NIH Awards $34.6M for COVID-19 Clinical Trial Management to PPD Development LP
Contract Overview
Contract Amount: $34,618,532 ($34.6M)
Contractor: PPD Development LP
Awarding Agency: Department of Health and Human Services
Start Date: 2022-05-06
End Date: 2022-11-05
Contract Duration: 183 days
Daily Burn Rate: $189.2K/day
Competition Type: FULL AND OPEN COMPETITION
Pricing Type: COST PLUS FIXED FEE
Sector: R&D
Official Description: COVID 19. THIS TASK ORDER IS TO PROVIDE COMPREHENSIVE/FULL CLINICAL TRIAL MANAGEMENT SUPPORT SERVICES TO THE ONGOING ACTIV-2 CLINICAL TRIAL. THE CONTRACTOR SHALL COMPLY WITH REGULATORY GUIDANCE, MAINTAIN DATA INTEGRITY, PROVIDE CRITICAL DATA RELATED
Place of Performance
Location: WILMINGTON, NEW HANOVER County, NORTH CAROLINA, 28401
Plain-Language Summary
Department of Health and Human Services obligated $34.6 million to PPD DEVELOPMENT LP for work described as: COVID 19. THIS TASK ORDER IS TO PROVIDE COMPREHENSIVE/FULL CLINICAL TRIAL MANAGEMENT SUPPORT SERVICES TO THE ONGOING ACTIV-2 CLINICAL TRIAL. THE CONTRACTOR SHALL COMPLY WITH REGULATORY GUIDANCE, MAINTAIN DATA INTEGRITY, PROVIDE CRITICAL DATA RELATED Key points: 1. Contract awarded for comprehensive clinical trial management for the ACTIV-2 trial. 2. Focus on regulatory compliance and data integrity for critical COVID-19 research. 3. PPD Development LP, a known entity in clinical research, is the contractor. 4. Spending falls within the Research and Development in Biotechnology sector.
Value Assessment
Rating: good
The $34.6 million award for 183 days of service appears reasonable for comprehensive clinical trial management. Benchmarking against similar large-scale clinical trial support contracts would provide further validation.
Cost Per Unit: N/A
Competition Analysis
Competition Level: full-and-open
The contract was awarded under full and open competition, suggesting a competitive bidding process. This method generally leads to better price discovery and value for the government.
Taxpayer Impact: Taxpayer funds are being used to support critical research into COVID-19 treatments, aiming for effective and safe therapies.
Public Impact
Supports ongoing research for COVID-19 treatments. Ensures data integrity and regulatory compliance in a critical public health study. Contractor has experience in clinical trial management. Funding allocated for a defined period of service delivery.
Waste & Efficiency Indicators
Waste Risk Score: 50 / 10
Warning Flags
- Short contract duration may limit long-term strategic planning.
- Fixed fee structure could incentivize cost overruns if not managed tightly.
Positive Signals
- Supports a high-priority public health initiative.
- Awarded through full and open competition.
- Contractor has relevant expertise.
Sector Analysis
This contract falls under Research and Development in Biotechnology, a sector crucial for advancing medical science and public health. Spending benchmarks for similar clinical trial management services would be relevant for comparison.
Small Business Impact
The data does not indicate any specific set-asides or participation goals for small businesses in this contract. Further analysis would be needed to determine if small businesses were involved as subcontractors.
Oversight & Accountability
The contract specifies compliance with regulatory guidance and data integrity, implying oversight mechanisms are in place. The National Institutes of Health (NIH) is responsible for overseeing this research funding.
Related Government Programs
- Research and Development in Biotechnology (except Nanobiotechnology)
- Department of Health and Human Services Contracting
- National Institutes of Health Programs
Risk Flags
- Short contract duration may require follow-on funding.
- Potential for cost creep in fixed-fee contracts if not managed diligently.
- Reliance on a single contractor for critical trial management.
- Lack of small business participation noted.
Tags
research-and-development-in-biotechnolog, department-of-health-and-human-services, nc, delivery-order, 10m-plus
Frequently Asked Questions
What is this federal contract paying for?
Department of Health and Human Services awarded $34.6 million to PPD DEVELOPMENT LP. COVID 19. THIS TASK ORDER IS TO PROVIDE COMPREHENSIVE/FULL CLINICAL TRIAL MANAGEMENT SUPPORT SERVICES TO THE ONGOING ACTIV-2 CLINICAL TRIAL. THE CONTRACTOR SHALL COMPLY WITH REGULATORY GUIDANCE, MAINTAIN DATA INTEGRITY, PROVIDE CRITICAL DATA RELATED
Who is the contractor on this award?
The obligated recipient is PPD DEVELOPMENT LP.
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 $34.6 million.
What is the period of performance?
Start: 2022-05-06. End: 2022-11-05.
What is the specific breakdown of costs within the $34.6 million, and how does it compare to industry standards for similar trial phases?
The provided data does not detail the cost breakdown. A thorough analysis would require access to the contract's financial statements, including direct labor, indirect costs, and fee allocation. Comparing these to industry benchmarks for Phase 3 or large-scale clinical trial management would reveal potential cost efficiencies or areas of concern.
What are the key performance indicators (KPIs) for PPD Development LP, and how will their performance be measured against these metrics?
The contract emphasizes regulatory compliance and data integrity, suggesting these are primary performance areas. Specific KPIs likely include adherence to Good Clinical Practice (GCP) guidelines, timely data submission, and successful protocol deviations management. Performance will be measured through regular reporting, audits, and potentially milestone achievement reviews by the NIH.
What is the potential impact of the short contract duration (183 days) on the overall success and long-term implications of the ACTIV-2 clinical trial?
The 183-day duration suggests this task order covers a specific phase or critical period of the ACTIV-2 trial. While it ensures focused support for that timeframe, it may necessitate follow-on contracts for continued management. This could lead to potential transition challenges and requires careful planning to ensure seamless continuity of trial operations and data integrity.
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
Pricing Type: COST PLUS FIXED FEE (U)
Evaluated Preference: NONE
Contractor Details
Address: 929 N FRONT ST, WILMINGTON, NC, 28401
Business Categories: Category Business, Corporate Entity Not Tax Exempt, Not Designated a Small Business, Special Designations, U.S.-Owned Business
Financial Breakdown
Contract Ceiling: $34,618,532
Exercised Options: $34,618,532
Current Obligation: $34,618,532
Actual Outlays: $37,714,831
Contract Characteristics
Commercial Item: COMMERCIAL PRODUCTS/SERVICES PROCEDURES NOT USED
Cost or Pricing Data: YES
Parent Contract
Parent Award PIID: 75N93021D00035
IDV Type: IDC
Timeline
Start Date: 2022-05-06
Current End Date: 2022-11-05
Potential End Date: 2022-11-05 00:00:00
Last Modified: 2025-07-09
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