Archives: Agenda

• How can sponsors and service providers start using guidance in totality instead of in silos?
• Overcoming the lack in consistency of regulations between regions and countries
• Collaborative ways to render it easier for regulators to accept multiregional trial data
• Developing shared expectations for trial conduct, acceptability of endpoints and data transparency

Chair: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData

• Building a partnership reciprocity between sites and sponsors to reduce discord and ensure sites are confident enough to succeed
• Is it fair to place the shortcomings of trial success on site performance?
• Developing an integrated strategic global site engagement model to transform site experience
• Enabling innovative approaches to drug development and delivering new treatments to patients faster
• Equipping sites with a clear and well-defined protocols to be able to best respond to sponsor needs

• In such sensitive environments, can you really trust AI to ensure the
• total compliance of your clinical trial?
• How can we overcome data shortages in smaller trials for the necessary algorithms
• Tangible use cases for successful implementation of AI in clinical trial data management
• Ascertaining an attractive ROI with AI investment
• Redefining biostatistics reporting as we traditionally know it with AI tools
• Unlocking new endpoints

• Feasibility figures true to delivery
• Regulatory dynamics for strategic advantages
• Collaborate with patients and physicians to enhance access to innovative therapies
• New study designs that accelerate development programs

• How early engagement can improve outcomes
• How do we speak the same language, no one size fits all approach
• Simplifying the complex, in a world of overwhelming outsourcing options and models

• Understand the need for collaborative partnerships with patient advocacy groups
• Discuss valuable insights these groups provide into the patient journey, clinical trial design, and study participation to reduce barriers faced by diverse patient populations
• Share best practices for leveraging advocacy groups to enhance patient recruitment and retention
• Explore how patient advocacy groups help align the objectives of clinical trials with broader diversity and inclusion goals

• Details of my two hybrid clinical trial participations
• What worked well during the trials
• Areas of improvement observed during/after the trials
• Recommendations for ensuring patient-centric trial design