Interior Department's $20.6M Clinical Trials Reporting contract awarded to Essex Management LLC

Contract Overview

Contract Amount: $20,648,468 ($20.6M)

Contractor: Essex Management LLC

Awarding Agency: Department of the Interior

Start Date: 2021-09-01

End Date: 2026-08-31

Contract Duration: 1,825 days

Daily Burn Rate: $11.3K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 7

Pricing Type: TIME AND MATERIALS

Sector: Other

Official Description: CLINICAL TRIALS REPORTING OFFICE (CTRO)

Place of Performance

Location: BETHESDA, MONTGOMERY County, MARYLAND, 20892

State: Maryland Government Spending

Plain-Language Summary

Department of the Interior obligated $20.6 million to ESSEX MANAGEMENT LLC for work described as: CLINICAL TRIALS REPORTING OFFICE (CTRO) Key points: 1. Value for money appears fair given the 5-year duration and Time and Materials pricing. 2. Competition dynamics indicate a full and open process, suggesting potential for competitive pricing. 3. Risk indicators include the Time and Materials contract type, which can lead to cost overruns if not managed closely. 4. Performance context is tied to the Clinical Trials Reporting Office (CTRO), a critical function for research oversight. 5. Sector positioning is within professional services, specifically scientific and technical consulting.

Value Assessment

Rating: fair

The contract's total value of $20.6 million over five years suggests a moderate annual spend. Benchmarking against similar contracts for scientific and technical consulting services is challenging without more specific service details. However, the Time and Materials (T&M) pricing structure, while flexible, carries inherent risks for cost control compared to fixed-price contracts. The value proposition hinges on the effective delivery of services by Essex Management LLC and the government's ability to manage the T&M aspects to prevent scope creep and ensure efficient resource utilization.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under full and open competition, indicating that all responsible sources were permitted to submit offers. The presence of 7 bidders suggests a reasonably competitive environment. A higher number of bidders generally correlates with better price discovery and potentially lower prices for the government. The specific details of the bidding process and the evaluation criteria would provide further insight into the effectiveness of the competition.

Taxpayer Impact: A full and open competition is beneficial for taxpayers as it maximizes the pool of potential offerors, fostering a competitive environment that can drive down costs and improve service quality.

Public Impact

The primary beneficiaries are the Department of the Interior's Clinical Trials Reporting Office (CTRO). Services delivered likely involve the management, oversight, and reporting of clinical trials data. The geographic impact is primarily national, supporting federal research initiatives. Workforce implications may include specialized roles in clinical research administration and data management.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Time and Materials contract type poses a risk of cost escalation if not closely monitored.
The duration of the contract (5 years) requires sustained oversight to ensure continued value.
Reliance on a single contractor for a critical function like clinical trial reporting necessitates robust performance management.

Positive Signals

Awarded through full and open competition, indicating a broad market search.
The contract has a defined period of performance, allowing for reassessment and potential re-competition.
The existence of a dedicated Clinical Trials Reporting Office suggests a structured approach to research oversight.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically focusing on consulting. This sector is characterized by a wide range of specialized expertise. The market size for such services is substantial, with numerous firms competing for government contracts. The Department of the Interior's need for clinical trials reporting aligns with broader federal efforts in research integrity and data management, making this a niche but important area within the consulting landscape.

Small Business Impact

The data indicates that this contract was not specifically set aside for small businesses (ss: false, sb: false). Therefore, small businesses would have had to compete directly with larger firms under the full and open competition. There is no explicit information on subcontracting plans for small businesses. The impact on the small business ecosystem is likely minimal unless specific subcontracting opportunities arise from the prime contractor, Essex Management LLC.

Oversight & Accountability

Oversight mechanisms would typically involve the Contracting Officer's Representative (COR) responsible for monitoring performance, ensuring compliance with contract terms, and managing the Time and Materials aspects. Accountability measures are embedded in the contract's performance standards and deliverables. Transparency is facilitated through contract databases like FPDS. Inspector General jurisdiction would apply if any allegations of fraud, waste, or abuse arise.

Related Government Programs

Clinical Research Services
Scientific and Technical Consulting
Federal Research Administration
Data Management Services
Department of Health and Human Services Contracts

Risk Flags

Time and Materials Contract Type
Long Contract Duration (5 Years)
Potential for Cost Overruns

Frequently Asked Questions

What is this federal contract paying for?

Department of the Interior awarded $20.6 million to ESSEX MANAGEMENT LLC. CLINICAL TRIALS REPORTING OFFICE (CTRO)

Who is the contractor on this award?

The obligated recipient is ESSEX MANAGEMENT LLC.

Which agency awarded this contract?

Awarding agency: Department of the Interior (Departmental Offices).

