Breaking Through Silos: Streamlining Site Workflows to Increase Patient Compliance

When managing complex cardiovascular, CNS, and oncology trials, clinical sites often navigate siloed applications to consolidate patient data. This operational burden delays the review of critical patient information, including eCOA completion, sensor data, and consent status, making it harder to identify which patients are falling behind or where immediate action is needed.

In this valuable session, we’ll share a practical roadmap for elevating patient care and reducing site burden. Join us to learn how to optimize clinical workflows, reduce data entry lag, and balance technology needs with real-world site capacity. You’ll discover strategies for using patient adherence data to drive a more efficient and successful trial experience.

 

We’ll explore:

  • How to help site staff spend less time chasing data and more time focused on high-value patient interactions and outcomes
  • Leverage AI and real-time data to gain a holistic view of patient activity, moving from reactive monitoring to proactive care
  • Ways to pinpoint and resolve common trial hurdles with flexible options that reduce burden for both patients and sites
  • Best practices to identify and act on early warning signs of patient disengagement to help protect trial timelines and data quality

INTERACTIVE SESSION The Traps of AI: Misrepresentation, Bias, and the Limits of Existing Data

Opening Question

“If your AI is trained on incomplete data, who is it really working for – and who is it leaving behind?” 

Key Focus Areas

  • How reliance on historical datasets creates systemic gaps, leaving underrepresented groups without sufficient data to ensure accurate AI outputs
  • Exploring the real-world impact of misrepresentation through live audience polling and scenario-based discussions
  • Challenging assumptions: where do we overtrust AI, and how aware are organisations of its limitations?
  • Practical steps to improve outcomes, including how to identify bias and push for more inclusive, representative data

Format

This session will be highly interactive, using live polling, audience Q&A, and scenario-led discussion to test perceptions and uncover blind spots. Attendees will respond to real-world scenarios, compare perspectives across the room, and collectively explore how bias and data gaps influence decision-making in practice.

Resilient Clinical Trial Teams: Using Mindfulness to Improve Focus, Communication, and Quality Under Pressure

Clinical trial teams today operate in increasingly complex, high-pressure environments involving cross-functional coordination, tight timelines, regulatory demands, vendor management, and constant operational decision-making. Over time, sustained cognitive overload and communication strain can impact focus, collaboration, leadership presence, decision-making, and overall quality of execution. This session explores how mindfulness can be practically applied within clinical operations environments to support more effective ways of working in high-demand, fast-paced clinical environments.

This session explores:

  • The science behind mindfulness and its relevance in high-pressure professional environments
  • What mindfulness is and how it supports focus, resilience, communication, and emotional regulation
  • Practical, doable, and immediately applicable mindfulness-based tools that can help clinical operations professionals strengthen focus, communication quality, resilience, decision-making, and sustained performance under pressure
  • This session will end with a group meditation

Operationalizing PROs and digital endpoints in early oncology: faster decisions, better data, stronger phase III

  • Embedding patient-reported outcomes (PROs) early to streamline oncology trial operations and control cost: How PROs in Phase I/II can deliver clearer tolerability and patient-experience data, supporting faster decisions and more efficient Phase III planning
  • Operationalizing digital endpoints (eCOA) for speed, quality, and patient-centricity: Practical strategies for configuring eCOA to accelerate startup, and reduce patient burden
  • Using digital endpoints to enable risk-based oversight and phase-to-phase continuity: How continuous, real-time eCOA data supports centralized/risk-based monitoring, and robustness of regulatory and scientific outcomes

Site Readiness: A Risk-Based, AI-Powered Model to Combat a Perfect Storm for Errors in Study Conduct

Studies are more complex, sites are less able to retain experienced staff, and the competition for patients is relentless. These pressures largely fall upon investigator sites and create a perfect storm for errors in study conduct. Data show that study errors cost sponsors approx. $500M for an average phase III trial, including the cost of post-approval delays.

This presentation will describe:

  • A risk-based strategy to improve site readiness, enabling sites to execute clinical trials with fewer errors,
  • How conventional practices in site training, information access, and point-of-performance support have been inadequate,  and why this presents sponsors with a clear opportunity to do better.
  • How sponsors expend significant funds to remediate errors after the fact yet overlook an array of sensible tactics to prevent errors.
  • How, with risk-based thinking and new AI-powered tools, sponsors can lower site errors, and thus expedite study timelines, improve data quality and generate savings with returns on investment in a range of 20:1 to 40:1, or higher.

ASK THE EXPERTS! Biotech Unlocked: Solving Clinical Operations Challenges Through Peer Insight

Biotech clinical operations teams face constant pressure – limited resources, tight timelines, and increasing complexity. This interactive session creates an open forum to share challenges, learn from peers, and uncover practical solutions that work in lean environments. 

Led by expert facilitators, the discussion will focus on real-world issues submitted anonymously by attendees. From operational bottlenecks to vendor management and resourcing, this is an opportunity to learn from others, avoid common mistakes, and leave with actionable ideas to drive progress. 

How the Session Will Work:

  • Scene Setting: Experts frame key challenges and trends
  • Anonymous Input (Slido): Attendees submit questions and challenges live
  • Peer Discussion: Open, honest sharing of experiences and solutions, with attendees also able to contribute answers and insights via Slido
  • Expert Takeaways: Key insights and practical actions to implement

Outcome: A candid, solution-focused discussion designed to help teams move faster and smarter.