HHS awards $73M contract to PPD Development LP for clinical site monitoring

Contract Overview

Contract Amount: $73,196,564 ($73.2M)

Contractor: PPD Development LP

Awarding Agency: Department of Health and Human Services

Start Date: 2024-02-01

End Date: 2027-01-31

Contract Duration: 1,095 days

Daily Burn Rate: $66.8K/day

Competition Type: FULL AND OPEN COMPETITION

Pricing Type: COST PLUS FIXED FEE

Sector: R&D

Official Description: NIAID CLINICAL SITE MONITORING (NCSM)

Place of Performance

Location: WILMINGTON, NEW HANOVER County, NORTH CAROLINA, 28401

State: North Carolina Government Spending

Plain-Language Summary

Department of Health and Human Services obligated $73.2 million to PPD DEVELOPMENT LP for work described as: NIAID CLINICAL SITE MONITORING (NCSM) Key points: 1. The contract is for clinical site monitoring services, a critical component of research and development. 2. PPD Development LP is a significant player in the clinical research organization (CRO) space. 3. The award is a delivery order under a larger contract, suggesting potential for future task orders. 4. The sector is Research and Development in Biotechnology, a high-growth area.

Value Assessment

Rating: good

The contract value of $73.2M over three years appears reasonable for comprehensive clinical site monitoring services. Benchmarking against similar contracts for CRO services would provide a more precise assessment.

Cost Per Unit: N/A

Competition Analysis

Competition Level: full-and-open

The contract was awarded under full and open competition, indicating a robust price discovery process. This method generally leads to more competitive pricing.

Taxpayer Impact: The competitive award process is expected to yield fair pricing, ensuring taxpayer funds are used efficiently for critical research support.

Public Impact

Supports critical clinical trials for NIH research initiatives. Ensures data integrity and regulatory compliance in biotechnology research. Facilitates the advancement of new medical treatments and therapies. Contributes to the overall health research ecosystem.

Waste & Efficiency Indicators

Waste Risk Score: 50 / 10

Warning Flags

Potential for contract scope creep if not managed effectively.
Reliance on a single vendor for critical monitoring services.

Positive Signals

Awarded through full and open competition.
Supports vital NIH research objectives.
Experienced contractor in the field.

Sector Analysis

This contract falls within the Biotechnology Research and Development sector, which is characterized by significant government investment and a competitive landscape of CROs. Spending benchmarks for clinical monitoring services can vary widely based on trial complexity and duration.

Small Business Impact

The data indicates this contract was not awarded to a small business. While this specific award may not directly benefit SMBs, the broader NIH research ecosystem often involves subcontracting opportunities for smaller firms.

Oversight & Accountability

The National Institutes of Health (NIH) is responsible for overseeing this contract. Robust oversight will be crucial to ensure performance standards are met and funds are utilized effectively.

Related Government Programs

Research and Development in Biotechnology (except Nanobiotechnology)
Department of Health and Human Services Contracting
National Institutes of Health Programs

Risk Flags

Contract awarded through full and open competition.
Contractor is an established entity in the CRO market.
Supports critical NIH research and development activities.
Delivery order under a potentially larger IDIQ contract.
Contract duration is three years, allowing for sustained support.

Frequently Asked Questions

What is this federal contract paying for?

Department of Health and Human Services awarded $73.2 million to PPD DEVELOPMENT LP. NIAID CLINICAL SITE MONITORING (NCSM)

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 $73.2 million.

What is the period of performance?

Start: 2024-02-01. End: 2027-01-31.

What is the specific scope of work for clinical site monitoring under this contract, and how does it align with NIH's research priorities?

The contract likely encompasses a range of activities including site selection, initiation, routine monitoring, close-out, and ensuring adherence to protocols and regulations. Its alignment with NIH priorities would depend on the specific research areas funded by the agency, such as infectious diseases, cancer, or neuroscience, for which clinical trials are essential.

What are the key performance indicators (KPIs) for PPD Development LP, and how will their performance be measured to ensure value for money?

Key performance indicators would typically include metrics such as timely site visits, adherence to monitoring schedules, identification and resolution of data discrepancies, regulatory compliance rates, and overall quality of monitoring reports. Performance will likely be assessed through regular reviews, milestone achievement, and adherence to contractual obligations, ensuring the government receives the expected value.

Are there any potential risks associated with PPD Development LP's ability to deliver on this contract, given the duration and scope?

Potential risks could include resource availability, staff turnover, unforeseen challenges in clinical trial execution, or changes in regulatory requirements. The contract's duration of three years necessitates robust project management and contingency planning by PPD Development LP to mitigate these risks and ensure consistent, high-quality service delivery.

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: 75N93023R00008

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: $186,449,775

Exercised Options: $73,196,564

Current Obligation: $73,196,564

Actual Outlays: $33,476,066

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