Archives: Agenda

FIRESIDE CHAT Quality Beyond Compliance: Embedding Risk-Based QA in Modern Clinical Trials

  • Embedding QA from day one: Shifting Quality from a reactive, inspection driven process to proactive design and execution
  • Leveraging RBQM frameworks and real time data analytics to anticipate issues, prioritize oversight, and make informed decisions
  • Integrating emerging technologies to streamline inspection readiness and improve data integrity
  • Applying quality tolerance limits (QTLs), analytics, and cross functional strategies to drive quality forward, reduce deviation risk, and strengthen regulatory confidence
  • Delivering future-ready QA practices aligned with ICH expectations to sustain a quality culture

Moderator: Lois Wallace, Senior Manager, Clinical Development, SERB Pharmaceuticals

Building a Flexible Site Liaison Model to Strengthen Partnerships, Align Stakeholders and Ensure Clinical Trials are Mutually Beneficial for Everyone

  • Bringing the site voice to study design: Partnering with investigators during protocol development to reduce amendments, deviations, and operational friction
  • Preventing problems before they happen: Using real-world site feedback to proactively adjust study design and execution
  • Acting as the connective driver between sponsor, CRO, and sites to ensure alignment, accountability, and continuity across the trial lifecycle
  • Lessons from a lean biotech: Stepping beyond defined roles and filling operational gaps, ensuring data flow and maintaining patient safety
  • Redefining success by measuring the unquantifiable impact of strong site relationships on recruitment, retention, and overall trial performance

Building Cross Connects: How Clinical Professionals Can Bridge Functions, Data, and AI to Lead the Transition

  • Building cross-functional fluency across clinical operations, biometrics, medical affairs and commercial to identify where AI can create value between functions
  • Developing boundary-spanning skills by learning enough of each function’s language to translate needs and priorities across teams
  • Testing ideas through rapid AI prototyping using LLMs and low-code tools to demonstrate what’s possible
  • Partnering across IT, data science and vendors to transform successful prototypes into governed, audit-ready solutions and move from AI-curious to leading an initiative within 90 days

From Zero To AI: Implementing and Scaling AI on a Budget for Smaller, Leaner Biotechs

  • Strategies for embedding AI tools into everyday workflows and gaining buy-in across cross-functional teams
  • Practical lessons for small biotech companies transitioning from experimentation to enterprise-level AI capabilities
  • Why data quality, governance, and integrated systems must be established before AI can deliver meaningful insights
  • Identifying realistic use cases where AI can support decision-making, forecasting, and operational oversight in drug development

Transforming IDMC Reports: Data Visualization Strategies to Enhance Safety Signal Detection, Protect Patients, and Align with FDA Draft Guidance

  • Traditional IDMC reports are struggling to keep pace with the complexity of modern clinical trials. Lengthy, table-heavy reports can make it difficult to identify emerging safety signals, a challenge recognized by both IDMC members and the FDA’s 2024 draft guidance.
  • This presentation explores how modern data visualization techniques, including targeted graphical displays and interactive dashboards, can transform interim data into clear, actionable insights. By improving the interpretation of safety trends, patient trajectories and clinically relevant deviations, visualization enables faster signal detection and more informed IDMC decision-making.
  • Attendees will discover practical strategies for modernizing IDMC reporting to improve patient safety, support regulatory expectations and enhance oversight throughout clinical development.