NIH awards $61.4M contract for clinical trial support, with 2 bids received

Contract Overview

Contract Amount: $61,378,186 ($61.4M)

Contractor: Technical Resources International, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2021-07-01

End Date: 2026-06-30

Contract Duration: 1,825 days

Daily Burn Rate: $33.6K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: PURPOSE: TO PROVIDE CLINICAL TRIALS SPONSOR AND REGULATORY MANAGEMENT SUPPORT SERVICES TO THE NCI, THE CENTER FOR CANCER RESEARCH (CCR), AND CCR INVESTIGATORS.

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20817

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $61.4 million to TECHNICAL RESOURCES INTERNATIONAL, INC. for work described as: PURPOSE: TO PROVIDE CLINICAL TRIALS SPONSOR AND REGULATORY MANAGEMENT SUPPORT SERVICES TO THE NCI, THE CENTER FOR CANCER RESEARCH (CCR), AND CCR INVESTIGATORS. Key points: 1. Contract provides essential support for cancer research clinical trials. 2. Competition level suggests potential for price discovery, though only two bids were submitted. 3. Contract type is Cost Plus Fixed Fee, which can incentivize cost control. 4. Performance period spans over five years, indicating a long-term need. 5. The contract is a definitive contract, suggesting a well-defined scope of work. 6. Small business participation is not explicitly mandated by this award.

Value Assessment

Rating: good

The contract value of $61.4 million over five years averages approximately $12.3 million annually. Benchmarking against similar contracts for clinical trial support services is challenging without more specific service details. However, the Cost Plus Fixed Fee (CPFF) structure, while common for R&D, requires careful monitoring to ensure costs remain reasonable and that the fixed fee adequately compensates the contractor for their effort without excessive profit. The number of bids received (2) is on the lower side for a contract of this value, which could indicate less competitive pricing than if more bidders had participated.

Cost Per Unit: N/A

Competition Analysis

Competition Level: limited

This contract was awarded under 'Full and Open Competition After Exclusion of Sources,' which implies that while full and open competition was intended, specific circumstances led to the exclusion of certain potential sources. With only two bids received, the level of competition was limited. This could mean that the pool of qualified contractors is small, or that other factors deterred additional bidders. Limited competition can sometimes lead to higher prices than would be achieved in a more robustly competed environment.

Taxpayer Impact: With only two bidders, taxpayers may not have benefited from the full range of competitive pricing that a larger pool of offerors could have provided. The agency should ensure that the pricing negotiated is still fair and reasonable given the limited options.

Public Impact

Patients participating in NCI-CCR clinical trials will benefit from streamlined regulatory and sponsor management. Cancer researchers at the NCI's Center for Cancer Research will receive enhanced support for their studies. The contract supports critical research activities aimed at advancing cancer treatment and understanding. The primary geographic impact is within the National Institutes of Health's research facilities, likely in Maryland. The contract supports specialized scientific and administrative roles within the research ecosystem.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited competition may result in less favorable pricing for the government.
The CPFF contract type requires robust oversight to prevent cost overruns.
The specific reasons for excluding sources in the 'full and open competition after exclusion of sources' award need further clarification to ensure fairness.

Positive Signals

The contract supports critical cancer research, aligning with national health priorities.
The five-year duration provides stability for essential research support services.
The contractor, Technical Resources International, Inc., has a track record in supporting government research initiatives.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. The North American Industry Classification System (NAICS) code 541715 covers Research and Development in the Physical, Engineering, and Life Sciences. This is a significant area of federal spending, particularly within agencies like NIH, dedicated to advancing scientific knowledge and developing new treatments. The market for clinical trial support services is specialized, involving a mix of scientific expertise, regulatory knowledge, and project management capabilities.

Small Business Impact

The data indicates that small business participation was not a specific set-aside for this contract (ss: false, sb: false). While the prime contractor is Technical Resources International, Inc., the subcontracting plan and its impact on small businesses are not detailed in the provided information. Agencies are encouraged to promote small business participation, and it's possible that the prime contractor will utilize small businesses for certain aspects of the support services, but this is not explicitly stated as a requirement or outcome of this award.

Oversight & Accountability

Oversight for this contract will be managed by the National Institutes of Health (NIH), a component of the Department of Health and Human Services. As a Cost Plus Fixed Fee contract, rigorous financial oversight and performance monitoring will be crucial to ensure that costs are reasonable and that the contractor meets all performance objectives. The contract's duration and value suggest that regular reporting and review mechanisms are likely in place. The specific Inspector General for HHS would have jurisdiction over potential fraud, waste, or abuse related to this funding.

