Records Management/Storage Services

The Centers for Disease Control and Prevention is awarding a sole-source firm-fixed price purchase order to Iron Mountain Information Management LLC for records management and storage services critical to the long-term preservation of clinical trial files in compliance with FDA and European Medicines Agency regulations. This acquisition is justified under FAR 6.302-1 due to Iron Mountain’s uniquely qualified ability to provide climate-controlled, tamper-proof storage with a fully documented chain of custody, an inventory system enabling precise archiving and ad-hoc retrieval, and facilities certified to meet international regulatory standards. The services will be performed at Iron Mountain’s secured vault in Atlanta, Georgia, where approximately 500 sealed document boxes containing clinical trial participant records will be stored through 2034, ensuring audit readiness for FDA, EMA, and Pharmacy Board of Sierra Leone inspections. The contract includes one base year and four option periods, extending performance through May 2, 2026, and builds upon a previously active contract initiated in 2023. No other vendor can satisfy the technical, regulatory, and operational requirements for secure, compliant handling of these records, making competition inappropriate. The contract does not specify exact pricing or line-item costs but is structured under GSA Schedule and Open Market ordering mechanisms with a firm-fixed price model to control costs and mitigate financial risk. Packaging must ensure secure transport and storage integrity without requiring MIL-STD specifications, relying instead on proprietary sealed-box systems and electronic tracking implied by the inventory management infrastructure. While no formal contract clauses, evaluation factors, or detailed inspection protocols are listed in the available documentation, performance is governed by adherence to regulatory frameworks including 21 CFR Part 11 and Good Clinical Practice guidelines. Payment and contracting administration oversight are managed by the Department of Health and Human Services in Washington, DC, with Robin Meyer serving as the primary point of contact. No key personnel, security clearances, or organizational conflict of interest mitigation plans are required, as the justification rests entirely on Iron Mountain’s singular capability to deliver the necessary compliant storage environment.