Attachment_1_-_Statement_of_Work.pdf

Statement of Work (SOW) Research and Development (R&D)

Research Support Services (Clinical and Scientific)

1. Background and Purpose

The National Institutes of Health (NIH) requires services to support its clinical and scientific research and development (R&D) mission. This requirement supports the National Plan to End Parkinson's. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Neurological Disorders and Stroke (NINDS) are combining requirements under this contract to achieve operational efficiencies, realize economies of scale, and reduce duplication of effort while supporting complementary and intersecting research portfolios.

Other Institutes with similar needs may also be able to access.

By consolidating these requirements, NIH seeks to leverage shared expertise, promote consistent and high-quality support within and across Institutes, and enhance coordination for activities that benefit from cross-Institute collaboration.

This contract is intended to enhance NIH’s ability to plan, coordinate, evaluate, and execute complex biomedical research initiatives while maintaining appropriate separation between Government decision-making and contractor support. The Contractor shall provide subject matter expertise with deep understanding of clinical and scientific research. This expertise includes methods for clinical quality improvement, including effective continuity of care across multi-disciplinary clinical care and patient support teams, analytical support for all aspects driving mission execution, operational efficiency, planning and coordination, as directed by the Government and in support of the Administration’s efficiency and stewardship goals, to support program offices and stakeholders. Specific focal areas include quality improvement, organizational structure and process development, regulatory compliance, and efficiency objectives in advancing scientific discovery, strengthening ethical oversight, and enabling effective and efficient clinical and scientific program implementation.

2. Scope of Work

The Contractor shall provide comprehensive services in support of NIH research and development (R&D) activities across multiple program areas across multiple Institutes, enabling each institute to leverage best practices. These services are intended to strengthen NIH’s capacity to plan, coordinate, evaluate, and execute complex biomedical research initiatives while maintaining appropriate separation between Government decision-making and contractor support functions.

The scope of work encompasses clinical, scientific, analytical, planning, and operational support activities that advance NIH’s mission, improve efficiency and stewardship, and support high-quality research and patient-centered clinical research programs. The Contractor shall bring subject matter expertise with a deep understanding of clinical quality, clinical research, translational science, and biomedical program operations, and shall apply this expertise in a manner consistent with NIH policies, applicable federal regulations, and established best practices.

2.1 Clinical and Scientific Support

The Contractor shall provide expert clinical and scientific support to NIH program offices and stakeholders, including but not limited to:

• Providing subject matter expertise to support evidence-based approaches to operations management, including improving clinical research operations, human subject and patient safety, and care delivery and operating models associated with NIH-supported research.

• Supporting clinical quality improvement initiatives, including efforts that promote effective continuity of care across multidisciplinary clinical care and patient support teams.

• Planning and conducting organizational assessments by collecting, analyzing, synthesizing, and interpreting data related to scientific, clinical research, and operational functioning.

• Prepare recommendations on program planning, efficiency strategies, evaluation criteria, and use of continuous improvement tools.

• Supporting the development, coordination, and documentation of clinical and scientific activities related to intramural and extramural research programs.

• Support administration, evaluate scientific programs, conduct analyses, and assist with guidance to grant applicants and recipients.

• Plan, organize, and coordinate highly complex and cross cutting projects in specialized topics.

• Generate reviews summarizing the research on the impact of disease, such as Parkinson’s disease and other neurodegenerative Parkinsonisms, and its effect on the physical, mental, and social health of individuals living with Parkinson’s and their caregivers and families.

• Developing materials necessary for Federal Advisory Councils to effectively evaluate the development of safe and effective treatments, strategies, and other approaches to prevent, diagnose, treat, and cure neurological disorders, ameliorate symptoms, and slow or stop progression

• Provide programmatic support related to NIH initiatives, including, but not limited to, legislative implementation activities associated with the National Plan to End Parkinson’s Act, to include stakeholder engagement and coordinating across internal and external stakeholders to support effective information exchange and program implementation.

2.2 Translational Research Program Support

The Contractor shall support translational research programs by:

• Assisting in the planning, coordination, and monitoring of research initiatives that bridge basic science, clinical research, and patient-focused outcomes.

• Supporting programmatic activities that enable efficient progression of research across the translational spectrum, including coordination among scientific, clinical, and administrative stakeholders.

• Providing analytical support to assess program performance, identify gaps or inefficiencies, and recommend process improvements aligned with NIH priorities.

• Providing senior strategic input and offering expert guidance to trans-NIH research programs focused on developing non-addictive pain therapeutics as alternatives to opioids, such as those covered under the NIH HEAL Initiative.

• Providing subject matter expertise for developing drug discovery and development strategy from early stages through FDA and other regulatory approval and clinical trials.

• Develop replicable methods for estimating the level of current Federal investment in preventing, diagnosing, treating, ameliorating symptoms, slowing or stopping progression, and curing disease, such as Parkinson’s disease and other neurodegenerative Parkinsonism’s.

2.3 Consolidation Support for Institutes to Gain Efficiencies

The Contractor shall provide analytical and operational support that advances mission execution, efficiency, and stewardship goals, including The Contractor shall provide change management services that strengthen oversight and regulatory compliance including:

• Developing change management strategies for the IC efforts at consolidating scientific, management and research administration in a multi-IC service center approach.

