Records Management/Storage Services

The Centers for Disease Control and Prevention (CDC) is seeking a sole source vendor to provide records management and storage services for clinical trial files. The selected vendor will be responsible for providing off-site, secure storage for hard-copy documents, including approximately 500 sealed/tamper-proof boxes of paper clinical trial participant files. The vendor must meet the regulatory requirements defined by the FDA and the European Medicines Agency (EMA) and provide a turnkey solution for off-site data protection, secure protected transport receiving, archiving, and record storage. The contract will be for a period of one base year and four option periods. • The vendor must provide climate-controlled storage services. • The vendor must maintain the chain of custody of clinical trial files. • The vendor must provide an inventory filing system that supports meticulous archiving, ad-hoc retrieval, and final disposition of the files. • The vendor must ensure the preservation of the files while stored and accommodate visitors in case of audits by regulatory bodies.