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Regulations related to clinical trial disclosures and transparency are becoming increasingly complex due to recent legislation such as the NIH Final Rule, EU 536/2014 Clinical Trial Regulation, and other regional directives. These pieces of legislation have expanded and enhanced disclosure requirements, mandating that the pharmaceutical industry share an ever-growing set of data in a more transparent fashion. Managing detailed regulatory and content requirements across regions as well as tracking dates for mandatory registrations, study updates, and results posting requires sophisticated tools and systems to ensure compliance, data quality, and reporting efficiency. Systems that can manage complex logic related to regulatory requirements across regions and produce accurate, study-level projections of mandatory activities and associated timelines are becoming increasingly necessary to ensure compliance. These systems also need to have strong content management functionality to enable reuse across registries, the ability to integrate with existing regulatory and clinical data, as well as workflow functionality to facilitate efficient interaction between clinical study teams and disclosures staff throughout the life cycle of the study.

As transparency requirements and outputs grow beyond clinical trial registry databases to include redacted documents, lay summaries, anonymized datasets, and more, disclosures systems need to evolve to support an increasingly complex and multi-faceted environment.

Continuing Education Credits are not available for this event.