Archives: Agenda

• Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
• Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
• Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
• Addressing concerns at the protocol and ICF development phase

• What forced me to think strategically about clinical research training methodology
• Gaps & Risks of ‘check-the-box’ training
• Initial impact of Simulation-Based training on risk mitigation, Site time, Satisfaction, Enrollment and Quality
• Advances in Simulation-Based training that enhance site and patient engagement as well as optimize protocols

• Considerations during EDC vendor selection
• Operational and technical considerations when implementing Patient Reported Outcomes measures
• Outsourced/Hybrid/Insourced EDC development models- cost and operational considerations

• Identifying outsourcing opportunities and pitfalls to avoid that can be addressed through AI driven solutions: timeline standards, document prep and system utilization
• Developing operationally, process and system driven AI models to support clinical operations and outsourcing: what can be streamlined?
• Integrating AI insights into outsourcing strategy to drive speed, quality and cost effectiveness: timelines, project management and reconciliation

• Collecting and integrating supportive data sources for complimentary patient insights
• Understanding the regulatory landscape around RWE and how to navigate this efficiently
• Ensuring data quality, privacy and regulatory compliance in RWE initiatives

• Developing relationships with advocacy groups and patient communities from early stages
• How does patient advocacy differ at biotechs vs large pharma?
• Integrating patient insights into your study to ensure patients remain the priority throughout your trial

MODERATOR Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

• Maximize the value of existing patient involvement efforts by “translating” patient advisory board insights into participant-facing materials
• Meet growing regulatory expectations for patient involvement in participant materials development
• Implement a co-development approach with patients and advisors review
• Internal planning tips for timelines, stakeholder engagement, and IRB submission strategies
• Best practices in health literacy to ensure clarity, trust, and accessibility