HHS awards $11M contract for clinical evidence reviews and safety studies to International Consulting Associates

Contract Overview

Contract Amount: $11,050,921 ($11.1M)

Contractor: International Consulting Associates, Inc.

Awarding Agency: Department of Health and Human Services

Start Date: 2025-06-04

End Date: 2026-06-03

Contract Duration: 364 days

Daily Burn Rate: $30.4K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: FIRM FIXED PRICE

Sector: Healthcare

Official Description: CLINICAL EVIDENCE SYSTEMATIC LITERATURE REVIEW TASK ORDER AND POSTMARKET SAFETY STUDY

Place of Performance

Location: ARLINGTON, ARLINGTON County, VIRGINIA, 22201

State: Virginia Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $11.1 million to INTERNATIONAL CONSULTING ASSOCIATES, INC. for work described as: CLINICAL EVIDENCE SYSTEMATIC LITERATURE REVIEW TASK ORDER AND POSTMARKET SAFETY STUDY Key points: 1. Contract focuses on critical public health functions: systematic literature reviews and postmarket safety studies. 2. The award was made under a broader Blanket Purchase Agreement (BPA) Call, suggesting a pre-vetted vendor pool. 3. Fixed-price contract type aims to control costs and provide predictable spending. 4. The duration of one year (364 days) is typical for task orders of this nature. 5. Contractor's performance and value will be assessed against the scope of work for systematic reviews and safety monitoring. 6. The specific IT service code (541519) indicates a focus on computer-related services beyond standard IT infrastructure.

Value Assessment

Rating: good

The contract value of $11.05 million for a one-year period appears reasonable for specialized services like systematic literature reviews and postmarket safety studies, which require significant expertise. Benchmarking against similar contracts for scientific literature analysis and regulatory support would provide a more precise value-for-money assessment. The firm fixed-price structure helps mitigate cost overrun risks for the government.

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 allows the government to select the best value offering. The specific number of bidders is not provided, but the competition type suggests a robust selection process.

Taxpayer Impact: Full and open competition is favorable for taxpayers as it typically drives down prices through market forces and ensures the government receives competitive bids for its requirements.

Public Impact

The Food and Drug Administration (FDA) benefits by obtaining essential services for evaluating clinical evidence and monitoring product safety. The public benefits from enhanced oversight of medical products, contributing to patient safety and informed regulatory decisions. Services delivered include systematic literature reviews and postmarket safety studies, crucial for understanding real-world product performance. The contract supports the FDA's mission to protect public health by ensuring the safety and effectiveness of medical products.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for scope creep if the definition of 'systematic literature review' or 'postmarket safety study' is not tightly defined.
Reliance on a single contractor for critical safety data analysis could pose a risk if performance falters.
Ensuring the contractor possesses and maintains the necessary subject matter expertise across diverse medical product areas.

Positive Signals

Awarded under full and open competition, suggesting a competitive process that likely yielded a fair price.
Firm fixed-price contract type provides cost certainty for the government.
The contract supports a critical public health function, aligning with the FDA's core mission.

Sector Analysis

This contract falls within the professional, scientific, and technical services sector, specifically focusing on health and regulatory consulting. The market for such services is driven by the need for specialized expertise in scientific literature analysis, data interpretation, and regulatory compliance. Comparable spending benchmarks would involve analyzing other FDA contracts for similar scientific review and safety monitoring tasks, as well as contracts awarded by other health agencies for evidence synthesis.

Small Business Impact

The contract was awarded under full and open competition and does not indicate a small business set-aside. There is no explicit information on subcontracting plans for small businesses. The impact on the small business ecosystem would depend on whether small businesses are part of the supply chain for International Consulting Associates, Inc. or if they participated in the bidding process.

Oversight & Accountability

Oversight will likely be managed by the Food and Drug Administration contracting officers and program managers responsible for the clinical evidence and postmarket safety functions. Accountability measures are inherent in the firm fixed-price contract, requiring deliverables to meet specified standards. Transparency is facilitated through contract award databases, though detailed performance metrics may not be publicly disclosed.

Related Government Programs

FDA Postmarket Surveillance
Clinical Trial Data Analysis
Medical Device Safety Monitoring
Pharmaceutical Risk Management
Systematic Review Services

Risk Flags

Potential for performance issues if contractor lacks specialized expertise.
Risk of inadequate scope definition leading to cost overruns or missed deliverables.
Reliance on contractor's data integrity for critical safety assessments.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $11.1 million to INTERNATIONAL CONSULTING ASSOCIATES, INC.. CLINICAL EVIDENCE SYSTEMATIC LITERATURE REVIEW TASK ORDER AND POSTMARKET SAFETY STUDY

Who is the contractor on this award?

The obligated recipient is INTERNATIONAL CONSULTING ASSOCIATES, INC..

Which agency awarded this contract?

Awarding agency: Department of Health and Human Services (Food and Drug Administration).

What is the total obligated amount?

The obligated amount is $11.1 million.

What is the period of performance?

Start: 2025-06-04. End: 2026-06-03.

