Archives: Agenda

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Navigating biological material regulations

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

Liza Micioni, Director, Clinical Operations, Tris Pharma

ROUNDTABLE 4: Negotiation tips for emerging startups

• Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology
• Dive into the transformative power of AI and explore real-world applications reshaping cardiac care
• Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
• Uncover the revolutionary role of AI in interpreting cardiac data
• Review practical examples and case studies demonstrating effectiveness of continuous cardiac monitoring in clinical settings

• Understand the benefits, optimal use cases and best scenarios for master protocols
• Maximize trial operations with improved coordination and more sub-study opportunities
• Enhance data collection and sharing, broadening patient access to new therapies
• Navigate strategic relationships for safe and successful master protocol research

• Identify and eliminate “white space”.  Spot gaps between strategic planning and operational execution and apply techniques to streamline transitions across the clinical development lifecycle.
• Understand how early consulting and clinical pharmacology services work together to enhance strategy and execution. Understand when and how to engage to shape a cohesive development pathway, improve timing, and accelerate decision-making.
• Align scientific, regulatory, and clinical perspectives from the outset. Explore the benefits of integrated teams in a CRO setting to ensure continuity, reduce delays, and support end-to-end development.
• Connect strategic and operational elements across development stages. Gain practical insights into bridging planning, execution, and transition phases for smoother progression and better outcomes.

• Planning for a successful sponsor/CRO relationship
• Defining goals, priorities and metrics
• Considerations when contemplating a CRO transition
• Overview of common challenges and pitfalls in CRO transitions
• Developing a detailed transition plan to minimize disruptions and ensure continuity

• Understand the key points of recent FDA guidance aimed at enhancing diversity and equity in clinical trials
• Discuss how recent FDA guidance supports patient optionality in clinical trials, especially for underrepresented populations
• Identify actionable strategies for integrating FDA guidance into clinical trial designs to achieve diversity and innovation goals
• Explore the potential impact of FDA guidance on future clinical trials, with an emphasis on patient-centricity and inclusivity

• Ensuring your trial is both cost-conscious and efficient without compromising on quality
• Techniques, processes and technology to improve forecasting and budgeting
• Avoiding common mistakes to keep your clinical trial budget on track