Clinical Technologies Webinars

  1. Clinical Leader Smart Sourcing Solutions Expo: Why Castor? 9/9/2025

    How do Agentic workflows (with human oversight) unlock data from patient-mediated medical records and convert clinical data and lab PDFs into traceable, submission-ready study data?

  2. Clinical Leader Smart Sourcing Solutions Expo: Retention By Design 9/9/2025

    Enhance participant retention through intuitive UX and real-time site support tools, while seamlessly integrating with IRT, EDC, and third-party platforms.

  3. Accelerate Clinical Insights: From Data Deluge To Decisions In Minutes 9/5/2025

    Unlock clinical trial insights in minutes, not months. Discover a platform that streamlines data review with AI-powered listings and visualizations to empower faster, smarter decisions.

  4. Breaking Barriers With PCR: Innovative Solutions For Clinical Trial Success 9/3/2025

    This presentation brings together experts from Precision for Medicine, Avidity Biosciences, and Indaptus Therapeutics to examine the expanding role of PCR-based molecular monitoring.

  5. Stop Protocol Amendments Before They Start 8/22/2025

    Julie Smiley of CDISC explains how digital protocols can revolutionize protocol feasibility by running eligibility criteria through EHR systems to identify potential patient populations up front. She discusses how this approach addresses the major cause of protocol amendments — patients not meeting eligibility criteria — and supports quality by design principles.

  6. Breaking Free from 20 Years of 'Do Everything' Mentality 8/22/2025

    Joe Fitzgerald of Regeneron provides historical context for the regulatory evolution from ICH E6's original focus on thorough, consistent execution to the current emphasis on QbD. He explains how the industry is shifting from 100% SDV and exhaustive edit checks to early detection and prevention of high-impact errors, emphasizing the mindset change required for successful implementation.

  7. How Digital Protocols Are Eliminating Manual Errors 8/22/2025

    Julie Smiley, VP of Data Sciences at CDISC, reviews CDISC's new 360i initiative, explaining how it transforms standards into structured executable metadata to automate clinical development processes. She discusses the USDM (Unified Study Definitions Model) and how digital protocols reduce ambiguity and minimize manual errors throughout the clinical trial lifecycle.

  8. We Need Better Risk-Management-Strategy Communication 8/22/2025

    Ann Hale of Abbvie addresses the critical need for better communication with clinical trial sites about sponsor risk-management strategies. She discusses how sponsors need to explain their centralized monitoring approaches, anomaly detection methods, and what sites can expect in terms of queries and monitoring activities.

  9. A Real-World ICH E6 R3 Implementation Example 8/22/2025

    Joe Fitzgerald, head of clinical data processing and reporting at Regeneron, provides a concrete example of operationalizing ICH E6 R3's risk proportionate principles using a Phase 3 oncology trial. He walks through the complete framework: Critical to Quality (CT scans within ±7 days), Key Risk Indicators (percentage of late scans), Quality Tolerance Limits (less than 10% cumulative late), and planned responses — making abstract concepts tangible and actionable.

  10. Why AbbVie Moved Risk Assessment to the Draft Protocol Stage 8/22/2025

    Ann Hale, Head of Study Risk Management and Central Monitoring at AbbVie, discusses the company's shift toward conducting risk assessments earlier in the protocol development process using cross-functional teams. She emphasizes the importance of data criticality assessments and asking the fundamental question "What is truly critical?" to identify genuine showstoppers versus nice-to-have data points.