HHS awards $8.2M sole-source bridge contract for clinical studies management to Navitas Clinical Research Inc

Contract Overview

Contract Amount: $8,238,413 ($8.2M)

Contractor: Navitas Clinical Research Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2021-09-30

End Date: 2025-01-24

Contract Duration: 1,212 days

Daily Burn Rate: $6.8K/day

Competition Type: NOT COMPETED

Number of Offers Received: 1

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: CLINICAL STUDIES MANAGEMENT AND SUPPORT (CSMS) - SOLE SOURCE BRIDGE CONTRACT

Place of Performance

Location: ROCKVILLE, MONTGOMERY County, MARYLAND, 20852

State: Maryland Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $8.2 million to NAVITAS CLINICAL RESEARCH INC for work described as: CLINICAL STUDIES MANAGEMENT AND SUPPORT (CSMS) - SOLE SOURCE BRIDGE CONTRACT Key points: 1. The contract is a sole-source bridge, indicating a lack of competition and potential for higher costs. 2. The award value of $8.2M over approximately 4 years requires scrutiny for value for money. 3. The Research and Development sector often involves complex, specialized services where competition can be challenging. 4. The lack of small business participation is noted, which could be an area for future consideration.

Value Assessment

Rating: questionable

The $8.2M award for clinical studies management over 4 years, awarded sole-source, raises questions about pricing efficiency. Benchmarking against similar sole-source contracts for comparable services is recommended to assess if the price is reasonable.

Cost Per Unit: N/A

Competition Analysis

Competition Level: sole-source

This contract was awarded sole-source, meaning it was not competed. This limits price discovery and potentially leads to higher costs for taxpayers. The bridge nature suggests an urgent need, but a competitive process should be pursued for future requirements.

Taxpayer Impact: The sole-source nature of this award limits competitive pressure, potentially resulting in a higher cost to taxpayers than if the contract had been competed.

Public Impact

Taxpayers may be paying a premium due to the lack of competition. The NIH's reliance on a single vendor for critical clinical study support warrants oversight. Future procurement strategies should aim to foster competition to ensure best value.

Waste & Efficiency Indicators

Waste Risk Score: 67 / 10

Warning Flags

Sole-source award
Lack of competition
No small business participation

Positive Signals

Definitive contract award
Firm fixed price contract

Sector Analysis

This contract falls within the Research and Development sector, specifically for clinical studies management. Spending in this area can be substantial, and ensuring competitive pricing is crucial for efficient use of federal funds.

Small Business Impact

The data indicates no small business participation in this contract. Agencies should explore opportunities to engage small businesses in future procurements within this service area to promote economic growth and innovation.

Oversight & Accountability

The sole-source nature of this award necessitates robust oversight from the Department of Health and Human Services to ensure the contractor is meeting all performance requirements and that the pricing remains fair and reasonable throughout the contract period.

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

Sole-source award limits competition and price discovery.
Bridge contract may indicate planning or transition issues.
No small business participation noted.
High contract value requires diligent oversight for value.
Potential for vendor lock-in and reduced innovation.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $8.2 million to NAVITAS CLINICAL RESEARCH INC. CLINICAL STUDIES MANAGEMENT AND SUPPORT (CSMS) - SOLE SOURCE BRIDGE CONTRACT

Who is the contractor on this award?

The obligated recipient is NAVITAS CLINICAL RESEARCH 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 $8.2 million.

What is the period of performance?

Start: 2021-09-30. End: 2025-01-24.

What is the justification for the sole-source award, and what steps are being taken to ensure fair pricing?

The justification for a sole-source award typically involves specific circumstances, such as the urgency of the need or the unique capabilities of the vendor. Agencies must document these justifications thoroughly. To ensure fair pricing, agencies often rely on historical pricing data, market research, or independent government cost estimates. Regular contract performance reviews and audits are also critical to monitor costs and ensure value.

What is the risk associated with relying on a single vendor for clinical studies management, especially in a bridge contract scenario?

The primary risk of relying on a single vendor is the potential for vendor lock-in, reduced innovation, and inflated prices due to a lack of competitive pressure. In a bridge contract scenario, there's also a risk that the vendor may not be incentivized to perform at their best if they anticipate a future competitive award. This can impact the quality and timeliness of critical research activities.

How effective is this contract in supporting the National Institutes of Health's research objectives, and what are the long-term implications?

The effectiveness of this contract hinges on Navitas Clinical Research Inc.'s ability to deliver high-quality management and support for clinical studies, directly impacting the NIH's research progress. The long-term implications of a sole-source bridge contract include potential missed opportunities for cost savings through competition and the need for strategic planning to ensure future procurements are competitive and foster a robust vendor ecosystem.

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: SPECIAL STUDIES/ANALYSIS, NOT R&D › SPECIAL STUDIES - NOT R and D

Competition & Pricing

Extent Competed: NOT COMPETED

Solicitation Procedures: ONLY ONE SOURCE

Solicitation ID: 75N92021R0034

Offers Received: 1

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 11300 ROCKVILLE PIKE STE 500, ROCKVILLE, MD, 20852

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

Financial Breakdown

Contract Ceiling: $8,254,903

Exercised Options: $8,238,413

Current Obligation: $8,238,413

Actual Outlays: $8,219,359

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Timeline