Sponsor Oversight Responsibilities for IRT:
Proactive Management that Meets Regulatory Scrutiny
About this webinar
As the use of eClinical technology grows, regulatory agencies are increasing their expectations of trial sponsors to demonstrate oversight and active management of their Interactive Response Technology (IRT). Many organizations have struggled to find a balance between effectiveness and efficiency in this regard, as the “correct strategy” is subjective.
In this free webinar, learn the significance of User Acceptance Testing (UAT) as a part of vendor oversight, along with what you really need to know to leverage or improve your current practices. The featured speakers will not only discuss efficient methods that will ultimately help ease stress when achieving IRT milestones, but the benefits of maintaining an IRT that’s inspection-ready. All of which can be done while protecting patients and keeping sponsors and their suppliers aligned.
Who should attend
- Study Leads/Managers
- Vendor Managers
- IRT Experts
- Medication/Supply Managers
- Systems Validation personnel
What you will learn
- The benefits of and maintaining an inspection-ready IRT
- How to ease your stress when achieving IRT milestones
- Sponsor oversight and the relationship to UAT
- Tips for performing an effective UAT
Featured Speakers
Bob Weney
Bob Weney has 13 years of experience with various aspects of IRT system implementations in clinical trials, with seven of the thirteen being focused on testing practices and strategies. He is currently overseeing teams responsible for the development, testing and delivery of IRT systems.
Matt Lowrie
Matt Lowrie has 17 years of experience within the pharmaceutical industry and is responsible for regulatory compliance, inspections and risk management in his role. He has supported hundreds of regulatory inspections and continues to work with Almac’s clients on implementing best practices.
Partner for this event
Almac
Almac Clinical Technologies: For over 20 years and more than 2,000 clinical trials, Almac Clinical Technologies have been at the forefront of innovation for technology-enabled solutions in the highly-regulated biopharmaceutical industry. Almac Clinical Technologies are the only IXRS® Interactive Response Technology software supplier who were successfully audited by the FDA.
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