Archives: Agenda

• Choosing the “right” CRO for your study and ensuring you get the “A” team or the team you were promised: and building a positive relationship with them
• Clearly identifying who is responsible for each action item; especially items that are part of study start up (site ID, feasibility, site qualification) and how to proceed efficiently
• Establishing realistic timelines and practicing constant communication to avoid timelines slipping
• Keeping patients in mind when designing the protocol
• Utilizing updated technology: A look at a recently adopted eISF system and potentially adopting a RBQM system
• Using sites with a diverse population and promising constant communication with them
• Sending an initial budget template early on to help streamline the budget process and identify sites that may not fit within the study budget early on.

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• Why inclusive research is a business and clinical imperative
• How to continue the work in the current climate
• Increasing focus on US enrollment
• Five principles of data driven inclusive research

• Engaging right CROs/CDMOs
• GXP compliance
• Budget, timeline, and conflicts

• 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

• Move past the hype: Treat AI as a strategic enabler, not a technical hurdle.
• Conversing with data: Use AI to interact with insights rather than just manage information.
• Practical toolkit: Combine everyday assistants with specialized models for rapid document synthesis and cross-referencing.
• Incremental adoption: Integrate AI capabilities gradually without overwhelming learning requirements.
• Outcome: Empower teams to enhance expertise and decision-making with AI.