SAM #FDA_716A2026

FDA Sole Source Data Retention and Analysis Services Contract to Harvard Pilgrim Health Care Inc.

This notice announces the FDA's intent to award a sole source, firm-fixed-price contract to Harvard Pilgrim Health Care Inc. (HPHCI) for specialized data retention and analysis services supporting pharmaceutical safety surveillance studies. - Agency & Buyer - Food and Drug Administration (FDA), Department of Health and Human Services (HHS) - Buyer: Rhoda Eniafe - Vendor & Sole Source Justification - Sole source to Harvard Pilgrim Health Care Inc. (HPHCI) - HPHCI is considered the only responsible source for these services - Scope of Work - Data retention of DP-specific summary datasets for PDUFA VII Pregnancy Safety and Negative Control studies - Optional reanalysis of up to 10 studies during the contract period - Deliverables include quarterly data lifecycle reviews, annual and final retention reports, and reanalysis reports as requested - Contract Structure & Period - Firm-fixed-price contract - Four-year base period: September 29, 2026 – September 28, 2030 - Optional add-on reanalysis services available during the contract - Key Requirements & Deliverables - Quarterly data lifecycle reviews (4 per year) - Annual data retention reports (4 total) - Final data retention report (due September 30, 2030) - Reanalysis reports as requested by FDA - Commercial Opportunity - No competing vendors are solicited due to sole source justification - No specific part numbers or quantities for products; focus is on specialized data services

Description

See attachments  for Intent Notice and Statement of Work

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