Related Government Programs

National Cancer Institute (NCI) Research Support Contracts
Center for Cancer Research (CCR) Operations
Clinical Trials Management Services
Biomedical Research and Development Contracts
NIH Extramural Research Support

Risk Flags

Limited Competition
Cost Plus Fixed Fee Contract Type
Potential for Unjustified Source Exclusion

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $61.4 million to TECHNICAL RESOURCES INTERNATIONAL, INC.. PURPOSE: TO PROVIDE CLINICAL TRIALS SPONSOR AND REGULATORY MANAGEMENT SUPPORT SERVICES TO THE NCI, THE CENTER FOR CANCER RESEARCH (CCR), AND CCR INVESTIGATORS.

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 (National Institutes of Health).

What is the total obligated amount?

The obligated amount is $61.4 million.

What is the period of performance?

Start: 2021-07-01. End: 2026-06-30.

What is the specific nature of the 'clinical trials sponsor and regulatory management support services' being provided?

The provided data indicates the purpose is to offer 'Clinical Trials Sponsor and Regulatory Management Support Services to the NCI, the Center for Cancer Research (CCR), and CCR Investigators.' While the exact breakdown of services is not detailed, this typically encompasses a range of activities crucial for the successful execution of clinical trials. These can include protocol development assistance, regulatory submission preparation and management (e.g., to the FDA), data management and analysis support, patient recruitment and retention strategies, site monitoring, safety reporting, and overall project management to ensure trials adhere to ethical guidelines and regulatory requirements. The 'sponsor' aspect implies the contractor may assist in managing the trial as if they were the sponsor, or provide support to the NCI as the sponsor.

How does the pricing structure (Cost Plus Fixed Fee) compare to other contract types for similar services?

Cost Plus Fixed Fee (CPFF) contracts are common in research and development settings where the scope of work may evolve or is not precisely defined at the outset. In a CPFF contract, the government reimburses the contractor for allowable costs incurred, plus a predetermined fixed fee representing profit. This structure incentivizes the contractor to control costs, as the fee remains constant regardless of the final cost. Compared to Cost Plus Incentive Fee (CPIF) contracts, CPFF offers less direct incentive for cost reduction beyond avoiding disallowed costs. It differs from Firm-Fixed-Price (FFP) contracts, where the contractor bears the risk of cost overruns, often leading to higher initial pricing to account for that risk. For R&D services like clinical trial support, CPFF can be appropriate when innovation and flexibility are paramount, but it necessitates strong government oversight to manage costs effectively.

What are the potential risks associated with a 'Full and Open Competition After Exclusion of Sources' award?

The 'Full and Open Competition After Exclusion of Sources' designation suggests that while the solicitation was intended to be open to all responsible sources, specific criteria or circumstances led to the exclusion of some potential bidders. This could arise from unique capabilities required, proprietary information, or specific national security concerns, among other reasons. The primary risk for the government is a potentially reduced competitive landscape, which could lead to less favorable pricing and fewer innovative solutions compared to a truly open competition. It also raises questions about the transparency and fairness of the exclusion process. Ensuring that the exclusion was justified, well-documented, and that the remaining competition was robust is critical to mitigating these risks and demonstrating value for taxpayer money.

What is the historical spending pattern for similar clinical trial support services at NIH or NCI?

Without access to specific historical spending databases or detailed contract histories for NIH/NCI, it's difficult to provide precise historical spending patterns for these exact services. However, it is well-established that the National Institutes of Health, and particularly the National Cancer Institute, are major funders of biomedical research, including extensive clinical trials. Consequently, spending on support services for these trials, encompassing regulatory affairs, data management, and operational support, represents a significant and consistent portion of their overall budget. Annual spending can fluctuate based on research priorities, new initiatives, and the lifecycle of ongoing trials. The $61.4 million awarded here over five years suggests a substantial, ongoing need for such specialized support within the NCI's Center for Cancer Research.

What is the track record of Technical Resources International, Inc. in performing similar government contracts?

Technical Resources International, Inc. (TRI) has a history of performing contracts for various U.S. government agencies, including those within the health and research sectors. While the specific details of their past performance on contracts directly comparable to this NIH award are not provided in the summary data, TRI's general profile suggests experience in areas relevant to scientific and technical support services. A thorough review of their contract history, including past performance evaluations (e.g., CPARS reports), would be necessary to fully assess their track record, including their ability to manage costs, meet deadlines, and deliver quality services on similar projects. Their presence as a bidder and awardee on this significant NIH contract implies they possess the necessary qualifications and experience.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

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

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 75N91020R00027

Offers Received: 2

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: $115,518,487

Exercised Options: $61,378,186

Current Obligation: $61,378,186

Actual Outlays: $50,851,185

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline