- Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
- How do strategic alliances impact this decision?
- How to best interact with CDM vendors
- Understanding CDM outsourcing strategies for small to big pharma with differing resources
Archives: Agenda
Morning refreshments and networking
KEYNOTE: Leveraging Machine Learning and Security Orchestration, Automation, and Response (SOAR) to combat cyber threats in clinical data operations
- 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
From automation to autonomy: How Agentic AI is transforming clinical data management
- 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.
Why patient-centric data management matters and how can we prioritize this focus?
- 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?
Chairperson’s opening remarks
Registration and refreshments
Challenges in clinical data management in oncology trials
- 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
Afternoon break, networking and prize draw
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!
PANEL DISCUSSION: Navigating the noise: Practical ways AI and ML are accelerating clinical data management
- 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