Archives: Agenda

Support teams are often seen as reactive problem-solvers—but what happens when they’re embedded early in the trial lifecycle? This session explores how technical support can play a proactive role in study success. We’ll discuss how early involvement in processes like the Study Maintenance Plan and Go-Live allows support teams to anticipate challenges, prepare sponsors and sites, and respond more effectively when issues arise. Join us for a practical conversation on how collaboration and foresight can make support a strategic asset in clinical trial delivery.

• Classifying clinical materials correctly to avoid delays or unexpected costs
• Collaborating with brokers and logistics partners to ensure compliant, efficient importation
• Determining duty rates and entry rates for different types of clinical trial materials and products
• Applying for duty exemptions: are you eligible?

• Evaluating sourcing, shelf-life and regulatory constraints for high risk items
• Mapping global supply chain dependencies and transit vulnerabilities
• Implementing strategies to mitigate against supply chain risk
• Collaborating cross-functionally to align risk assessment with trial timelines and priorities

• Designing flexible IRT systems to accommodate multiple dose levels and protocol adaptations
• Forecasting clinical supply needs amid uncertainty in dosing, cohorts and timelines
• Collaborating across functions to align IRT, supply and clinical execution
• Applying lessons learned from a real world CNS program with high complexity and unpredictability

MODERATOR: Luiz Barberini, Head of External Manufacturing, Latin America, Bayer

• Designing your comparator sourcing strategy: key factors to consider for your clinical trial
• Exploring strategies for reliable and cost-effective sourcing: what solutions are available?
• Addressing regulatory considerations and compliance challenges for comparator sourcing both in the US and from overseas
• Leveraging technology and data analytics to streamline comparator sourcing processes

• Strategies for reducing clinical supply waste while ensuring patient needs are met
• Digital tools that enhance real-time visibility into supply shipments and their status
• Operational innovations that enable faster timelines without increasing risk
• Practical approaches to aligning supply chain efficiency with clinical trial demand

• The basics of drug substance manufacturing and what drives uncertainty in yields, especially in early phase production
• Recommendations and tactics for how supply chain planners should coordinate early and often with counterparts in CMC and manufacturing to stay abreast of expected yields, lead times, sampling requirements
• Understanding risks

• Data-driven insights: utilizing data analytics for informed forecasting decisions
• The importance of remaining flexible to adapt to changing trial dynamics and demands
• Proactive risk management: identifying and mitigating potential obstacles to streamline forecasting processes
• Effective forecasting in order to reduce waste, cost and carbon footprint