SAM #75D30126R73442

Sole Source Records Management/Storage Services for CDC Clinical Trial Files

This opportunity involves the Centers for Disease Control and Prevention (CDC) seeking specialized records management and storage services for clinical trial files: - The CDC, under the Department of Health and Human Services (HHS), plans a sole source, firm fixed price purchase order to IRON MOUNTAIN INFORMATION MANAGEMENT LLC. - Services required include: - Secure, climate-controlled storage of clinical trial files - Maintenance of chain of custody for all records - Inventory filing system supporting detailed archiving, ad-hoc retrieval, and final disposition - Compliance with regulatory requirements from the FDA and European Medicines Agency (EMA) - IRON MOUNTAIN INFORMATION MANAGEMENT LLC is identified as the only responsible source capable of meeting all requirements. - No specific quantities or part numbers are listed, as this is a service-based procurement. - The place of performance is in Georgia, with the CDC's main address at 1600 Clifton Road, Atlanta, GA 30333, and a performance ZIP code of 30336. - Other responsible vendors may submit capability statements or quotations for consideration.

Description

The Centers for Disease Control and Prevention intends to award a sole source firm fixed price purchase order to IRON MOUNTAIN INFORMATION MANAGEMENT LLC for Records Management/Storage Services, identified, assessed, and selected as the sole eligible vendor for meeting all criteria required for the long-term maintenance of clinical trial files according to the regulatory requirements defined by the FDA and the European Medicines Agency (EMA). In addition to providing secure storage and temperature control, Iron Mountain uniquely meets the requirements for maintaining the chain of custody of clinical trial files and provides an inventory filing system which supports the meticulous archiving, ad-hoc retrieval, and final disposition required for these files.  This contract action is for climate-controlled storage services for which the Government intends to solicit and negotiate with only one source under the authority of 41 U.S.C.3304(a)(1), Only one responsible source and no other supplies or services will satisfy agency requirements. This notice of intent is not a request for competitive quotations; however, all quotations/responses received within 5 days of the issuance of this notice shall be considered by the government.  A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government.  Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.  Any quotation/response should be emailed to contract specialist Robin C. Meyer at email rcm2@cdc.gov by April 28, 2026, NLT noon. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.

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