Providing OMNIBUS IV Health & Medical Research Services to the DoD

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Contract Number HT001122D0026

A Streamlined Acquisition Option for DoD Science and Medical Research Missions

OMNIBUS IV is a $10 billion research and development contract vehicle that can be used across the DoD to enhance military health readiness, resilience, and rehabilitation. DoD customers can use the OMNIBUS IV to support R&D efforts, R&D Support Services, Regulatory Process Support, and Translational Science Support.

OMNIBUS IV Market Segments (MS)

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Knowesis offers Prime Services for OMNIBUS IV Research & Development Support Services (MS 2) and Translation Science Support Services (MS 4), and we provide subcontracted services for Research & Development (MS 1) and Regulatory Processes Support (MS 3). Knowesis scientific and technical subject matter expert consultants help the nation’s research institutions by advising, managing, and performing biomedical research to support the health of the American military and civilian populations. We deliver strategy development, portfolio and program management, process improvement, communications, and financial management services aligned with our clients’ practices. See detailed proficiency areas for these market segments listed below.

Steps to Add Work on the OMNIBUS IV

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Contract Overview

Program Office/Contract Number: Defense Health Agency, Contract Number HT001122D0026

Contract Type: Cost Plus Fixed Fee, Firm Fixed Price, Time and Materials, as determined by the Task Order Contracting Officer Representative

Contract Vehicle: Multiple Award Contract (MAC) Indefinite Delivery Indefinite Quantity (IDIQ)

Customers/Clients: DoD all relevant to SOW

Period of Performance: June 20, 2022 through June 19, 2027, option period June 20, 2027 through June 19, 2032

Place of Performance: Nationally and Worldwide

Funding/Classification/Clearance: Dependent on Task Order

Knowesis Points of Contact

Sheryl Cosing, Senior Associate, (703) 942-8560 x143, scosing@knowesis-inc.com

John Broughton, Director, Business Development, (202) 375-4911, jbroughton@knowesis-inc.com

Sheilah O’Brien, Managing Principal, (571) 348-0988, sobrien@knowesis-inc.com

OMNIBUS IV Proficiency Areas

Use OMNIBUS IV Task Orders to support DoD health and medical research needs in the four service areas or Market Segments (MS), as noted. Knowesis offers Prime Services for R&D Support (MS 2) and Translation Science Support (MS 4). We also provide subcontracted services for R&D (MS 1) and Regulatory Processes Support (MS 3). Call Knowesis POCs with any questions.

Market Segment 1: Research & Development

1. Research Collaborations: Types of work include DoD medical research with industry, commercial, university/scholarly, or other alliance.

2. Funding Continuum: Transition program funding to utilize RDT&E funds.

3. Maintain Standards: Support for compliance with quality, safety, security, and surety standards.

4. Regulatory Compliance: Work that includes supporting research outcomes and applying all Federal (e.g., HHS & FDA) and DoD regulations.

Market Segment 2: R&D Support Services

1. Administrative Services: Examples include administrative/clerical support, visual information, library services, program and financial analysis, and technology support, among others.

2. IT Services: Types of work include Information Technology (IT) and assurance engineering, IT application and help desk support, database administration, and IM/IT project management.

3. Scientific & Technical Services: Includes services such as laboratory technical support, veterinary pathology services, computer programming, biostatistics, data collection, management, and analysis.

4. Facilities Services: Examples include technical engineering and facilities quality assurance support.

5. Medical Services: Types of work include clinical and research protocols for Physicians, Psychologists, Physiologists, Biochemists, Toxicologists, Licensed Nurses, among others.

6. Supplies & Equipment: Examples include lifecycle support requirements for scalability, maintainabiity, supportability, and other requirements as appropriate for the specific initiative.

7. Logistical Services: Work such as training, medical readiness, management and operations, infrastructure, and biomedical support.

8. Other Task Order Support: Services include administrative, technical, informational products support, clinical trials and research volunteer support, among others.

Market Segment 3: Regulatory Processes

1. Animal Use & Vivaria: Includes services supporting compliance with DoD Instruction (DoDI) 3216.01, Use of Animals in DoD Conducted and Supported Research and Training, Animal Welfare Act, among others.

2. Human Research Subjects: Support ensuring compliance with DoDI 3216.61 Protection of Human Subjects and Adherence to Ethical Standards in DoD Conducted and Supported Research, Federal-Wide Assurance (FWA) terms.

3. Investigational Products: Includes services ensuring compliance with 10 USC 1107, DoDI 6200.02 - the Application of FDA Rules to DoD Force Health Protection Program, among others.

4. Device Requirements: Includes support ensuring compliance with CFR Title 21, (FDA), Investigational New Drug Application (21 CFR 312), Investigational Device Exemptions (21 CFR 812), and other FDA applications, approvals, and processes.

5. Federal Privacy Requirements: Services ensuring protections of Personally Identifiable Information (PII), Protected Health Information (PHI), Health Insurance, Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs, among others.

6. Technology Transfer: Supports preparation of documents and compliance regarding DoDI 5535.8, DoD Technology Transfer Program, Cooperative R&D Agreements (CRADAs), Education Partnership Agreements (EPAs), Knowledge Translation Agreements, among others.

Market Segment 4: Translational Science

1. Pre-Transition Support: Services include needs and gaps assessments, strategic analysis, transition plans and agreements.

2. Transition Support: Types of work include transition services and training, project management, transition, and equipment planning services, among others.

3. Evidence-Based Solutions: Examples include Clinical Practice Guidelines (CPGs), clinical decision support tools, policy, writing and language services, and more.

4. Dissemination Strategies: Examples include market research, environmental scans, health communication, product promotion, among others.

5. Implementation Strategies: Services include processes, evidence-based practices, public health education, change management, and effectiveness and behavioral change measures.

6. Evaluation Strategies: Types of work include evaluation methods and compliance, process and program evaluation, quantitative/qualitative analysis, among others.