Archives: Agenda

• Embedding QbD principles across the clinical supply lifecycle to proactively manage risks
• Strengthening risk-based quality management for compliance and supply continuity
• Preparing quality-driven supply strategies for advanced therapies and complex trials

• Key operational lessons learned from conducting large-scale vaccine trials in (LMICs)
• Balancing rapid trial execution with regulatory compliance and Good Clinical Practice
• Strategies for successful patient recruitment, retention, and community engagement in resource-limited settings
• Ensuring data quality, oversight, and risk management across geographically dispersed trial sites

• Realistic AI applications in protocol drafting, demand forecasting and inventory management
• Keeping pace with fast-moving AI development while maintaining trial integrity
• AI, data and the changing role of the CRO/vendor

• Design early Korean oncology studies around the evidence needed for the next decision, including patient selection, dose and schedule, biomarkers, safety, and meaningful clinical activity.
• Assess whether the results can inform development beyond Korea by considering differences in prior treatment and standard of care, PK and exposure, assay and product comparability, and data quality.
• Use the emerging evidence to decide when to strengthen proof of concept in Korea, conduct a focused study in another region, or expand into a multiregional trial.

• Asia-Pacific emerging as the fastest-growing region for clinical trial outsourcing, with India positioned at the center of that shift
• Cost-competitive infrastructure without compromising data quality or regulatory rigor
• Rethinking the strategy: from transactional to strategic

• AI-Powered Data Capture: Transforming EDC from Data Collection to Intelligent Data Acquisition
• Predictive Data Quality: Leveraging AI for Proactive Risk Detection and Quality Oversight
• The Future Data Manager: From Data Custodian to Strategic Intelligence Partner