• Assisting with the preparation, tracking, and organization of materials related to programmatic, management and regulatory review, compliance requirements, and governance processes.

• Conducting analyses to support strategic and program planning, performance evaluation, and decision-support activities as directed by the Government.

• Supporting operational assessments and workflow analyses aimed at improving efficiency, coordination, and resource utilization across Institute programs.

• Assisting in the development of tools, reports, and documentation that support transparency, accountability, role clarity, and effective program management.

• Assisting with the execution of process improvement initiatives focused on clinical, research and research administration.

3. Tasks and Requirements

The Contractor shall perform the tasks described below to support NIH research and development (R&D) activities. All tasks shall be performed in accordance with NIH policies, applicable federal regulations, and established best practices, and shall maintain appropriate separation between Government decision-making and contractor support functions.

Task 1: Clinical and Scientific Support Services

The Contractor shall provide clinical and scientific support services to assist NIH staff in the planning, coordination, analysis, and evaluation of biomedical research and clinical programs.

Activities may include, but are not limited to:

• Providing subject matter expertise in the organization systems, processes, and operations underpinning biomedical, clinical, and translational research to support NIH program offices and leadership.

• Supporting clinical quality improvement initiatives, including efforts that promote continuity of care and coordination across multidisciplinary clinical care and patient support teams to enable cohesive functioning across organizational boundaries.

• Developing and leading organizational assessments that include collection, analysis, synthesis, and interpretation of data related to scientific, clinical research, and operational functioning. This work, in turn, informs program planning, efficiency, evaluation, and continuous improvement.

• Supporting the development, review, and coordination of clinical and scientific program materials related to intramural and extramural research activities.

• Providing analytical and documentation support to inform evidence-based approaches to clinical research operations, patient safety, and care delivery models associated with NIH-supported research.

• Facilitating coordination among intramural and extramural research stakeholders, while supporting Government-led decision-making processes.

Deliverables may include:

• Written analyses, summaries, and technical reports

• Briefing papers, organizational assessments, and presentation decks

• Program tracking tools, dashboards, and status updates

• Facilitation, agenda development, workshops, and change management services for individuals and teams engaged in quality improvement

Task 2: Translational Research Program Support

The Contractor shall provide programmatic, analytical, and operational support to translational research programs, including support to the NINDS Division of Translational Research (DTR), to advance research from discovery through clinical application.

Activities may include, but are not limited to:

• Supporting strategic planning, implementation, and coordination of translational research initiatives across the translational spectrum.

• Assisting with coordination among scientific, clinical, administrative, and external stakeholders to support efficient program execution.

• Developing and maintaining program documentation, schedules, milestones, and tracking mechanisms.

• Supporting the evaluation of program effectiveness, progress toward milestones, and research outcomes.

• Providing analytical support to identify gaps, inefficiencies, and opportunities for process improvement aligned with NIH priorities.

• Assisting with preparation of reports, briefings, and materials for NIH leadership, advisory bodies, and external audiences.

Deliverables may include:

• Program plans, timelines, and performance tracking reports

• Meeting summaries, action item logs, and coordination materials

• Strategic, programmatic, and operational briefing materials

Task 3: Consolidation Support Services

The Contractor shall provide analytical and operational support services to advance NIH mission execution, efficiency, and stewardship goals across clinical and research programs. The Contractor shall provide change management services to assist NIH in strengthening oversight and maintaining compliance with applicable laws, regulations, and standards by supporting institutes as they consolidate scientific, management and research administration services and pool resources to avoid duplication of efforts.

Activities may include, but are not limited to:

• Conducting analyses to support strategic and program planning, performance evaluation, and decision-support activities as directed by the Government.

• Supporting operational assessments, workflow analyses, and process improvement initiatives aimed at enhancing efficiency, coordination, and resource utilization.

• Assisting in the development reports and documentation that promote transparency, accountability, and effective clinical and scientific program management.

• Providing analytical support to assess operational risks, dependencies, and opportunities for improvement across programs.

• Supporting consolidation efforts by providing change management strategies and communication plans.

• Facilitating coordination among centralized staff, NIH program staff, and other stakeholders, while maintaining appropriate confidentiality and role separation.

Deliverables may include:

• Program summaries and analytical reports

• Briefing materials, training, guidance, and communication materials

• Analytical reports, performance assessments, and improvement recommendations

• Program management plans, tools, dashboards, and supporting documentation and artifacts

4. Deliverables and Reporting

The Contractor shall provide deliverables as specified under each task. All deliverables shall be submitted in formats specified by the Government and adhere to NIH standards for quality, accessibility, and confidentiality.

The Contractor shall provide regular status reports, as requested, to summarize progress, identify risks, and highlight upcoming activities.

5. Period of Performance

The period of performance shall be defined in the contract award and may include a base period and option periods.

6. Place of Performance

Work shall be performed remotely and/or at NIH facilities, as directed by the Government.

7. Government Furnished Information (GFI)

The Government may provide relevant equipment, background materials, policies, data, and access necessary for performance of this work.