HHS awards $3.96M for clinical research monitoring, with 6 bidders indicating competitive pricing

Contract Overview

Contract Amount: $3,960,433 ($4.0M)

Contractor: Comprehensive Research Solutions LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2022-06-01

End Date: 2027-02-28

Contract Duration: 1,733 days

Daily Burn Rate: $2.3K/day

Competition Type: COMPETED UNDER SAP

Number of Offers Received: 6

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: NHLBI CLINICAL RESEARCH MONITORING SERVICES

Place of Performance

Location: GAITHERSBURG, MONTGOMERY County, MARYLAND, 20878

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $4.0 million to COMPREHENSIVE RESEARCH SOLUTIONS LLC for work described as: NHLBI CLINICAL RESEARCH MONITORING SERVICES Key points: 1. The contract value of $3.96 million over 1733 days suggests a moderate annual spend. 2. With 6 bidders, the competition level appears healthy, likely driving favorable pricing. 3. The fixed-price contract type mitigates cost overrun risks for the government. 4. This award falls within the 'All Other Professional, Scientific, and Technical Services' NAICS code. 5. The contract is managed by the National Institutes of Health (NIH), a major research funding agency. 6. The contractor, Comprehensive Research Solutions LLC, is a new awardee for these services.

Value Assessment

Rating: good

The contract's total value of $3.96 million over nearly five years suggests a reasonable annual expenditure for clinical research monitoring. Benchmarking against similar contracts is challenging without more specific service details, but the presence of multiple bidders (6) implies that the pricing was likely competitive. The firm fixed-price nature of the award also suggests that the government secured a defined cost for the services, which is generally a positive indicator of value.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was competed under the Simplified Acquisition Procedures (SAP), which allows for full and open competition for awards below certain thresholds. The fact that six bidders participated indicates a robust level of interest and competition for these services. This level of competition is generally beneficial for price discovery and ensures that the government receives competitive offers.

Taxpayer Impact: A competitive bidding process with six offers helps ensure that taxpayer dollars are used efficiently by driving down costs through market forces.

Public Impact

Patients participating in NHLBI-funded clinical trials will benefit from rigorous monitoring, ensuring data integrity and participant safety. The services delivered will support the National Heart, Lung, and Blood Institute's mission to advance research. The contract's geographic impact is primarily focused on the Maryland area where the contractor is located, but research sites may be national. The contract supports specialized scientific and technical roles within the research monitoring field.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Limited public information on the contractor's specific track record for this type of complex monitoring.
The duration of the contract (over 4.5 years) requires ongoing performance monitoring to ensure continued value.

Positive Signals

The contract was competed, indicating a fair opportunity for multiple vendors to propose.
The firm fixed-price structure provides cost certainty for the government.
The award to a single entity suggests a focused approach to service delivery.

Sector Analysis

This contract falls under the Professional, Scientific, and Technical Services sector, specifically NAICS code 541990. This broad category includes a wide range of specialized services. The market for clinical research monitoring is significant, driven by the substantial investment in biomedical research by government agencies like NIH and private pharmaceutical companies. Comparable spending benchmarks would depend on the specific scope and scale of monitoring required, but NIH alone awards billions annually for research support services.

Small Business Impact

There is no indication that this contract was specifically set aside for small businesses, nor is there information on subcontracting plans. The award to Comprehensive Research Solutions LLC, without further details on its size, makes it difficult to assess the direct impact on the small business ecosystem. Future analysis could explore if this prime contractor has a history of engaging small businesses for subcontracting.

Oversight & Accountability

Oversight for this contract will be provided by the National Institutes of Health (NIH), likely through designated contracting officers and program managers. The firm fixed-price nature of the award provides a degree of accountability by defining the scope of work and associated costs. Transparency is generally maintained through contract award databases, but detailed performance metrics are typically internal.

Related Government Programs

NHLBI Clinical Research Support
NIH Research Grants Management
Biomedical Research Monitoring Services
Clinical Trial Oversight Contracts

Risk Flags

Contract duration exceeds 4 years, requiring sustained oversight.
Limited public information on contractor's specific experience in this niche.
Performance metrics not detailed in summary data.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $4.0 million to COMPREHENSIVE RESEARCH SOLUTIONS LLC. NHLBI CLINICAL RESEARCH MONITORING SERVICES

Who is the contractor on this award?

The obligated recipient is COMPREHENSIVE RESEARCH SOLUTIONS LLC.

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 $4.0 million.

What is the period of performance?

Start: 2022-06-01. End: 2027-02-28.

What is the specific scope of 'Clinical Research Monitoring Services' being provided under this contract?

The provided data indicates the contract is for 'NHLBI CLINICAL RESEARCH MONITORING SERVICES' awarded to COMPREHENSIVE RESEARCH SOLUTIONS LLC. While the specific details of the monitoring services are not fully elaborated in the summary data, such services typically involve ensuring that clinical trials are conducted, recorded, and reported in accordance with the study protocol, standard operating procedures, and regulatory requirements. This can include site visits, data verification, regulatory compliance checks, and safety monitoring to ensure the integrity of research data and the safety of trial participants. The National Heart, Lung, and Blood Institute (NHLBI) funds a wide range of research, so the scope could vary from early-phase studies to large-scale, multi-site clinical trials.

How does the awarded price of $3.96 million compare to similar clinical research monitoring contracts?

Directly comparing the $3.96 million award to similar contracts is challenging without knowing the precise scope, duration, and complexity of the services. However, the contract duration is 1733 days (approximately 4.7 years), making the average annual value around $842,600. This falls within a moderate range for specialized research support services. The fact that it was competed under SAP with 6 bidders suggests the pricing was considered competitive by the agency. To provide a more precise benchmark, one would need to analyze contracts with similar patient populations, number of sites monitored, and specific regulatory requirements.

What are the key performance indicators (KPIs) used to assess the contractor's performance?

The provided data does not specify the Key Performance Indicators (KPIs) for this contract. However, typical KPIs for clinical research monitoring services often include metrics related to data accuracy and completeness, timeliness of monitoring visits and reports, adherence to protocols and regulatory guidelines, participant safety issue identification and resolution, and overall compliance. The government, through the NIH, would likely establish specific performance standards and conduct regular reviews to ensure the contractor meets the required quality and timeliness of services throughout the contract period.

What is the track record of Comprehensive Research Solutions LLC in providing clinical research monitoring services?

The provided data indicates that Comprehensive Research Solutions LLC is the awardee for this contract. However, it does not offer details on their specific track record or past performance in providing clinical research monitoring services. As this is a new award, further investigation into the company's history, previous contracts (especially with government agencies), client references, and any reported performance issues would be necessary to fully assess their capabilities and reliability for this specific service.

What is the potential impact of this contract on the broader biomedical research ecosystem?

This contract plays a crucial role in supporting the NHLBI's research mission by ensuring the integrity and reliability of clinical trials. High-quality monitoring is essential for generating credible scientific evidence that can lead to advancements in understanding, preventing, and treating heart, lung, and blood diseases. By ensuring compliance and safety, the contract contributes to public trust in research findings and facilitates the translation of research into clinical practice, ultimately benefiting patient care and public health.

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) › PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: COMPETED UNDER SAP

Solicitation Procedures: SIMPLIFIED ACQUISITION

Solicitation ID: 75N92022Q0338

Offers Received: 6

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 708 BEACON HILL TER, GAITHERSBURG, MD, 20878

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

Financial Breakdown

Contract Ceiling: $3,960,433

Exercised Options: $3,960,433

Current Obligation: $3,960,433

Actual Outlays: $2,902,551

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Timeline