NIH awards $32.5M for clinical trials monitoring, with Theradex Systems Inc. securing the contract

Contract Overview

Contract Amount: $32,481,380 ($32.5M)

Contractor: Theradex Systems, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2017-05-01

End Date: 2022-04-30

Contract Duration: 1,825 days

Daily Burn Rate: $17.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 2

Pricing Type: COST PLUS FIXED FEE

Sector: Healthcare

Official Description: IGF::OT::IGF 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 $32.5 million to THERADEX SYSTEMS, INC. for work described as: IGF::OT::IGF CLINICAL TRIALS MONITORING SERVICE Key points: 1. The contract value of $32.5 million over five years suggests a significant investment in clinical trial oversight. 2. Full and open competition was utilized, indicating a broad market search for qualified vendors. 3. The contract type, Cost Plus Fixed Fee, allows for cost reimbursement plus a predetermined profit, which can be beneficial for complex projects but requires careful monitoring. 4. The duration of 1825 days (5 years) points to a long-term need for these services. 5. The North American Industry Classification System (NAICS) code 541990 categorizes this as 'All Other Professional, Scientific, and Technical Services,' a broad classification. 6. The contract was awarded to Theradex Systems, Inc., a single entity, highlighting the specialized nature of the services required. 7. The contract's value falls within a moderate range for specialized scientific services, but benchmarking against similar trials monitoring contracts is crucial for assessing value.

Value Assessment

Rating: fair

The contract value of approximately $32.5 million over five years for clinical trials monitoring services appears to be within a reasonable range for specialized scientific support. However, without specific details on the scope of work, the number of trials monitored, or the complexity of the services provided, a definitive value-for-money assessment is challenging. Benchmarking against similar contracts for clinical trial monitoring services, particularly those awarded by NIH or other health agencies, would be necessary to determine if the pricing is competitive and reflects efficient resource utilization. The Cost Plus Fixed Fee (CPFF) contract type means that costs are reimbursed, plus a fixed fee, which can lead to cost efficiencies if managed well, but also carries risks of cost overruns if not closely monitored.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under 'Full and Open Competition,' suggesting that the National Institutes of Health (NIH) sought proposals from all responsible sources. This approach typically aims to maximize competition and identify the best value. The fact that two bids were received indicates that while the competition was open, the specialized nature of clinical trial monitoring may limit the number of highly qualified bidders. A higher number of bidders generally leads to more competitive pricing and a wider range of innovative solutions.

Taxpayer Impact: Full and open competition is generally favorable for taxpayers as it increases the likelihood of obtaining services at competitive prices. However, with only two bids, the price discovery mechanism might be less robust than if there were a larger pool of interested and capable contractors.

Public Impact

The primary beneficiaries are the National Institutes of Health (NIH) and the broader medical research community, who receive essential support for conducting clinical trials. The services delivered are critical for ensuring the integrity, safety, and efficacy of clinical trials, which are fundamental to advancing medical knowledge and developing new treatments. The geographic impact is national, as NIH-funded research and clinical trials are conducted across the United States. The contract supports specialized scientific and technical expertise, potentially impacting the workforce in clinical research management and monitoring.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

The Cost Plus Fixed Fee (CPFF) contract type requires diligent oversight to ensure costs remain reasonable and the fixed fee is justified by the scope of work.
With only two bidders in a full and open competition, there's a potential risk that the market for these specialized services is concentrated, limiting future competitive opportunities.
The broad NAICS code (541990) makes it difficult to precisely benchmark against highly specialized competitors without more detailed service descriptions.

Positive Signals

The use of 'Full and Open Competition' indicates an effort to ensure a wide search for qualified contractors.
The five-year duration suggests a stable, long-term need for these critical clinical trial support services.
The contract is awarded to a specific entity, Theradex Systems, Inc., implying they possess the necessary qualifications and experience for this specialized role.

Sector Analysis

The contract falls within the Professional, Scientific, and Technical Services sector, specifically focusing on clinical trial monitoring. This is a critical sub-sector supporting the pharmaceutical and biotechnology industries, as well as government health research. The market for clinical trial services is substantial, driven by the ongoing need for drug and device development and regulatory compliance. Comparable spending benchmarks would typically be found within contracts awarded by agencies like the Food and Drug Administration (FDA) or other components of the Department of Health and Human Services (HHS) for similar research support functions.

Small Business Impact

The data indicates that this contract was not set aside for small businesses (ss: false, sb: false). Therefore, the primary contractor, Theradex Systems, Inc., is likely a larger entity. There is no explicit information regarding subcontracting plans for small businesses within this award. The impact on the small business ecosystem would depend on whether Theradex engages small businesses as subcontractors, which is not detailed in the provided data.

Oversight & Accountability

Oversight for this contract would primarily reside with the contracting officers and program managers within the National Institutes of Health (NIH). The Cost Plus Fixed Fee (CPFF) structure necessitates robust financial oversight to ensure that costs incurred are reasonable and allocable to the contract, and that the fixed fee is earned. Transparency would be enhanced through contract reporting mechanisms and potentially through public contract databases. Inspector General jurisdiction would apply if any fraud, waste, or abuse were suspected.