What is the total obligated amount?

The obligated amount is $20.6 million.

What is the period of performance?

Start: 2021-09-01. End: 2026-08-31.

What is the specific nature of the 'Clinical Trials Reporting Office (CTRO)' services provided under this contract?

The provided data indicates the contract is for 'CLINICAL TRIALS REPORTING OFFICE (CTRO)' services, falling under the NAICS code 541690 for 'Other Scientific and Technical Consulting Services'. While the exact scope is not detailed, it implies services related to the management, oversight, collection, analysis, and reporting of data from clinical trials. This could encompass regulatory compliance, data integrity checks, report generation for federal agencies or research bodies, and potentially the development or maintenance of systems used for tracking trial progress and outcomes. The 'Departmental Offices' as the specific sub-agency suggests these services support internal DOI functions or cross-agency initiatives related to research and development where clinical trials are involved.

How does the Time and Materials (T&M) pricing structure for this contract compare to industry standards for similar consulting services?

Time and Materials (T&M) contracts are common in government contracting, particularly for services where the scope of work is not clearly defined at the outset or is expected to evolve. For consulting services like those provided by Essex Management LLC, T&M offers flexibility. However, it is generally considered less cost-effective for the government compared to fixed-price contracts because the contractor is reimbursed for actual labor hours and material costs, plus a fixed fee or overhead. Industry standards suggest that T&M contracts require stringent government oversight to manage labor hours and prevent cost overruns. Benchmarking the specific rates for labor categories and material markups against market data would be necessary to assess if the pricing is competitive. Without that granular data, it's difficult to definitively state if it aligns with or deviates from typical market rates.

What are the potential risks associated with a 5-year Time and Materials contract for clinical trials reporting?

A significant risk with a 5-year Time and Materials (T&M) contract for clinical trials reporting is the potential for cost escalation. Since the contractor is paid based on actual hours worked and materials used, there's an incentive to extend tasks or bill for more hours than strictly necessary if oversight is lax. Scope creep is another major risk; as the project evolves, additional requirements might be added without a formal re-negotiation of the total contract value, leading to unforeseen expenses. Furthermore, the long duration means that the government is locked into this contractor for an extended period, potentially missing out on better pricing or innovative solutions that might emerge from future competitions. Effective contract management, including detailed monitoring of labor hours, material costs, and regular performance reviews, is crucial to mitigate these risks.

Given the full and open competition with 7 bidders, what does this imply about the contractor's track record and the overall market for these services?

The fact that this contract was awarded under full and open competition with 7 bidders suggests a healthy and accessible market for clinical trials reporting and related scientific/technical consulting services. It implies that Essex Management LLC was able to successfully compete against a diverse set of firms, indicating they likely possess the necessary qualifications, experience, and competitive pricing to win the award. A higher number of bidders generally points to a more robust market where multiple companies have the capability and interest to pursue such contracts. This competitive landscape can be advantageous for the government, as it increases the likelihood of receiving quality services at a reasonable price. It also suggests that Essex Management LLC's track record, proposals, and pricing were deemed superior among the seven contenders at the time of award.

How does the $20.6 million spending over 5 years compare to historical spending patterns for similar services within the Department of the Interior or other federal agencies?

The total contract value of $20.6 million spread over 5 years equates to an average annual spend of approximately $4.12 million. To assess this against historical patterns, one would need to analyze past contracts awarded by the Department of the Interior (DOI) or other agencies (like HHS, NIH, FDA) for clinical trial management, reporting, or related scientific consulting services. If similar contracts in the past were significantly smaller or larger, it would indicate a shift in spending. For instance, if historical spending was consistently lower, this contract might represent an expansion of services or an increase in the complexity of trials being managed. Conversely, if historical spending was higher, it could suggest a consolidation of services or a move towards more cost-effective solutions. Without access to historical spending data for comparable services, a precise comparison is not possible, but the annual average provides a baseline for future analysis.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Management, Scientific, and Technical Consulting Services › Other Scientific and Technical Consulting Services

Product/Service Code: IT AND TELECOM - INFORMATION TECHNOLOGY AND TELECOMMUNICATIONS › IT AND TELECOM - APLLICATIONS

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Solicitation ID: 140D0421R0007

Offers Received: 7

Pricing Type: TIME AND MATERIALS (Y)

Evaluated Preference: NONE

Contractor Details

Address: 12 PARTRIDGE DR, ESSEX JUNCTION, VT, 05452

Business Categories: Category Business, Limited Liability Corporation, Partnership or Limited Liability Partnership, Small Business, Special Designations, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $20,648,663

Exercised Options: $20,648,663

Current Obligation: $20,648,468

Actual Outlays: $18,139,594

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 140D0421D0007

IDV Type: IDC

Timeline