HHS awards $74.5M for CRO assistance, with a significant portion for pandemic preparedness

Contract Overview

Contract Amount: $74,513,740 ($74.5M)

Contractor: Technical Resources International, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2020-08-17

End Date: 2023-12-31

Contract Duration: 1,231 days

Daily Burn Rate: $60.5K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 3

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CRO ASSISTANCE FOR THE ACTIV-1 MASTER PROTOCOL

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20817

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $74.5 million to TECHNICAL RESOURCES INTERNATIONAL, INC. for work described as: CRO ASSISTANCE FOR THE ACTIV-1 MASTER PROTOCOL Key points: 1. Contract value represents a substantial investment in critical research and development capabilities. 2. The contract's duration suggests a long-term commitment to supporting the specified protocol. 3. Competition dynamics are crucial for ensuring cost-effectiveness in R&D services. 4. Performance context is tied to the specific needs of the ACTIV-1 Master Protocol. 5. Sector positioning is within the vital biotechnology research and development landscape. 6. Risk indicators may include scientific uncertainty and the evolving nature of public health threats.

Value Assessment

Rating: good

The contract value of $74.5 million over approximately four years appears reasonable for specialized CRO services supporting a complex research protocol. Benchmarking against similar large-scale clinical trial support contracts would provide a more precise value-for-money assessment. The Cost Plus Fixed Fee (CPFF) pricing structure allows for flexibility but requires careful monitoring of costs to ensure efficiency.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple qualified bidders had the opportunity to submit proposals. This competitive process is generally expected to yield favorable pricing and innovative solutions. The presence of three bidders suggests a healthy level of interest and capability within the market for these specialized services.

Taxpayer Impact: Full and open competition typically benefits taxpayers by driving down costs through market forces and encouraging a wider pool of contractors to vie for government work.

Public Impact

The primary beneficiaries are public health initiatives and the advancement of medical research, specifically related to the ACTIV-1 Master Protocol. Services delivered include critical support for clinical trial management and research operations. The geographic impact is primarily focused on the research and development sector, with potential downstream benefits for public health nationwide. Workforce implications include the employment of skilled scientific, research, and administrative personnel within the contracting organization.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in CPFF contracts if not rigorously managed.
Dependence on a single contractor for critical research support could pose a risk if performance falters.
The evolving nature of research protocols may necessitate contract modifications, impacting budget and timeline.

Positive Signals

Awarded through full and open competition, suggesting a robust selection process.
Contract duration indicates a stable and predictable support structure for the research protocol.
Focus on a specific, critical research protocol (ACTIV-1) demonstrates targeted investment in public health priorities.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, a critical area for advancing medical treatments and public health preparedness. The market for Contract Research Organizations (CROs) supporting clinical trials is substantial, with significant government spending directed towards pharmaceutical and biomedical research. This award aligns with broader federal investments in life sciences and pandemic response capabilities.

Small Business Impact

The contract data indicates that small business participation was not a primary set-aside consideration for this award (ss: false, sb: false). While this specific contract may not directly benefit small businesses through a set-aside, the prime contractor, TECHNICAL RESOURCES INTERNATIONAL, INC., may engage small businesses for subcontracting opportunities. The overall impact on the small business ecosystem would depend on the extent of any subcontracting arrangements and the nature of those services.

Oversight & Accountability

Oversight for this contract would primarily reside with the Department of Health and Human Services (HHS), specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). Mechanisms likely include regular performance reviews, financial audits, and adherence to the terms of the Cost Plus Fixed Fee agreement. Transparency is generally maintained through contract databases and reporting requirements, though specific operational details may be proprietary.

Related Government Programs

National Institutes of Health (NIH) Research Grants
Biomedical Advanced Research and Development Authority (BARDA) Contracts
Centers for Disease Control and Prevention (CDC) Public Health Initiatives
Department of Defense (DoD) Medical Research Programs

Risk Flags

Potential for cost overruns in CPFF contract.
Reliance on contractor for critical research support.
Evolving nature of R&D protocols may impact scope and timeline.
Need for robust government oversight to ensure value and efficiency.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $74.5 million to TECHNICAL RESOURCES INTERNATIONAL, INC.. CRO ASSISTANCE FOR THE ACTIV-1 MASTER PROTOCOL

Who is the contractor on this award?

