Archives: Agenda

• Digital patient engagement tools drive compliance: a web-based electronic patient-reported outcome platform together with an automated reminder system and multi-device accessibility enabled 98% of participants to complete visits with minimal follow-up, demonstrating how digital tools can engage diverse patient populations, including older demographics, while reducing site workload
• Integrated electronic payment system eliminates barriers: connecting an ePRO platform with digital payment solutions through API integrations ensures immediate participant compensation with multiple payment options (PayPal, Venmo, direct deposit), achieving 97%+ payment claim rates and preventing the participant dropout issues common with traditional prepaid card systems

• Comparing validated use cases across feasibility, monitoring, and documentation
• Defining guardrails for privacy, bias, and human oversight
• Identifying where AI adoption increases risk more than it reduces work

Moderator

Peter Horwich, President, Lot 10

• Translating cybersecurity expectations into clinical risk and user impact
• Planning evidence for resilience claims and update pathways
• Preparing submission-ready documentation and traceability

• Reducing friction in consent and re-consent while protecting comprehension
• Designing participant communications that improve retention
• Auditing usability and documentation to avoid avoidable noncompliance

Chair: Charlie Whelan, Senior Director of Consulting, Medical Devices, GlobalData

• Avoiding over-collection of data that delays timelines without adding value
• Understanding where regulators expect more vs where lean approaches are acceptable
• Sharing real examples of underpowered vs overengineered studies and their impact

Moderator

Aneela Idnani, President, HabitAware

• Synchronizing the sponsor, CRO, and site
• Streamlining communication via defined roles and responsibilities
• Stabilizing study teams through proactive, strategic personnel continuity
• Empowering sites with transparent practices and user-friendly solutions