Archives: Agenda

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

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 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