Related Government Programs

NIH Clinical Center
FDA Contract Services
HHS Research Support Contracts
National Center for Advancing Translational Sciences (NCATS) Programs
Biomedical Research and Development Contracts

Risk Flags

Potential for cost overruns due to CPFF structure
Limited competition (2 bidders) may impact price discovery
Broad NAICS code requires detailed scope review for benchmarking

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $32.5 million to THERADEX SYSTEMS, INC.. IGF::OT::IGF 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 $32.5 million.

What is the period of performance?

Start: 2017-05-01. End: 2022-04-30.

What is the specific scope of services provided under this contract, and how does it compare to industry standards for clinical trial monitoring?

The provided data indicates the contract is for 'IGF::OT::IGF CLINICAL TRIALS MONITORING SERVICE' under NAICS code 541990 (All Other Professional, Scientific, and Technical Services). While the specific scope is not detailed, clinical trial monitoring typically involves overseeing the conduct of clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures, and regulatory requirements. This includes site visits, data verification, safety monitoring, and ensuring compliance with Good Clinical Practice (GCP) guidelines. Industry standards often involve detailed protocols for monitoring frequency, data review processes, and risk-based approaches. A direct comparison would require access to the contract's Statement of Work (SOW) and benchmarking against similar monitoring contracts awarded by other health agencies or pharmaceutical companies, considering factors like the number and phase of trials monitored, therapeutic areas, and geographic reach.

How does the awarded amount of $32.5 million compare to historical spending on similar clinical trial monitoring services by the NIH or other federal agencies?

The awarded amount of $32.5 million over five years equates to an average annual value of approximately $6.5 million. To assess historical spending, one would need to analyze past contracts for clinical trial monitoring services awarded by the NIH and other relevant agencies like the FDA or CDC. This would involve searching federal procurement databases (e.g., FPDS-NG, SAM.gov) for similar NAICS codes and contract descriptions. Benchmarking would consider the duration, scope, and complexity of services. Without this comparative data, it's difficult to definitively state whether $32.5 million represents high, low, or average spending. However, for specialized scientific services supporting a large research institution like NIH, this figure appears to be within a plausible range, assuming a substantial volume of trials are being monitored.

What are the key performance indicators (KPIs) used to evaluate the performance of Theradex Systems, Inc. under this contract?

The provided data does not specify the Key Performance Indicators (KPIs) for this contract. However, typical KPIs for clinical trial monitoring services often include metrics related to data accuracy and completeness, adherence to trial protocols and timelines, compliance with regulatory requirements (e.g., GCP), timeliness of monitoring reports, and the effectiveness of issue resolution. Performance would likely be assessed through regular reviews by the NIH contracting officer's representative (COR), feedback from clinical trial investigators and study teams, and audits. The success of Theradex Systems, Inc. would be measured by their ability to ensure the integrity and reliability of the clinical trial data, thereby supporting the validity of research findings and the safety of trial participants.

Given the Cost Plus Fixed Fee (CPFF) contract type, what are the primary risks associated with cost overruns, and what oversight mechanisms are in place?

The primary risk with a Cost Plus Fixed Fee (CPFF) contract is that the contractor may incur costs higher than anticipated, even though their profit (the fixed fee) remains constant. This can occur due to inefficiencies, scope creep not properly managed, or unforeseen complexities in the work. While the government reimburses allowable costs, excessive costs reduce the overall value proposition. Oversight mechanisms are crucial. The NIH contracting officer and COR must diligently review all claimed costs for allowability, allocability, and reasonableness. Regular financial reviews, audits, and close monitoring of the contractor's progress against the Statement of Work (SOW) are essential. The fixed fee itself incentivizes the contractor to manage costs efficiently to maximize their return on investment, but this must be balanced with robust government oversight to prevent unnecessary expenditures.

What is the track record of Theradex Systems, Inc. in performing similar clinical trial monitoring services for the federal government?

The provided data indicates that Theradex Systems, Inc. was awarded this contract. To assess their track record, one would need to examine their past performance on federal contracts. This involves searching federal procurement databases (like SAM.gov or FPDS-NG) for previous awards to Theradex Systems, Inc., particularly for services related to clinical trial monitoring, research support, or scientific consulting. Information on past performance, including any past performance evaluations or awards/debarments, would provide insight into their reliability, quality of service, and adherence to contract terms. Without this historical data, it's difficult to comment on their specific track record with the federal government.

What is the potential impact of this contract on the broader landscape of clinical research and development within the United States?

This contract plays a role in supporting the NIH's mission to advance biomedical research. By ensuring robust monitoring of clinical trials, it contributes to the generation of reliable scientific data, which is essential for the development of new therapies and medical advancements. Reliable clinical trial data underpins regulatory approvals by agencies like the FDA and informs clinical practice. The contract's execution by Theradex Systems, Inc. contributes to the specialized services ecosystem supporting R&D. The quality of monitoring directly impacts the integrity of research findings, public trust in medical research, and ultimately, the pace at which safe and effective treatments become available to patients.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Other Professional, Scientific, and Technical Services › All Other Professional, Scientific, and Technical Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › ADMINISTRATIVE SUPPORT SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: N02CM7100175

Offers Received: 2

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Address: 4365 RT 1 S, PRINCETON, NJ, 08540

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

Financial Breakdown

Contract Ceiling: $36,506,288

Exercised Options: $33,408,569

Current Obligation: $32,481,380

Actual Outlays: $6,287,342

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline