Archives: Agenda

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

• 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

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.

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.

Drug development organizations are adopting new technologies, data platforms, and operating models at an accelerating pace, yet the success of these innovations often depends less on the tools themselves than on how people and teams absorb the change.

Drawing on ongoing research conducted with a working group of mid-to-large size pharmaceutical and biotech sponsors, this session will share fresh insights into how companies are managing the human side of innovation adoption.

Attendees will learn what is driving change across the industry, where change efforts most often stall, and which practical strategies sponsors are using to build readiness, encourage adoption, and turn new innovations into lasting practice.

With growing budget pressures and the expectation to do more with less, negotiation is an essential skill for clinical development professionals. This practical, interactive workshop will help attendees approach negotiations with greater confidence, uncover what matters to the other party, and explore ways to create value within budget constraints while building stronger working relationships.

Through everyday examples, negotiation role-play, and peer discussion, participants will practice asking effective questions, navigating “no,” and trading concessions thoughtfully. Moving beyond familiar contracting scenarios, attendees will explore approaches they can apply to CRO and vendor conversations, workplace discussions, and everyday negotiations.

Key Learning Points

• How to approach negotiations with clear goals, confidence, and an understanding of when to walk away
• Practical questions to uncover hidden priorities, understand constraints, and explore flexibility beyond the initial offer
• Strategies to trade value and negotiate favorable outcomes within budget constraints
• How to navigate resistance while building trust and maintaining productive working relationships
• Opportunities to practice negotiation techniques and identify lessons to apply immediately