NIH awards $18.5M for clinical research support, highlighting R&D in life sciences

Contract Overview

Contract Amount: $18,539,258 ($18.5M)

Contractor: RHO Federal Systems Division Inc

Awarding Agency: Department of Health and Human Services

Start Date: 2008-09-30

End Date: 2014-09-29

Contract Duration: 2,190 days

Daily Burn Rate: $8.5K/day

Competition Type: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Number of Offers Received: 3

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: NHLBI-DE-08-16CLINICAL RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS)

Place of Performance

Location: CHAPEL HILL, CHATHAM County, NORTH CAROLINA, 27517

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $18.5 million to RHO FEDERAL SYSTEMS DIVISION INC for work described as: NHLBI-DE-08-16CLINICAL RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS) Key points: 1. Contract provides essential operational and management support for clinical research initiatives. 2. Focus on life sciences R&D indicates strategic investment in health advancements. 3. Long-term contract duration suggests a sustained need for these services. 4. The award was made under full and open competition, promoting a competitive environment. 5. Contract type (Cost Plus Fixed Fee) allows for flexibility while managing costs. 6. Geographic focus on North Carolina points to regional research strengths.

Value Assessment

Rating: good

The contract value of $18.5 million over approximately six years for clinical research operations and management support appears reasonable given the scope. Benchmarking against similar large-scale research support contracts is challenging without more specific service details. However, the fixed fee component within the Cost Plus Fixed Fee structure suggests an effort to control overall project costs while accommodating research-related expenses. The contract's duration and the nature of the services indicate a significant investment in advancing medical research.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

This contract was awarded under 'Full and Open Competition After Exclusion of Sources,' indicating that multiple bidders were likely considered. The presence of three bidders suggests a moderate level of competition for this specialized research support service. While not a completely unrestricted competition, it allowed for a broad range of qualified contractors to participate, which generally aids in price discovery and ensures a selection based on merit and capability.

Taxpayer Impact: The competitive nature of this award is beneficial for taxpayers, as it likely drove down costs compared to a sole-source or limited competition scenario. Ensuring multiple bids helps secure a fair market price for essential research support services.

Public Impact

The primary beneficiaries are researchers and institutions conducting clinical trials, enabling them to focus on scientific discovery. Services delivered include crucial operational and management support, streamlining the research process. The contract's geographic impact is centered in North Carolina, leveraging regional expertise. Workforce implications include the potential for skilled jobs in research administration and operations within the supported region.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for cost overruns inherent in Cost Plus Fixed Fee contracts if not closely monitored.
Reliance on a single contractor for critical research operations could pose a risk if performance falters.
The specific details of 'management support' are broad and require ongoing scrutiny to ensure efficiency.

Positive Signals

Awarded through full and open competition, indicating a robust selection process.
Long contract duration suggests a stable and reliable partnership for critical research functions.
Focus on specialized R&D aligns with national health priorities.

Sector Analysis

This contract falls within the Research and Development sector, specifically focusing on life sciences. The market for clinical research operations and management support is substantial, driven by pharmaceutical companies, government agencies like NIH, and academic institutions. This contract represents a significant investment in the infrastructure necessary for conducting complex clinical trials, contributing to the broader ecosystem of biomedical innovation and potentially supporting regional economic development in research hubs.

Small Business Impact

The provided data indicates that small business participation (ss: false, sb: false) was not a primary set-aside criterion for this contract. Therefore, the direct impact on small businesses through set-asides is minimal. However, the prime contractor, RHO FEDERAL SYSTEMS DIVISION INC, may engage small businesses as subcontractors, contributing indirectly to the small business ecosystem. Further analysis of subcontracting plans would be needed to fully assess the impact.

Oversight & Accountability

Oversight for this contract would typically be managed by the National Institutes of Health (NIH), a division of HHS. Mechanisms likely include regular performance reviews, financial audits, and adherence to contract milestones. The Inspector General for HHS provides an additional layer of oversight for fraud, waste, and abuse. Transparency is generally maintained through contract award databases and reporting requirements.

Related Government Programs

Clinical Trial Management Systems
Biomedical Research Support Services
Health Research Operations
National Institutes of Health Research Grants
Life Sciences Research and Development

Risk Flags

Potential for cost overruns due to CPFF structure.
Performance degradation over long contract duration.
Risk of outdated methodologies if not actively managed.
Dependence on a single contractor for critical functions.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $18.5 million to RHO FEDERAL SYSTEMS DIVISION INC. NHLBI-DE-08-16CLINICAL RESEARCH OPERATIONS AND MANAGEMENT SUPPORT (CROMS)

Who is the contractor on this award?

