HHS awards $330M contract for clinical trial planning and execution to ICON Government and Public Health Solutions

Contract Overview

Contract Amount: $330,226,484 ($330.2M)

Contractor: Icon Government and Public Health Solutions, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2023-08-22

End Date: 2025-04-11

Contract Duration: 598 days

Daily Burn Rate: $552.2K/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: HINCKLEY, MEDINA County, OHIO, 44233

State: Ohio Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $330.2 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC. for work described as: CLINICAL SERVICES NETWORK- CLINICAL TRIAL PLANNING AND EXECUTION Key points: 1. Contract focuses on critical clinical trial planning and execution services. 2. Awarded via full and open competition, suggesting a robust market. 3. Duration of 598 days indicates a medium-term project. 4. The contract type is Cost Plus Fixed Fee, which can incentivize cost control. 5. The specific NAICS code points to R&D in Biotechnology. 6. Geographic focus appears to be Ohio, based on the state abbreviation.

Value Assessment

Rating: good

The contract value of $330.2 million for clinical trial planning and execution over approximately two years appears reasonable given the scope. Benchmarking against similar large-scale clinical trial support contracts would provide a more precise value-for-money assessment. The Cost Plus Fixed Fee (CPFF) structure aims to balance cost control with contractor flexibility, but requires careful monitoring to ensure efficiency.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that multiple capable vendors were likely solicited. The number of bidders is not specified, but this method generally fosters competitive pricing and allows the government to select the best value. The open competition suggests a healthy market for these specialized services.

Taxpayer Impact: Taxpayers benefit from a competitive process that is designed to secure the most advantageous pricing and terms for the government, reducing the risk of overpayment.

Public Impact

The primary beneficiaries are public health initiatives requiring robust clinical trial support. Services delivered include planning, management, and execution of clinical trials. The contract has a geographic focus on Ohio. This contract supports the biomedical research and development workforce.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in CPFF contracts if not closely managed.
Ensuring timely delivery of critical clinical trial milestones is paramount.
The specific expertise required for complex clinical trials needs continuous validation.

Positive Signals

Awarded through full and open competition, indicating strong market interest and potential for best value.
The CPFF contract type can provide flexibility for evolving research needs.
The contract duration allows for comprehensive planning and execution of trial phases.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically NAICS code 541714. This sector is characterized by significant investment in innovation and requires specialized expertise for clinical trial management. The market size for clinical trial services is substantial, driven by pharmaceutical and biotechnology companies, as well as government health agencies. This award represents a significant investment by HHS in advancing public health research capabilities.

Small Business Impact

The data indicates this contract was not set aside for small businesses, nor does it explicitly mention subcontracting goals for small businesses. This suggests the primary awardee is likely a large business. Further analysis would be needed to determine if subcontracting opportunities exist for small businesses within the scope of this large contract, which could impact the small business ecosystem.

Oversight & Accountability

Oversight will likely be managed by the Office of Assistant Secretary for Preparedness and Response (ASPR) within HHS. Accountability measures will be tied to the Cost Plus Fixed Fee contract terms, performance metrics, and delivery schedules. Transparency will depend on HHS's reporting practices for this contract and any associated public health outcomes.

Related Government Programs

Biomedical Advanced Research and Development Authority (BARDA) contracts
National Institutes of Health (NIH) research grants
Centers for Disease Control and Prevention (CDC) public health initiatives

Risk Flags

Potential for cost overruns in CPFF contracts.
Ensuring timely delivery of critical research milestones.
Adequacy of government oversight for cost reasonableness.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $330.2 million to ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, INC.. CLINICAL SERVICES NETWORK- CLINICAL TRIAL PLANNING AND EXECUTION

Who is the contractor on this award?

The obligated recipient is ICON GOVERNMENT AND PUBLIC HEALTH SOLUTIONS, 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 $330.2 million.

What is the period of performance?

Start: 2023-08-22. End: 2025-04-11.

