Archives: Agenda

• How is the industry approaching diversity and what should the primary focus be?
• Increasing accessibility to trials whilst simultaneously maintaining an appropriate level of patient safety
• Assessing the link between restrictive eligibility criteria and rates of serious adverse events to make informed decisions on expanding exclusion conditions
• Alternative solutions to improve patient numbers amidst pressures to hit recruitment milestones
• How have increased pressures of patient recruitment lead to the questioning of traditional enrollment methods?

Chair: Cathy Scharf, Patient Advocate, Patient Advocates of the East Bay

• Understanding UDI requirements across regions
• Implementing UDI systems for traceability and safety
• Leveraging UDI data for operational efficiency

• Automating Adverse Event Evaluations: Enhancing speed and accuracy using AI.
• Streamlining Clinical Protocol Training: Efficiently generating consistent training materials with AI.
• Improving Medical Coding: Utilizing AI for accurate adverse event classification and regulatory compliance.
• Reducing cycle times and operational costs and enhancing data accuracy to
  better clinical trial results

• How to create a patient-centric clinical protocol to obtain the necessary data and validate your primary objective
• How biotechs are using tools internally and managing different stakeholders to pressure test themselves to have less complicated protocols
• Looking at ways to ensure patients don’t go through a burdensome process
• Championing collaborative sites for a streamlined trial

• Prioritizing your organizational structure and goals
• Key considerations for developing a bespoke outsourcing framework
• Building resilient outsourcing strategies that align with future clinical development needs

• Evolution of CRO FSP models
• Balancing growth and quality in a hybrid model
• The future of scaling and offshore integration

• How do we look at data transparency issues when scaling AI?
• Case study on AI rights and a look at recently released survey discussing where things need to change
• Without GDPR, what can be done to protect patients regarding data sovereignty?
• Delving into the unique and amplified challenges for AI risk assessment
• How we can effectively leverage AI in our heavily regulated environment?