Archives: Agenda

• A look at how the digital transformation of clinical trials has created unprecedented cybersecurity challenges in protecting sensitive patient data and maintaining trial integrity
• Examining how artificial intelligence and SOAR technologies are revolutionizing clinical data protection against sophisticated cyber threats, particularly Business Email Compromise (BEC) attacks
• Demonstrating how AI-driven security solutions, integrated with SOAR platforms, can detect and respond to threats in real-time while maintaining GxP compliance
• A practical framework for implementing AI-enhanced security measures in clinical data environments, including zero-trust architectures and automated response protocols for protecting electronic data capture systems.
• Gaining actionable insights into building robust cybersecurity frameworks that leverage AI capabilities to protect sensitive clinical data while ensuring regulatory compliance

• Explain how Agentic AI elevates clinical data management beyond rule-based automation.
• Understand the role of reasoning models in enabling autonomous decision-making within clinical trials.
• Identify key ways AI agents can improve data oversight, reduce operational burdens, and support regulatory compliance.
• Explore real-world considerations for deploying Agentic AI within existing clinical workflows.

• Demystifying individual participant data return to modernize and personalize clinical trials
• An end-to-end data-driven patient journey: from patient-friendly DCT conduct to individualized patient data return
• Use-cases: What measures will enable its adoption?
• What can we do to ensure the safe handling of vast amounts of sensitive patient data?

2:45pm – PRIZE DRAW
Visit our exhibitors’ booths throughout the 2 days and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple prizes or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall. Make sure you don’t miss out!

• How to create a patient-centric clinical protocol to obtain the necessary data and validate your primary objective
• Overcoming trial inefficiencies by better aligning HER systems at the site with EC systems CROs use
• You don’t know what you don’t know: tackling knowledge limitations to allow your drug trial to succeed

• Demystifying the language of AI to assess whether it’s really the right solution for your study
• Concrete use cases for its successful and unsuccessful implementation
• Addressing concerns of inherent bias in data and increased data security and privacy fears
• What systems and vendors are on the market, and assessing their offerings for your specific data needs

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within clinical data management. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Selecting the right strategic clinical data outsourcing model to meet changing clinical development needs

Roundtable 2
Sharing best practices for managing external data such as biomarkers and how sponsors are approaching this
Hosted by Tina Patel, Data Delivery Head-Early Development, Sanofi

Roundtable 3
Data identity, Integration, and privacy issues and opportunities to consider while enabling patient-centric data management
Hosted by Dinesh Pillaipakkamnatt, Former Director, Business Enablement Lead in Digital Innovation, Merck