Archives: Agenda

• Explain how Agentic AI elevates clinical data management beyond rule-based automation
• Understand the role of reasoning models in enabling autonomous decision-making within clinical trials
• Identify key ways AI agents can improve data oversight, reduce operational burdens, and support regulatory compliance
• Explore real-world considerations for deploying Agentic AI within existing clinical workflows

• Addressing key challenges small biotech’s face to minimize roadblocks in clinical data management
• Integrating strategies to ensure streamlined clinical data management processes
• Leveraging tools and innovation to ensure quality data collection that reduces study timelines.

• Explore how a connected data experience breaks down data silos, optimizes workflows, and delivers actionable insights for clinical data and analytics teams
• Discover practical applications of AI-powered automation to make higher quality data available sooner for analysis and regulatory submission
• Learn how leading organizations leverage these solutions to achieve a robust clinical data strategy and faster, more cost-effective clinical development

• Why ATR, why now? Regulatory context (ICH_E6) and the quality/patient-safety imperative
• Risk-based ATR: Principles, assessment methods, and prioritization in audit trail review
• Practical use cases: What to look for, signals to flag, and how to interpret findings
• Systems & enablement: Key platforms, tools, analytics, and workflows that operationalize ATR

• Overviewing current approaches and trends within clinical data management
• Assessing challenges and identifying solutions
• Understanding the where the industry is heading to curb competition

Clinical trials have a notoriously high failure rate. Evidence shows that the inclusion of effective biomarkers can double the success rate of clinical trials. This presentation explores precision medicine technologies that can serve as companion diagnostics for both small and larger pharmaceutical companies. It will explain how such companion diagnostic can help to improve patient selection, strengthen evidence generation, and increase approval rates for anti-inflammatory drugs. It will also highlight data-driven strategies that enable smarter trial design and combinational biomarkers can enhance success rates in drug development for conditions such as inflammatory bowel disease (IBD) and rheumatoid arthritis (RA)