"This is the best use of my time to remain current with what is going on in the industry."
Wearables, sensors, personal devices are used in data collection for clinical trials - sponsors have limited control and industry standards are needed. New constructs are required for the governance of their use in clinical trials. With the rapid adoption in the use of personal devices in clinical trials, the industry must be able to establish a clear scope of responsibilities among all stakeholders.
This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators. Address the problem of generic regulations and create industry guidelines more tangible and actionable.
To... develop standard approaches, practices, expectations - generate minimum standards for us to meet the opinions of global regulators
By... leveraging the experiences and current ePRO best practices and focus on ALCOA compliance
In order to... have a set of guidelines and actions that make the general guidance provided to date more tangible for industry adoption
Europe/Hybrid Autumn Workshop, October 27-29, 2026, Zurich, Switzerland, hosted by BSI Software
eCF Webinar November: FDA warning letters for audit trail analytics
FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.