Archives: Agenda

• It’s no longer a question whether digital transformation will happen—it is how fast we can scale it.
• When innovations such as eSource/EHR-to-EDC operate at full swing, it will allow us to perform research that otherwise wouldn’t happen and to develop medicines that otherwise would never make it to the patient
• Scaling up the technology opens new avenues for collaboration, involving pharmaceutical companies, hospitals, along with technology vendors and academic partners.

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

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)

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.

• Overview of outsourcing models: Full-Service Outsourcing (FSO), Functional Service Provider (FSP), and in-house
• Pros and cons of each model and how to select the best fit for your trial
• When hybrid approaches (mixing outsourcing and in-house) are more effective than fully outsourcing or keeping trials fully internal
• Understanding why FSP is gaining popularity among sponsors and how it can help meet trial timelines