What is the track record of ICON Government and Public Health Solutions, Inc. in managing large-scale clinical trials for government agencies?

ICON Government and Public Health Solutions, Inc. has a significant track record in providing clinical research services. As a subsidiary of ICON plc, a global CRO, they possess extensive experience in managing complex clinical trials across various therapeutic areas. Their government contracting history includes work with agencies like the National Institutes of Health (NIH) and the Department of Defense. Specific to public health preparedness, their expertise in rapid trial design and execution is crucial. A detailed review of past performance evaluations and contract close-outs would further illuminate their capabilities and reliability in fulfilling government requirements, particularly concerning adherence to timelines, budget management, and quality of data generated.

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

The Cost Plus Fixed Fee (CPFF) contract type is common for research and development efforts where the scope may evolve or specific costs are difficult to predict upfront. In a CPFF contract, the government reimburses the contractor for allowable costs plus a fixed fee representing profit. This differs from Fixed-Price contracts, where the price is set regardless of actual costs, and Cost-Reimbursement contracts (without a fixed fee), which can offer less incentive for cost control. For clinical trial execution, CPFF offers flexibility to adapt to unforeseen scientific challenges or changes in trial protocols, while the fixed fee provides a predictable profit margin for the contractor. However, it requires robust government oversight to ensure costs remain reasonable and that the contractor is not incentivized to incur unnecessary expenses.

What are the key performance indicators (KPIs) likely to be used to assess the success of this clinical trial execution contract?

Key performance indicators (KPIs) for this contract would likely focus on several critical areas. These would include the timely initiation and completion of trial phases, adherence to protocol timelines, and patient recruitment rates. Data quality and integrity, including the accuracy and completeness of case report forms and adverse event reporting, would be paramount. Budget performance, tracking actual costs against projected expenditures and managing the fixed fee effectively, is also crucial. Furthermore, compliance with regulatory requirements (e.g., FDA, ICH-GCP) and the successful submission of trial results would be key indicators of success. The government will likely monitor these KPIs through regular progress reports and performance reviews.

What is the historical spending trend for clinical trial planning and execution services by the Department of Health and Human Services?

Historical spending by the Department of Health and Human Services (HHS) on clinical trial planning and execution services has generally trended upwards, reflecting the increasing complexity and cost of drug and vaccine development, as well as a growing emphasis on public health preparedness. Agencies within HHS, such as the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), are significant funders of clinical research. While specific figures fluctuate year-to-year based on emerging health threats and research priorities, the overall investment in supporting and executing clinical trials remains a substantial component of HHS's budget. This $330 million award is indicative of the scale of investment required for critical public health initiatives.

What are the potential risks associated with a Cost Plus Fixed Fee contract for a long-duration R&D project?

Cost Plus Fixed Fee (CPFF) contracts, while offering flexibility, carry inherent risks, particularly for long-duration Research and Development (R&D) projects. A primary risk is the potential for cost escalation if the government's oversight is insufficient to scrutinize the necessity and reasonableness of incurred costs. Contractors might have less incentive to aggressively control costs compared to fixed-price arrangements, as all allowable expenses are reimbursed. For R&D, where outcomes can be uncertain, scope creep can lead to significant cost increases beyond initial estimates, even with a fixed fee. Ensuring the 'fixed' fee remains appropriate throughout the contract's life, especially if significant unforeseen challenges arise, requires careful negotiation and management. Additionally, defining 'allowable costs' and 'effort' precisely is critical to prevent disputes.

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: 1265 RIDGE RD STE A, HINCKLEY, OH, 44233

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Foreign Owned, Foreign-Owned and U.S.-Incorporated Business, Not Designated a Small Business, Special Designations

Financial Breakdown

Contract Ceiling: $330,226,484

Exercised Options: $330,226,484

Current Obligation: $330,226,484

Actual Outlays: $6,850,891

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75A50120D00017

IDV Type: IDC

Timeline