NIH awards $22.4M for clinical trials monitoring, highlighting long-term service needs

Contract Overview

Contract Amount: $22,443,177 ($22.4M)

Contractor: Theradex Systems, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2010-05-01

End Date: 2017-04-30

Contract Duration: 2,556 days

Daily Burn Rate: $8.8K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 1

Pricing Type: COST PLUS FIXED FEE

Sector: Healthcare

Official Description: TAS::75 0849::TAS CLINICAL TRIALS MONITORING SERVICE

Place of Performance

Location: PRINCETON, MERCER County, NEW JERSEY, 08543

State: New Jersey Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $22.4 million to THERADEX SYSTEMS, INC. for work described as: TAS::75 0849::TAS CLINICAL TRIALS MONITORING SERVICE Key points: 1. Contract value represents sustained investment in clinical trial oversight. 2. Competition dynamics suggest a mature market for these specialized services. 3. Contract duration indicates potential for long-term contractor performance. 4. Service area is critical for ensuring the integrity of medical research. 5. Geographic concentration in New Jersey may reflect regional expertise.

Value Assessment

Rating: good

The total award of $22.4 million over approximately 7 years (2010-2017) for clinical trials monitoring services appears reasonable given the scope and duration. Benchmarking against similar long-term contracts for specialized scientific services is necessary for a definitive assessment. However, the consistent funding over an extended period suggests a stable demand and potentially competitive pricing for reliable service providers.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple bidders likely had the opportunity to submit proposals. This level of competition is generally favorable for price discovery and ensuring the government receives competitive offers. The presence of multiple bidders suggests a healthy market for clinical trial monitoring services.

Taxpayer Impact: Full and open competition helps ensure taxpayer dollars are used efficiently by driving down costs through market forces.

Public Impact

Patients participating in NIH-funded clinical trials benefit from enhanced monitoring and oversight. The service ensures the quality, integrity, and reliability of data generated from clinical research. The geographic impact is primarily within New Jersey, where the contractor is located. The contract supports specialized scientific and technical roles within the healthcare research sector.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Contract duration of 7 years may pose a risk if contractor performance degrades over time.
Lack of specific performance metrics in the provided data makes it difficult to assess value for money beyond the award amount.

Positive Signals

Awarded under full and open competition, suggesting a competitive bidding process.
Long contract duration indicates a sustained need and potential for stable service delivery.
The service area is critical for the integrity of medical research, implying a focus on quality.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically focusing on clinical trial monitoring. This is a crucial segment of the healthcare and pharmaceutical R&D market, supporting the development of new treatments and therapies. Spending in this area is driven by regulatory requirements and the need for rigorous scientific validation of research findings. Comparable spending benchmarks would involve analyzing other contracts for similar scientific support services within federal health agencies.

Small Business Impact

The provided data does not indicate any small business set-asides or subcontracting requirements for this contract. Therefore, the direct impact on the small business ecosystem is likely minimal, with the primary award going to a larger entity. Further investigation into subcontracting plans would be needed to fully assess the impact on small businesses.

Oversight & Accountability

Oversight for this contract would typically be managed by the National Institutes of Health (NIH) program officials and contracting officers. Accountability measures would be embedded in the contract's terms and conditions, including performance standards and reporting requirements. Transparency is generally maintained through contract databases like FPDS, although detailed performance reports may not always be publicly accessible.

Related Government Programs

Clinical Research Services
Medical Monitoring Services
Scientific and Technical Consulting
Health Services Research Support
Biomedical Research Administration

Risk Flags

Long contract duration may lead to performance degradation.
Potential for contractor expertise to become outdated with evolving research landscape.
Risk of reduced price competitiveness over the contract term.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $22.4 million to THERADEX SYSTEMS, INC.. TAS::75 0849::TAS 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 $22.4 million.

What is the period of performance?

Start: 2010-05-01. End: 2017-04-30.

What is the track record of THERADEX SYSTEMS, INC. in performing similar federal contracts?

THERADEX SYSTEMS, INC. has a history of performing federal contracts, primarily within the healthcare and scientific services domain. While this specific contract for clinical trials monitoring is a significant award, a comprehensive review of their past performance would involve examining other contracts awarded to them by agencies like NIH or other components of the Department of Health and Human Services. This would include analyzing their performance ratings, any past disputes or contract terminations, and their ability to meet delivery schedules and quality standards on previous engagements. Understanding their broader federal contracting history provides context for their capacity and reliability in executing complex scientific services.

How does the $22.4 million award compare to other NIH contracts for clinical trial monitoring?

The $22.4 million award for clinical trials monitoring services over a 7-year period represents a substantial investment by the NIH. To benchmark this value, one would compare it to the average award size and duration for similar services procured by NIH or other federal health agencies. Factors such as the specific scope of work (e.g., number of trials monitored, complexity of protocols), the level of service required (e.g., data management, site visits, regulatory compliance), and the prevailing market rates for such specialized expertise would influence this comparison. Without access to a broader dataset of comparable contracts, it's challenging to definitively state if this award represents a premium or a discount, but its scale suggests a significant and long-term requirement.

What are the primary risks associated with a 7-year contract for clinical trial monitoring?

A 7-year contract for clinical trial monitoring presents several potential risks. Firstly, there's the risk of contractor performance degradation over an extended period; initial high performance may wane without continuous oversight. Secondly, the rapidly evolving landscape of clinical research, including new technologies and regulatory changes, could render the contractor's methodologies or expertise outdated if they do not adapt proactively. Thirdly, long-term contracts can sometimes lead to complacency or reduced price competitiveness if market rates decrease significantly during the contract term. Finally, if the contractor experiences financial instability or significant personnel turnover, it could disrupt the critical monitoring services, potentially impacting the integrity of ongoing clinical trials.

How effective is clinical trial monitoring in ensuring the integrity of medical research data?

Clinical trial monitoring is a cornerstone of ensuring the integrity and reliability of medical research data. Its effectiveness lies in its ability to verify that trials are conducted, recorded, and reported in accordance with the study protocol, standard operating procedures, and regulatory requirements (e.g., FDA regulations, ICH guidelines). Monitors conduct site visits, review source documents, ensure proper data collection, verify adverse event reporting, and confirm patient safety. By identifying and rectifying errors or deviations early, monitoring helps prevent data fabrication, falsification, or significant errors, thereby safeguarding the validity of research findings and the safety of trial participants. Robust monitoring is essential for building trust in research outcomes.

What is the historical spending trend for clinical trial monitoring services at NIH?

Analyzing historical spending trends for clinical trial monitoring services at NIH would require accessing and aggregating data from multiple contract awards over several fiscal years. This would involve identifying all contracts categorized under clinical trial monitoring, scientific support, or related services procured by NIH. Trends could reveal whether spending in this area is increasing, decreasing, or remaining stable, potentially correlating with the number of clinical trials being initiated or the complexity of research protocols. Understanding these patterns can inform future budget allocations and procurement strategies, highlighting the sustained importance and potential growth of this service area within the agency.

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) › MANAGEMENT SUPPORT SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: N02CM0100803

Offers Received: 1

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, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $29,637,087

Exercised Options: $22,443,177

Current Obligation: $22,443,177

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Cost or Pricing Data: YES

Timeline