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FDA Guidance on Clinical Systems |
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| Clinical Data Archive
Explore Consulting builds secure, controlled access interfaces to clinical data. The original Clinical Data Management Systems used to process data during the clinical trial, analysis, and publishing processes can be retired to end maintenance costs. To find out more about how Explore Consulting can help, contact us. |
After
clinical trials are complete and before the record retention period
ends, data frequently sits dormant and unused in a clinical data
management system. Frequent organizational changes (mergers, acquisitions,
outsourcing), technology changes (software versions, outsourced
services), standards evolution (CDISC, XML, 21CFR11), and staff
turnover make it difficult to keep this data available in a controlled
system with an audit trail of access and changes.