HHS awards $317M contract for clinical trial planning and execution to Technical Resources International, Inc

Contract Overview

Contract Amount: $317,148,294 ($317.1M)

Contractor: Technical Resources International, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-08-22

End Date: 2028-08-21

Contract Duration: 1,826 days

Daily Burn Rate: $173.7K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CLINICAL SERVICES NETWORK- CLINICAL TRIAL PLANNING AND EXECUTION

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20817

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $317.1 million to TECHNICAL RESOURCES INTERNATIONAL, INC. for work described as: CLINICAL SERVICES NETWORK- CLINICAL TRIAL PLANNING AND EXECUTION Key points: 1. Contract focuses on critical R&D in biotechnology, aiming to enhance preparedness and response capabilities. 2. Technical Resources International, Inc. is the sole awardee under a full and open competition. 3. The contract duration of 5 years suggests a significant, long-term need for these specialized services. 4. The award type is a Delivery Order, indicating it's part of a larger contract vehicle. 5. The contract's value is substantial, reflecting the complexity and importance of clinical trial support. 6. The use of Cost Plus Fixed Fee (CPFF) pricing indicates potential for cost overruns if not managed closely.

Value Assessment

Rating: good

The contract value of $317 million over five years for clinical trial planning and execution appears reasonable given the specialized nature of the services. Benchmarking against similar large-scale R&D contracts in biotechnology is challenging without more specific service details. However, the CPFF pricing structure necessitates close monitoring to ensure value for money, as it allows for costs to be reimbursed plus a fixed fee, which can sometimes lead to higher overall expenditures compared to fixed-price contracts if not managed effectively. The absence of specific performance metrics in the provided data makes a definitive value assessment difficult.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under a full and open competition, suggesting that multiple qualified bidders had the opportunity to submit proposals. The specific number of bidders is not provided, but a full and open competition generally fosters a competitive environment, which can lead to better pricing and innovation. The fact that Technical Resources International, Inc. was selected indicates they offered the best value proposition among the competing entities.

Taxpayer Impact: A full and open competition is generally favorable for taxpayers as it increases the likelihood of obtaining competitive pricing and ensures that the government explores a wide range of capabilities.

Public Impact

The primary beneficiaries are the Department of Health and Human Services (HHS) and the Office of Assistant Secretary for Preparedness and Response (ASPR), who will receive support for critical clinical trial activities. The services delivered will encompass planning and execution of clinical trials, crucial for developing new medical countermeasures and improving public health preparedness. The geographic impact is likely national, given the scope of federal health initiatives, though specific locations for trial execution are not detailed. Workforce implications include the potential for employment of scientists, researchers, project managers, and other specialized personnel within Technical Resources International, Inc. and its potential subcontractors.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The Cost Plus Fixed Fee (CPFF) contract type can incentivize contractors to incur more costs, as a portion of their profit is tied to the total cost.
Lack of specific performance metrics in the provided data makes it difficult to assess the contractor's performance and ensure accountability.
The duration of the contract (5 years) could lead to complacency if not actively managed and reviewed.
The absence of small business subcontracting information raises questions about opportunities for smaller firms in this large contract.

Positive Signals

Awarded through a full and open competition, indicating a robust selection process and potential for competitive pricing.
The contract supports critical R&D in biotechnology, aligning with national priorities for health security and preparedness.
Technical Resources International, Inc. is a single awardee, suggesting they possess specialized capabilities deemed essential for this complex task.
The contract is for a significant duration, implying a sustained commitment to advancing important research objectives.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, a critical area for advancing medical science and public health. The market for clinical trial services is substantial, driven by pharmaceutical companies, government agencies, and academic institutions. This contract with HHS's ASPR positions Technical Resources International, Inc. as a key player in supporting government-led initiatives for health preparedness and response, potentially involving novel therapeutics and vaccines. Comparable spending benchmarks are difficult to ascertain without more granular data on the specific types of trials and services required.

Small Business Impact

The provided data indicates that small business participation (ss: false, sb: false) was not a specific set-aside requirement for this contract. This suggests that the primary focus was on securing the most capable large business to fulfill the complex R&D needs. There is no explicit information on subcontracting plans for small businesses, which could represent missed opportunities for the small business ecosystem to participate in significant federal R&D funding. Future analysis could explore if the prime contractor has a history of subcontracting with small businesses.

Oversight & Accountability

Oversight for this contract will primarily reside with the Department of Health and Human Services (HHS) and specifically the Office of Assistant Secretary for Preparedness and Response (ASPR). As a Cost Plus Fixed Fee (CPFF) contract, rigorous financial oversight and auditing will be crucial to ensure that costs are reasonable and allocable, and that the fixed fee is earned appropriately. Transparency will depend on HHS's reporting practices regarding contract performance and expenditures. The Inspector General's office within HHS would have jurisdiction to investigate any potential fraud, waste, or abuse related to this contract.

