HHS Awards $255M Contract to Care Access for Decentralized Clinical Research

Contract Overview

Contract Amount: $2,551,923 ($2.6M)

Contractor: Care Access Research LLC

Awarding Agency: Department of Health and Human Services

Start Date: 2024-08-23

End Date: 2029-08-30

Contract Duration: 1,833 days

Daily Burn Rate: $1.4K/day

Competition Type: FULL AND OPEN COMPETITION

Number of Offers Received: 16

Pricing Type: FIRM FIXED PRICE

Sector: R&D

Official Description: A PARTNERSHIP BETWEEN THE AGREEMENT RECIPIENT, CARE ACCESS, AND BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) TO ENHANCE INNOVATION WITH DECENTRALIZED CARE CAPABILITIES AND TO EXECUTE MORE EFFICIENT AND RELEVANT CLINICAL RESEARCH IN

Place of Performance

Location: BOSTON, SUFFOLK County, MASSACHUSETTS, 02110

State: Massachusetts Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $2.6 million to CARE ACCESS RESEARCH LLC for work described as: A PARTNERSHIP BETWEEN THE AGREEMENT RECIPIENT, CARE ACCESS, AND BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) TO ENHANCE INNOVATION WITH DECENTRALIZED CARE CAPABILITIES AND TO EXECUTE MORE EFFICIENT AND RELEVANT CLINICAL RESEARCH IN Key points: 1. Focuses on enhancing innovation in decentralized care and clinical research efficiency. 2. Contract awarded via full and open competition, suggesting a competitive bidding process. 3. Potential for improved patient access and reduced research costs through decentralized models. 4. Biotechnology R&D sector, with a significant award amount indicating substantial project scope.

Value Assessment

Rating: good

The contract is a definitive contract with a firm fixed price, which is standard for R&D projects. The award amount of $255M over approximately 5 years suggests a significant investment, but without specific deliverables or benchmarks, a precise value assessment is difficult.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating that multiple vendors had the opportunity to bid. This method generally promotes competitive pricing and ensures the government receives the best value.

Taxpayer Impact: The use of full and open competition aims to ensure taxpayer funds are used efficiently by fostering a competitive environment for research and development services.

Public Impact

Enhances access to clinical research for a wider patient population through decentralized capabilities. Aims to make clinical research more efficient and relevant, potentially speeding up medical advancements. Supports innovation in healthcare delivery models, moving towards more patient-centric approaches. Significant federal investment in biotechnology R&D, signaling a commitment to future health solutions.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Scope of work for decentralized research needs clear definition and oversight.
Ensuring data integrity and patient privacy in decentralized research settings.
Measuring the true efficiency gains and cost-effectiveness of decentralized models.

Positive Signals

Promotes innovation in healthcare research and delivery.
Leverages competition to potentially achieve better value.
Addresses a critical need for more efficient and accessible clinical trials.

Sector Analysis

This contract falls within the Research and Development in Biotechnology sector, specifically focusing on enhancing decentralized care capabilities for clinical research. Benchmarks for this specific niche are hard to define, but the award size is substantial for R&D.

Small Business Impact

The data indicates this contract was awarded under full and open competition and does not specify any small business set-asides or participation. Therefore, the direct impact or involvement of small businesses is not evident from this information.

Oversight & Accountability

Oversight will be crucial to ensure the effective implementation of decentralized research capabilities and to track the achievement of stated goals for efficiency and relevance. BARDA's involvement suggests a strategic focus on preparedness and innovation.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
Office of Assistant Secretary for Preparedness and Response Programs

Risk Flags

Potential for scope creep in defining 'decentralized care capabilities'.
Ensuring robust cybersecurity and data privacy for decentralized research.
Measuring the actual cost savings and efficiency gains compared to traditional methods.
Dependence on technology infrastructure and user adoption for decentralized models.
Long-term sustainability of decentralized research models beyond the contract period.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $2.6 million to CARE ACCESS RESEARCH LLC. A PARTNERSHIP BETWEEN THE AGREEMENT RECIPIENT, CARE ACCESS, AND BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY (BARDA) TO ENHANCE INNOVATION WITH DECENTRALIZED CARE CAPABILITIES AND TO EXECUTE MORE EFFICIENT AND RELEVANT CLINICAL RESEARCH IN

Who is the contractor on this award?

The obligated recipient is CARE ACCESS RESEARCH LLC.

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Office of Assistant Secretary for Preparedness and Response).

What is the total obligated amount?

The obligated amount is $2.6 million.

What is the period of performance?

Start: 2024-08-23. End: 2029-08-30.

What specific metrics will be used to measure the 'efficiency' and 'relevance' of the clinical research conducted under this contract?

The contract should clearly define Key Performance Indicators (KPIs) related to research timelines, participant recruitment rates, data quality, and the successful translation of research findings into actionable health solutions. Regular progress reports and independent evaluations will be necessary to validate these metrics and ensure the partnership meets its objectives.

What are the primary risks associated with implementing decentralized clinical research capabilities, and how will they be mitigated?

Key risks include data security and patient privacy breaches, ensuring the integrity and reliability of data collected remotely, and managing logistical challenges across diverse locations. Mitigation strategies should involve robust cybersecurity protocols, standardized data collection tools and training, clear communication channels, and contingency plans for technical failures or unforeseen issues.

How will the success of this partnership be evaluated in terms of its long-term impact on public health preparedness and innovation?

Success will be evaluated by the successful development and deployment of decentralized research infrastructure, the acceleration of critical medical product development, and the demonstrated ability to respond rapidly to public health emergencies. Quantifiable outcomes such as reduced time-to-market for new therapies and improved patient outcomes in trial settings will be key indicators.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in Biotechnology (except Nanobiotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › N – Health R&D Services

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Solicitation ID: 2023-BARDA-DCOHRE

Offers Received: 16

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 33 ARCH ST FL 17, BOSTON, MA, 02110

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

Financial Breakdown

Contract Ceiling: $2,551,923

Exercised Options: $2,551,923

Current Obligation: $2,551,923

Actual Outlays: $1,656,679

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED

Cost or Pricing Data: NO

Timeline