Archives: Agenda

• Operational Strain: Traditional, manual audit trail reviews across siloed clinical systems drain clinical operations resources, delay study close-out, and increase regulatory compliance risks.
• Unified Ingestion: Workflow automation continuously ingests disparate digital logs from EDC, eCOA, and IRT systems into a single, standardized operational layer.
• Intelligent Traceability: Autonomous AI agents map complex patient data journeys across the digital network, automatically flagging data anomalies and out-of-sequence transactions.
• Business Impact: Shifting from reactive sampling to automated, comprehensive oversight slashes inspection-readiness timelines, optimizes trial oversight, and guarantees ironclad data integrity.

• Baseline metabolic heterogeneity can be measured and may contribute to differences in treatment response.
• A single blood sample provides a quantitative profile of six key redox metabolites.
• Redox profiling can support patient stratification and monitoring of treatment-related metabolic changes.
• The analysis can be integrated into clinical trials using a small aliquot of routinely collected blood, with centralized analysis and minimal impact on existing workflows.

• The evolution of AI in clinical trial operations and the problems it can solve
• Choosing safe, transparent and fit-for-purpose AI
• Moving from fragmented tools to unified, traceable trial infrastructure
• Real-world impact, adoption and ROI through case studies

• Decentralized research models in neuroscience: Explore how virtual site models and structural innovations are expanding the breadth and diversity of physician participation in real world studies.
• Generating robust Alzheimer’s Disease RWE: A look at ecosystem-wide challenges in AD real world evidence generation, including study design considerations from the INITIATE-SC program.
• Addressing Phase IV research barriers through innovative tactics: Eisai and SiteRx share a joint perspective on how decentralized approaches can overcome structural challenges unique to neuroscience post-marketing research.

• A real-world case study demonstrating where AI has tangibly reduced costs or accelerated timelines
• How AI was implemented in practice (e.g. patient recruitment, data cleaning, site selection) and what made it successful
• Breaking down the ROI: cost savings, efficiency gains, and operational impact
• Lessons learned: where AI delivered value vs where it fell short—and how to replicate success in smaller biotech settings

There are many aspects to moving from early research to clinical delivery under one roof. This session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

• Building and scaling a clinical operations function
• Talent, structure, and service provider strategy
• In-house vs. outsourced clinical deliver: Key considerations for clinical trial delivery, from build decisions to patient recruitment

• Why finding the right site is only the beginning of clinical trial success
• How AI and human expertise work together to accelerate study start-up
• Proven approaches to reducing site burden and improving engagement
• Practical lessons for building more predictable, high-performing site networks

• Meet the #1 AI CRO: Deep Intelligent Pharma Overview
• Industry Pain Points: High Clinical Development Failure
• DIP’s AI-Human Hybrid Approach to Clinical Development
• Real-World Success Stories & Proven Results

• The surge of high-quality assets from China: what’s driving the acceleration?
• Licensing trends: why Western pharma is increasingly looking East
• Regulatory implications: how the FDA and global bodies are adapting
• Geopolitics vs innovation: balancing risk, access, and opportunity in trial strategy

China’s life sciences sector is rapidly reshaping the global biotech landscape, with a growing pipeline of high-quality assets attracting significant international investment and licensing activity. This session will explore how this shift is impacting clinical development strategies, regulatory frameworks, and competitive dynamics. From navigating cross-border partnerships to understanding evolving FDA perspectives, join industry leaders as they unpack what this means for outsourcing, trial design, and the future of global collaboration.