NIH Awards $34.8M Clinical Trials Monitoring Service Contract to Theradex Systems, Inc

Contract Overview

Contract Amount: $34,785,582 ($34.8M)

Contractor: Theradex Systems, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2022-05-01

End Date: 2026-04-30

Contract Duration: 1,460 days

Daily Burn Rate: $23.8K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: CLINICAL TRIALS MONITORING SERVICE

Place of Performance

Location: PRINCETON, MIDDLESEX County, NEW JERSEY, 08540

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $34.8 million to THERADEX SYSTEMS, INC. for work described as: CLINICAL TRIALS MONITORING SERVICE Key points: 1. Contract awarded to Theradex Systems, Inc. for clinical trials monitoring. 2. The contract is valued at $34.8 million over its duration. 3. Competition was full and open after exclusion of sources. 4. The sector is Research and Development in Physical, Engineering, and Life Sciences. 5. The contract type is Cost Plus Fixed Fee.

Value Assessment

Rating: fair

The Cost Plus Fixed Fee (CPFF) contract type can lead to cost overruns if not managed carefully. Benchmarking CPFF contracts in R&D is challenging due to unique project scopes.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition after exclusion of sources, suggesting a competitive process. However, the specific reason for exclusion needs further review to ensure maximum price discovery.

Taxpayer Impact: Taxpayer funds are being used for essential clinical trial monitoring, which supports medical research. The CPFF structure requires diligent oversight to ensure cost-effectiveness.

Public Impact

Supports critical medical research by ensuring the integrity of clinical trials. Potential for advancements in physical, engineering, and life sciences. Contract duration of approximately 4 years allows for sustained monitoring. Award to a single entity may concentrate expertise but limits broader market engagement.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Cost Plus Fixed Fee structure requires careful monitoring to control costs.
Potential for scope creep in R&D contracts.
Limited information on specific performance metrics and success criteria.

Positive Signals

Full and open competition after exclusion of sources indicates a structured procurement.
Contract supports vital research and development activities.
Long-term contract duration provides stability for monitoring services.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on physical, engineering, and life sciences. Spending in this area is crucial for innovation but often involves complex, long-term projects with variable costs.

Small Business Impact

The data does not indicate if small businesses were involved as subcontractors or partners in this contract. Further investigation would be needed to assess small business participation.

Oversight & Accountability

The Department of Health and Human Services, through NIH, is responsible for oversight. The CPFF structure necessitates robust financial and performance monitoring to ensure accountability and prevent waste.

Related Government Programs

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Cost Plus Fixed Fee contract type.
R&D sector often has inherent cost variability.
Potential for limited competition due to source exclusion.
Lack of explicit small business participation data.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $34.8 million to THERADEX SYSTEMS, INC.. CLINICAL TRIALS MONITORING SERVICE

Who is the contractor on this award?

The obligated recipient is THERADEX SYSTEMS, 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 $34.8 million.

What is the period of performance?

Start: 2022-05-01. End: 2026-04-30.

What specific criteria were used to exclude other sources during the full and open competition phase, and how did this impact the final price?

The exclusion of sources during a 'full and open' competition typically implies that certain pre-qualification criteria were met by the selected vendor, or that specific circumstances warranted limiting the pool. Understanding these criteria is vital to assess if the exclusion potentially limited price competition or if it was a necessary step for specialized services. The impact on price would depend on whether the excluded sources could have offered a more competitive bid.

How will the Cost Plus Fixed Fee structure be managed to mitigate risks of cost overruns and ensure value for taxpayer money in this R&D context?

Effective management of a CPFF contract involves rigorous oversight of direct costs, detailed justification for all expenses, and close monitoring of the fixed fee to ensure it remains commensurate with the effort. For R&D, establishing clear milestones and performance metrics is crucial. Regular audits and performance reviews by the agency are essential to control costs and ensure the contractor is delivering on the research objectives efficiently.

What are the key performance indicators (KPIs) for this clinical trials monitoring service, and how will their achievement be measured to ensure effectiveness?

Key performance indicators for clinical trials monitoring typically include adherence to protocols, data accuracy and integrity, timely reporting, regulatory compliance, and patient safety. Effectiveness will be measured through regular audits of trial data, review of monitoring reports, assessment of compliance with Good Clinical Practice (GCP) guidelines, and evaluation of the contractor's ability to identify and mitigate risks promptly. The agency's quality assurance team will likely play a significant role in this assessment.

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: 75N91021R00014

Offers Received: 1

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 4365 ROUTE 1 S STE 101, PRINCETON, NJ, 08540

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

Financial Breakdown

Contract Ceiling: $151,756,070

Exercised Options: $40,410,141

Current Obligation: $34,785,582

Actual Outlays: $31,919,320

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline