Clinical Technologies Webinars

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Navigating Multisite Trials 8/21/2025

    Overcome data challenges in multisite clinical trials with strategies that ensure consistency, regulatory compliance, and accurate, reliable results.

  7. Castor eConsent: Site View 8/21/2025

    Study coordinators aim to enroll participants efficiently through a partnership that leverages direct-to-patient marketing to streamline recruitment.

  8. Beyond The Data Deluge: Immune Profiling In Early Immuno-Oncology Trials 8/14/2025

    This presentation explores how to design effective immune monitoring for early-phase immuno-oncology trials, focusing on strategic platform selection, cost, and operational feasibility.

  9. Comprehensive Reporting Across Industries With NSAW 8/13/2025

    In this presentation, Snehal Patel and Trevor Flaxman share their expertise with NetSuite to help you better understand data analytics and using the process to your full advantage.

  10. Transforming Drug Development With Statistical Science 8/12/2025

    Explore how statistical science and computational biology can accelerate drug development. Learn how innovative trial designs and Bayesian statistics can lead to more efficient and successful clinical trials.