What is the track record of International Consulting Associates, Inc. in performing similar systematic literature reviews and postmarket safety studies for federal agencies?

Assessing the track record of International Consulting Associates, Inc. (ICA) requires a review of their past performance on federal contracts, particularly those involving scientific literature synthesis and regulatory support. Information on their past performance ratings, any awards or commendations received, and any instances of contract disputes or terminations would be crucial. Specifically, examining their experience with the Food and Drug Administration (FDA) or other health-related agencies would provide direct insight into their capabilities. A detailed analysis would involve looking at the complexity and scale of previous projects, the types of medical products or therapeutic areas covered, and client feedback. Without specific past performance data readily available in the public domain for this particular contract, a thorough assessment would necessitate consulting government performance databases or requesting information from the awarding agency.

How does the $11.05 million contract value compare to similar systematic literature review and postmarket safety study contracts awarded by the FDA or other agencies?

To benchmark the $11.05 million contract value, a comparative analysis of similar contracts is necessary. This involves identifying contracts with comparable scopes of work, such as systematic literature reviews, meta-analyses, and postmarket surveillance studies, awarded by the FDA or other federal health agencies like the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC). Key comparison points include the contract duration, the specific services rendered, the complexity of the subject matter, and the number of bidders. For instance, if similar one-year contracts for specialized scientific reviews have ranged from $5 million to $15 million, then ICA's $11.05 million award would appear to be within a reasonable market range. Conversely, if comparable contracts were significantly lower or higher, it would warrant further investigation into the specific requirements and market conditions that influenced the pricing.

What are the primary risks associated with this contract, and what mitigation strategies are in place?

Primary risks associated with this contract include potential deficiencies in the quality or timeliness of the systematic literature reviews and safety studies, which could impact regulatory decision-making and public health. Another risk is the contractor's ability to maintain the necessary subject matter expertise across diverse medical fields. Furthermore, if the scope of work is not precisely defined, there's a risk of scope creep, leading to cost overruns or delays. Mitigation strategies likely include robust government oversight, clearly defined performance standards and deliverables, regular progress reviews, and potentially performance-based incentives or penalties. The firm fixed-price nature of the contract also incentivizes the contractor to manage their costs and resources effectively to meet the defined scope within the agreed-upon budget.

How effective is the FDA's use of Blanket Purchase Agreements (BPAs) and BPA Calls for procuring specialized scientific and technical services like these?

Blanket Purchase Agreements (BPAs) and their subsequent Calls are generally an effective mechanism for federal agencies to procure recurring services and supplies from pre-vetted vendors. For specialized services like systematic literature reviews and safety studies, a BPA can streamline the acquisition process by establishing pre-negotiated terms, conditions, and pricing. This allows the FDA to issue task orders (BPA Calls) rapidly when a need arises, reducing lead times and administrative burden. The effectiveness hinges on the initial vetting process for the BPA, ensuring that the selected vendors possess the requisite expertise and competitive pricing. When used appropriately, BPAs can lead to cost savings through volume purchasing and faster delivery of critical services, thereby enhancing the agency's ability to respond efficiently to evolving public health needs.

What is the historical spending pattern for clinical evidence review and postmarket safety studies by the FDA, and how does this contract fit within that pattern?

Analyzing the FDA's historical spending on clinical evidence review and postmarket safety studies provides context for this $11.05 million contract. This would involve examining aggregate spending data over several fiscal years for contracts related to systematic literature reviews, meta-analyses, safety surveillance, and risk assessment. Understanding the typical annual investment in these areas helps determine if this contract represents a significant increase, decrease, or continuation of established spending levels. Factors such as new regulatory mandates, emerging public health threats, or shifts in research priorities can influence historical spending. This specific contract, awarded under a BPA Call, suggests it aligns with ongoing or anticipated needs for these services, fitting within a pattern of continuous support for FDA's regulatory and safety functions.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Computer Systems Design and Related Services › Other Computer Related Services

Product/Service Code: SUPPORT SVCS (PROF, ADMIN, MGMT) › PROFESSIONAL SERVICES

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION

Solicitation Procedures: SUBJECT TO MULTIPLE AWARD FAIR OPPORTUNITY

Pricing Type: FIRM FIXED PRICE (J)

Evaluated Preference: NONE

Contractor Details

Address: 2000 14TH ST N STE 350, ARLINGTON, VA, 22201

Business Categories: 8(a) Program Participant, Category Business, Corporate Entity Not Tax Exempt, Minority Owned Business, Other Minority Owned Business, Self-Certified Small Disadvantaged Business, Small Business, Special Designations, Subchapter S Corporation, U.S.-Owned Business

Financial Breakdown

Contract Ceiling: $37,257,480

Exercised Options: $11,050,921

Current Obligation: $11,050,921

Actual Outlays: $345,250

Contract Characteristics

Commercial Item: COMMERCIAL PRODUCTS/SERVICES

Cost or Pricing Data: NO

Parent Contract

Parent Award PIID: 75F40124A00021

IDV Type: BPA

Timeline