In this webinar...
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.
- Determine key drivers for the use of technology to manage clinical trial disclosures processes
- Implement efficiencies and consistencies gained from enabling reuse of protocol and results summary content across regions
- Understand the importance of integrating drug and submission-level metrics into disclosures systems
- Identify system features and functionality that are key to achieving global compliance
- Recognize the importance of automated workflow management to manage the disclosures life cycle
- Kasim McLain, Manager, Disclosure Services, MMS offering TrialAssure®
- Peggy Zorn, MS, MBA, Associate Director, Regulatory Affairs, Submissions and Transparency, MMS offering TrialAssure®
- Gitta Irmer, MS, Associate Director, Data Quality and Standards, Eisai
- Zach Weingarden, MS, Product Solutions Manager, TrialAssure®, MMS