjects research, ICH GCP guidelines, and NIAID policies and procedures; and (iii) provide for the assessment of Contractor performance and the quality of clinical site monitoring activities conducted;
- Clinical, Scientific and Technical Personnel: The Contractor shall provide a Principal Investigator (PI)/Project Director with responsibility for overall project management and communications, tracking performance and cost, and monitoring and reporting on project status and progress. The PI/Project Director will ensure that the clinical, scientific, and technical personnel have the relevant individual education, training, expertise, experience, and qualifications required for the successful completion of contract requirements;
- Facilities, Equipment and Other Resources: The Contractor shall provide all facilities, equipment and other resources necessary to carry out the requirements of the contract.
Posted: May 10, 2021, 5:31 p.m. EDT
Posted: April 23, 2021, 11:35 a.m. EDT
Posted: April 7, 2021, 3:59 p.m. EDT
Posted: Feb. 23, 2021, 6:10 p.m. EST
Background
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under the Department of Health and Human Services (DHHS), is dedicated to advancing research in microbiology and immunology. The agency's mission includes developing vaccines, therapeutics, and medical diagnostics aimed at preventing, treating, and diagnosing infectious and immune-mediated diseases.
The NIAID Division of Allergy, Immunology, and Transplantation has identified a need for a clinical site monitoring center to support its research initiatives.
Work Details
The contractor will provide comprehensive clinical site monitoring services for NIAID-funded clinical research related to immune-mediated diseases. Key tasks include:
1) Maintaining a Clinical Site Monitoring System to ensure compliance with regulatory requirements;
2) Developing training programs for clinical site personnel;
3) Managing a centralized CSMC Data Management and Reporting System compliant with 21 CFR Part 11;
4) Collaborating with other NIAID contractors and grantees as needed;
5) Conducting risk-based monitoring research to enhance participant safety and data quality;
6) Implementing a Quality Assurance/Quality Control Plan to standardize processes and ensure compliance with regulations;
7) Providing a Principal Investigator/Project Director for project management;
8) Supplying all necessary facilities, equipment, and resources for contract execution.
Place of Performance
The contract will be performed at both domestic and international clinical research sites.
