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The Department of Health and Human Services, through the Centers for Disease Control and Prevention, is procuring sole-source records management and storage services for clinical trial files to ensure compliance with FDA and EMA regulatory requirements, including secure climate-controlled storage, chain of custody, and an inventory system for archiving, retrieval, and disposition.
Providing secure, climate-controlled storage and inventory management for clinical trial files with full chain of custody to meet FDA and EMA regulatory standards for long-term archiving, ad-hoc retrieval, and final disposition.
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. Robin Meyer Contracting . Humphrey Building 200 Independence Avenue, SW (No Street Address
2) Washington, DC 20201 US to this opportunity.
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