Archives: Agenda

• Rising scientific and operational complexity is reshaping global biotech
• Biotech confidence is strong despite escalating funding and R&D pressures
• AI and modern trial designs are accelerating development and decision making
• Operational discipline, especially protocol quality, now drives timeline performance
• Integrated CRO partnerships enhance predictability across the development lifecycle

Building out the RFI? What you outsource, what you need, and how many site visits? AI

• Extracting and standardizing key details from unstructured vendor documents
• Identifying inconsistencies, omissions, or gaps within proposals
• Supporting decision-making while safeguarding confidentiality and protecting intellectual property contained in submissions
• Case Study

Moderator: Silvana Giro, Senior Management, Global Medical & Regulatory Affairs, Bracco Imaging

• 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

• 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.

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

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

• 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