SAM #75D30126C21013

Sole Source Secure Storage Services for CDC Clinical Trial Files

The Centers for Disease Control and Prevention (CDC) is procuring sole source records management and storage services for clinical trial files. - Sole source contract awarded to Iron Mountain Information Management LLC - Services include secure, climate-controlled storage of approximately 500 sealed/tamper-proof boxes of clinical trial participant files - Storage must comply with FDA and European Medicines Agency (EMA) regulatory requirements - Chain of custody and advanced inventory management for archiving, retrieval, and final disposition - Contract is firm-fixed-price, estimated at $387,828.59 - Period of performance covers one base year and four option years, with files maintained until 2034 - Place of performance is Iron Mountain's facility in Atlanta, GA (ZIP 30336) - CDC contracting office located at Hubert H. Humphrey Building, Washington, DC - Iron Mountain identified as the only vendor capable of meeting all requirements

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. 

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