Archives: Agenda

• Addressing site burden during study start-up, recognising that sponsors often assume infrastructure and systems are already in place, when the reality can vary significantly between sites.
• Exploring how increasing protocol complexity is driving operational challenges and requiring sites to develop more creative and adaptable approaches to trial execution.
• Strengthening collaboration between sites, sponsors, and CROs to improve communication, efficiency, and study delivery.
• Creating an environment of trust where sites feel comfortable raising concerns around timelines, resources, and operational complexities without fear of losing future opportunities.
• Identifying practical strategies to reduce administrative burden while maintaining quality, compliance, and patient-focused outcomes.

Drawing on practical CRO-side experience working within collaborative, multi-partner study models, this session will explore:

• How biotech sponsors can build an effective operating model when multiple CROs, specialized vendors, and regional partners are involved in the same study
• Practical case studies showing where multi-partner trials can break down — particularly around decision ownership, cross-partner interfaces, and the addition of new regions or capabilities
• How focused visibility, clear ownership, and active coordination can help multiple partners work as one study team without increasing the burden on lean sponsor organizations

• Examine why faster, more inclusive clinical development matters: helping patients access trials and medicines sooner while enabling the system to evaluate more potential therapies.
• Discuss public FDA priorities, pilots, and opportunities for constructive stakeholder input that may shape the next phase of clinical development.
• Translate those signals into practical considerations for trial design and delivery, including feasibility, participant representation, site burden, evidence quality, and data reliability.

Clinical supply forecasting and RTSM systems have traditionally operated as separate entities. This session examines the compelling case for unifying these systems and the benefits that can accrue. Is this the future of clinical supply management? What does this imply for your studies.

In this session we will look at:

• Operational challenges encountered in forecasting and RTSM systems seen as discrete solutions

• Common integration models and why they fall short

• The unified solution and its closed-loop capabilities

• Business benefits including efficiency; cost savings and risk reduction

Join us to explore how this unification can transform clinical supply management from a reactive, manual process into a proactive, data-driven capability that reduces costs and risk and optimises clinical supply

Change is easy on paper, so how do you get your workforce to actually buy in and take the lead?

When organizational transformation stalls, the bottleneck is rarely strategy, it is the human element. Executing complex clinical change requires far more than top-down mandates; it demands genuine frontline buy-in. Drawing directly on time-tested leadership lessons from the military, this inspiring keynote reveals how to overcome change fatigue, align high-level vision, and empower your workforce to move from passive compliance to proactive leadership. Walk away with actionable, battle-tested strategies to build a culture of unshakeable trust, operational momentum, and shared ownership across your organization.