Identifying where fragmented data slows decision making
Connecting EDC eCOA and external data sources
Defining clear roles to avoid duplication and gaps
Improving data review to reduce manual effort
Integrating systems without adding complexity
Sharing practical examples of what has worked (and what hasn’t)
Highlighting key challenges and how to overcome them
Comparing tools in terms of ease of implementation, cost, and impact for smaller teams
Exploring which solutions are realistically adoptable within limited resources and existing systems
Exploring why protocol amendments, slow enrolment and late feasibility surprises are often failures of execution rather than science
Applying real-world operational evidence to trial design decisions before problems surface
Identifying execution risks early to design more predictable, scalable trials
Including a live demonstration of Aika, Biorce’s AI-driven clinical trials assistant
What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
Why current consent and audit-trail architectures will not survive a participant’s right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries
Understanding why delays still happen despite forecasting planning and risk mitigation strategies
Identifying gaps in real-time data visibility and decision-making across supply teams
Improving communication between sponsors vendors and sites to enable faster response
Building processes that allow supply to adapt quickly to changing trial conditions
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