Related Government Programs

Biotechnology Research and Development
Clinical Trial Management
Public Health Preparedness
Medical Countermeasures Development
Government R&D Contracts
Health and Human Services Contracts

Risk Flags

Cost Plus Fixed Fee (CPFF) pricing structure requires close monitoring for cost control.
Lack of specific performance metrics in provided data hinders performance assessment.
Potential for cost overruns inherent in CPFF contracts.
Limited information on small business subcontracting opportunities.
Contract duration of 5 years necessitates ongoing oversight to ensure continued value.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $317.1 million to TECHNICAL RESOURCES INTERNATIONAL, INC.. CLINICAL SERVICES NETWORK- CLINICAL TRIAL PLANNING AND EXECUTION

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 $317.1 million.

What is the period of performance?

Start: 2023-08-22. End: 2028-08-21.

What is the track record of Technical Resources International, Inc. in managing large-scale federal clinical trial contracts?

A comprehensive review of Technical Resources International, Inc.'s track record would involve examining their past performance on similar federal contracts, particularly those with HHS or other agencies involved in health R&D. This includes assessing their success in meeting timelines, budgets, and performance requirements. Data on contract awards, modifications, and any past performance evaluations or disputes would be crucial. Without specific historical data on their performance in managing large-scale clinical trial planning and execution, it is difficult to definitively assess their capabilities and reliability for this $317 million award. Further investigation into their contract history and client feedback would be necessary.

How does the $317 million contract value compare to similar federal investments in clinical trial planning and execution over the past five years?

Comparing the $317 million contract value requires identifying comparable federal contracts for clinical trial planning and execution. This would involve searching federal procurement databases for awards with similar scope, duration (5 years), and agency (e.g., HHS, DoD, NIH). Factors such as the specific therapeutic areas, complexity of trials (e.g., Phase I, II, III), and the inclusion of services like regulatory affairs, data management, and site monitoring would need to be considered. Preliminary analysis suggests that large, multi-year contracts for comprehensive clinical trial support can range from tens to hundreds of millions of dollars, making this award appear within a plausible, albeit high, range for significant federal initiatives. However, a precise benchmark requires a detailed comparison of service scope and market rates.

What are the primary risks associated with a Cost Plus Fixed Fee (CPFF) contract for clinical trial services, and how are they mitigated?

The primary risk with a CPFF contract is the potential for cost overruns, as the contractor is reimbursed for allowable costs plus a fixed fee. This can disincentivize cost control if not managed diligently. For clinical trial services, risks include unexpected scientific challenges, regulatory hurdles, patient recruitment difficulties, and unforeseen expenses in trial execution. Mitigation strategies typically involve robust government oversight, detailed cost accounting standards, regular audits, clear performance metrics, and strong contract management. The fixed fee component provides some incentive for efficiency, but the government must actively monitor expenditures and ensure that all costs are reasonable, allocable, and necessary to the contract's objectives. Clear definition of scope and deliverables is also critical.

What is the expected impact of this contract on the government's ability to respond to public health emergencies?

This contract is expected to significantly enhance the government's ability to respond to public health emergencies by strengthening the infrastructure for clinical trial planning and execution. By ensuring that specialized services are readily available through Technical Resources International, Inc., the Department of Health and Human Services (HHS) and the Office of Assistant Secretary for Preparedness and Response (ASPR) can more rapidly initiate and manage trials for new medical countermeasures, such as vaccines and therapeutics, during outbreaks or pandemics. This capability is crucial for accelerating the development and deployment of life-saving interventions, thereby improving national health security and reducing the impact of public health crises.

How has federal spending on clinical trial support services evolved over the last decade, and where does this contract fit in?

Federal spending on clinical trial support services has likely seen a steady increase over the last decade, driven by growing investments in biomedical research, national security initiatives (e.g., biodefense), and the increasing complexity of drug and vaccine development. Agencies like HHS (including NIH and ASPR), the Department of Defense, and the VA are major sources of funding. This $317 million contract for clinical trial planning and execution fits within the higher end of federal awards for such services, particularly for large-scale, multi-year initiatives aimed at preparedness and response. It reflects a strategic investment in building and maintaining critical capabilities rather than routine research, suggesting a focus on high-priority public health needs.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 6500 ROCK SPRING DR STE 650, 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: $317,148,294

Exercised Options: $317,148,294

Current Obligation: $317,148,294

Actual Outlays: $47,725,995

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50120D00018

IDV Type: IDC

Timeline