The obligated recipient is TECHNICAL RESOURCES INTERNATIONAL, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $74.5 million.

What is the period of performance?

Start: 2020-08-17. End: 2023-12-31.

What is the specific nature of the 'ACTIV-1 Master Protocol' and why is it critical for HHS?

The ACTIV-1 Master Protocol is a critical initiative under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership led by the National Institutes of Health (NIH) and the Foundation for the NIH. Its purpose is to streamline and accelerate the development of effective COVID-19 treatments and vaccines. This master protocol allows for the simultaneous testing of multiple investigational drugs and vaccines in a standardized framework, enabling faster evaluation of promising candidates. HHS, through agencies like ASPR, funds and supports such critical research to ensure the nation has the tools necessary to combat public health emergencies like the COVID-19 pandemic. The $74.5 million award directly supports the operational and logistical needs of this vital research effort.

How does the Cost Plus Fixed Fee (CPFF) pricing structure compare to other contract types for R&D services?

The Cost Plus Fixed Fee (CPFF) contract type is common for research and development (R&D) efforts where the scope of work can be uncertain or evolve significantly. In a CPFF contract, the government reimburses the contractor for all allowable costs incurred, plus a predetermined fixed fee representing profit. This differs from fixed-price contracts, where the price is set upfront, and cost-reimbursement contracts (like Cost Plus Incentive Fee or Cost Plus Award Fee) which may include performance incentives. For R&D, CPFF offers flexibility to adapt to unforeseen challenges and discoveries, which is beneficial when the exact path to success is unknown. However, it places a greater emphasis on robust government oversight to control costs and ensure the fixed fee remains appropriate for the effort expended.

What are the key performance indicators (KPIs) likely being used to evaluate TECHNICAL RESOURCES INTERNATIONAL, INC.'s performance?

Key performance indicators (KPIs) for a contract supporting a master protocol like ACTIV-1 would likely focus on several critical areas. These could include adherence to study timelines and milestones, quality of data generated (accuracy, completeness, timeliness), compliance with Good Clinical Practice (GCP) and regulatory requirements, effective management of clinical sites and investigators, efficient patient recruitment and retention rates, and overall project management effectiveness. Financial performance, such as managing costs within the approved budget and efficient use of resources, would also be closely monitored. The fixed fee component of the CPFF contract incentivizes the contractor to meet these performance expectations efficiently.

What is the historical spending trend for similar CRO services by HHS or other agencies?

HHS, particularly through agencies like the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), has significantly increased its spending on Contract Research Organizations (CROs) and related services, especially since the onset of the COVID-19 pandemic. This $74.5 million award is part of a broader trend of substantial federal investment in accelerating medical countermeasures and clinical research. Historically, spending in this area has fluctuated based on public health priorities and the emergence of new threats. However, the recent focus on pandemic preparedness and response has led to a sustained increase in demand and funding for CRO services across various federal agencies, including the Department of Defense (DoD) for medical research.

What are the potential risks associated with the contractor's track record or the nature of the R&D work?

Assessing the specific track record of TECHNICAL RESOURCES INTERNATIONAL, INC. would require a deeper dive into their past performance on similar government contracts, including any past performance evaluations or disputes. However, general risks associated with R&D contracts of this nature include scientific uncertainty (the research may not yield the desired results), regulatory hurdles (delays in approvals or changes in requirements), and the potential for scope creep if the protocol evolves significantly. For a CPFF contract, there's also the risk of cost overruns if not managed diligently by both the contractor and the government oversight team. The complexity of a master protocol also introduces risks related to coordination among multiple sites and research arms.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: RTOR-2020-01

Offers Received: 3

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 6500 ROCK SPRING DR, BETHESDA, MD, 20817

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Hispanic American Owned Business, Minority Owned Business, Small Business, Special Designations, U.S.-Owned Business, Woman Owned Business

Financial Breakdown

Contract Ceiling: $74,513,740

Exercised Options: $74,513,740

Current Obligation: $74,513,740

Actual Outlays: $74,265,587

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Parent Contract

Parent Award PIID: HHSO100201400002I

IDV Type: IDC

Timeline