The obligated recipient is RHO FEDERAL SYSTEMS DIVISION 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 $18.5 million.

What is the period of performance?

Start: 2008-09-30. End: 2014-09-29.

What is the track record of RHO FEDERAL SYSTEMS DIVISION INC in managing large-scale clinical research contracts?

Assessing the specific track record of RHO FEDERAL SYSTEMS DIVISION INC requires a deeper dive into their contract history beyond this single award. While this $18.5 million contract indicates capability in managing significant research operations, a comprehensive review would involve examining past performance on similar government contracts, including client satisfaction, adherence to timelines and budgets, and any documented performance issues or commendations. Information from sources like the Federal Procurement Data System (FPDS) or Contractor Performance Assessment Reporting System (CPARS) would be crucial for a thorough evaluation of their past performance in clinical research support.

How does the Cost Plus Fixed Fee (CPFF) structure compare to other contract types for similar R&D services?

The Cost Plus Fixed Fee (CPFF) contract type is common in research and development where the scope of work can be uncertain or evolve. It allows the government to reimburse the contractor for allowable costs plus a predetermined fixed fee representing profit. Compared to Firm-Fixed-Price (FFP) contracts, CPFF offers more flexibility for the contractor to adapt to unforeseen technical challenges, which is beneficial in R&D. However, it carries higher risk for the government regarding cost control, as costs can exceed initial estimates. Other types like Cost Plus Incentive Fee (CPIF) or Cost Plus Award Fee (CPAF) introduce performance incentives, potentially aligning contractor and government goals more closely than a simple fixed fee.

What are the key performance indicators (KPIs) used to measure the success of this clinical research support contract?

Key Performance Indicators (KPIs) for a contract like this would typically focus on the efficiency and effectiveness of research operations. Examples include the timely recruitment and enrollment of participants in clinical trials, adherence to study protocols and regulatory requirements (e.g., FDA, GCP), data accuracy and completeness, turnaround times for data analysis, and overall project milestone achievement. Budget adherence and effective resource management are also critical. The specific KPIs would be detailed in the contract's Performance Work Statement (PWS) and are essential for monitoring contractor performance and ensuring the value derived from the $18.5 million investment.

What is the historical spending trend for clinical research operations and management support by the NIH?

Analyzing historical spending trends for clinical research operations and management support by the NIH requires access to comprehensive federal procurement data over multiple fiscal years. While this specific contract award of $18.5 million provides a data point for 2008-2014, understanding the broader trend would involve aggregating spending on similar contract vehicles and categories across the NIH. Factors influencing these trends include shifts in research priorities, budget allocations, the increasing complexity of clinical trials, and the outsourcing of research support functions. A detailed analysis would reveal whether NIH's investment in such support services has been increasing, decreasing, or remaining relatively stable over time.

What are the potential risks associated with the long duration (6 years) of this contract?

The six-year duration of this contract presents several potential risks. Firstly, the longer timeframe increases the possibility of scope creep or the need for significant modifications if research objectives or methodologies change substantially over the years. Secondly, maintaining consistent performance quality from the contractor over an extended period can be challenging; performance may degrade without rigorous oversight. Thirdly, technological advancements or changes in best practices within clinical research could render the contracted services or methodologies outdated by the contract's end. Finally, a long-term commitment ties up significant funds, potentially limiting flexibility for the NIH to pivot to new research priorities or alternative support models if needed.

Industry Classification

NAICS: Professional, Scientific, and Technical Services › Scientific Research and Development Services › Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)

Product/Service Code: RESEARCH AND DEVELOPMENT › OTHER RESEARCH/DEVELOPMENT

Competition & Pricing

Extent Competed: FULL AND OPEN COMPETITION AFTER EXCLUSION OF SOURCES

Solicitation Procedures: NEGOTIATED PROPOSAL/QUOTE

Offers Received: 3

Pricing Type: COST PLUS FIXED FEE (U)

Evaluated Preference: NONE

Contractor Details

Parent Company: RHO Incorporated (UEI: 932325574)

Address: 6330 QUADRANGLE DR STE 500, CHAPEL HILL, NC, 27517

Business Categories: Category Business, Corporate Entity Not Tax Exempt, Small Business

Financial Breakdown

Contract Ceiling: $18,539,258

Exercised Options: $18,539,258

Current Obligation: $18,539,258

Contract Characteristics

Commercial Item: COMMERCIAL ITEM PROCEDURES NOT USED

Timeline