Long-Term Data Retention for Pharmaceutical Safety Studies

The contract pertains to the secure, long-term storage and management of de-identified, summary-level pharmaceutical safety datasets, ensuring robust data lifecycle management from ingestion through archival and eventual disposition. It requires strict adherence to data integrity protocols, comprehensive access control mechanisms, and continuous compliance with regulatory standards governing pharmaceutical safety data, particularly those aligned with FDA expectations. The provider must support secure handling, auditability, and controlled access to data for authorized stakeholders while maintaining confidentiality and preventing re-identification risks. Performance is centered at Silver Spring, Maryland, with the work governed under NAICS code 518210 for data processing and hosting services. The agreement is structured as a subcontract under the FDA Negotiated Contracts Branch of the Department of Health and Human Services, with a response deadline of July 30, 2026, and a posted date of July 17, 2026. The contract emphasizes enduring data stewardship capabilities, including infrastructure resilience, automated retention policies, and reporting features that facilitate regulatory oversight and scientific analysis, without the need for raw or patient-identifiable data.