Benefits of Using an EDC System to Collect and Reconcile Serious Adverse Events


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Product Description

Collecting and reconciling adverse events (AEs) and serious adverse events (SAEs) data in clinical trials are mandated as good clinical practice and are therefore critical components for every clinical trial. But the process of collecting and reconciling AEs and SAEs remains extremely costly and time consuming. The reconciliation of AE data captured in a pharmaceutical company’s clinical study database with the SAEs reported in a safety database is a complex, thankless task that can involve weeks of effort, generate hundreds of queries to the investigator sites, and even delay the filing of an NDA until the process is completed. The difficulties stem from the same information being stored in two different systems, but there is a way to resolve the problem through electronic data capture (EDC), a platform to collect, view, reconcile, and report on clinical data…