Archives: Agenda

• There is no “best model” – but there are wrong ones
• Sponsors owning systems ≠ control if operations sit with CROs
• CRO-owned systems ≠ efficiency if oversight is weak
• The real question is not ownership – it’s control of data, processes, and timelines
• System ownership decisions directly impact: inspection readiness, study startup speed
• Case study: SOLTI’s transition from legacy Oracle to modern SaaS
• What Solti would do differently today

Despite decades of experience implementing electronic clinical outcome assessments (eCOAs) in clinical trials, we continue to grapple with the same operational challenges during set-up and implementation. They’re solvable – yet they persist. Why?

This presentation will discuss key barriers that continue to slow progress, including:

• Licensing and copyright holder review processes
• Perceived need for screenshots for IRB/EC submission
• Fragmented stakeholder collaboration and lack of true partnership
• Unbalanced expectations – electronic vs paper, BYOD vs provisioned
• Missconceptions around regulatory expectations

By addressing these challenges head-on, and fostering genuine collaboration, we can solve them if we truly want to gain efficiencies and optimisations in clinical trial set-up.

This session explores the early protocol decisions that most strongly shape trial execution and the operational principles that matter most. Using real-world protocol scenarios as the anchor, it will examine how seemingly small design choices can create or prevent major downstream complexity

• How the same protocol can lead teams in very different operational directions
• Where small ambiguities become big execution problems
• Which protocol elements deserve the closest scrutiny before build begins
• How aligning design and operations early ensures readiness and reduces risk

• Europe has lost market share in global clinical, mainly to APAC
• Europe’s lasting strengths are in science and expertise
• Partnership and integration are key to success and CROs have a key role to play
• The EU is acting now to restore Europe’s competitiveness
• Europe’s long-term outlook may be stronger with the right changes

Gain insights from a Clinical Trials Global Regulatory Lead on navigating the evolving global regulatory landscape, from early development through to submission readiness.

• Anticipating regulatory expectations and aligning strategies early in development
• Integrating regulatory perspectives across Phase I–III to streamline approvals
• Common challenges and proactive approaches in global filing preparation

Why the oversight of CROs need an evolution

• Transforming Role of the CRO: from vendor to strategic allies
• Changing mindset from sponsor holds risks to sharing risk approach
• Implementing the change in various types of trials

The cards are already on the table. The question is whether Europe knows how to play them. This session explores how the EU can turn global uncertainty into a defining moment for clinical research, manufacturing and R&D leadership.

• Closing the gap with the USA and China: accelerating decision timelines, unlocking translational funding and giving NCA alignment real teeth across all 27 member states.
• Turning US instability into EU opportunity: how NIH cuts, FDA uncertainty and policy unpredictability are opening a window for EU-first trial strategies and how long it may stay open.
• Making regulatory alignment stick: from ICH harmonization to more effective collaboration building a system where alignment is enforced, not just encouraged.

This session will cover:

• What the data reveal about EU’s competitive position
• EU CTR: momentum gained, limitations encountered, and unintended consequences
• Beyond CTR: how IVDR and MDR are reshaping clinical research delivery
• What must change for EU to remain attractive, including initiatives shaping the future EU landscape (FAST‑EU, COMBINE, EU Biotech Act)