Archives: Agenda

• Full regulatory compliance supported by robust documentation and end‑to‑end traceability
• Complete transparency with no hidden or unexpected costs or fees
• Streamlined management designed to avoid any additional workload for study teams

Harnessing the convergence of high-fidelity data with advanced AI is now essential for de-risking clinical trials and accelerating therapies to patients. What if the distance between a draft protocol and a validated study execution plan was reduced to a single, unified simulation?

Join Medidata’s Rob Buka for a deep dive into the future of holistic trial design and planning. Learn how advanced modeling and simulation capabilities within a central workspace can revolutionize trial operations. This session will illustrate Medidata’s strategy for optimizing protocol design, predicting trial outcomes, and achieving greater clinical and operational success in the next generation of drug development.

For emerging biotechs and biopharmas, the path from early-phase trials to global development is filled with operational and strategic risk. Increasing protocol complexity, fragmented vendor landscapes, and varying regulatory expectations add layers of uncertainty. In this talk, Adam Marsh will outline key inflection points where risk can be proactively mitigated, from study design through execution and scale-up. Attendees will leave with a clearer framework for reducing execution risk while enabling faster, more confident decision-making.

Concept

Participants work through a real inspection finding scenario using an interactive training approach that combines regulatory requirements, audit observations, and AI-supported decision-making.

Takeaway: Transferable methodology for training teams to prepare for inspections using AI while maintaining audit trail and regulatory compliance.

Artificial intelligence (AI) is transforming R&D procurement from a transactional function into a strategic, data-driven discipline across all industries. As the backbone of clinical business operations, vendor management processes are equally impacted, including onboarding, qualification, risk tracking, and governance. This session will explore how AI-enabled solutions are set to redefine traditional Excel-based workflows, promising efficiency, scalability, and strategic decision-making.

This session will explore:

• How AI transforms R&D procurement from transactional to strategic.
• New trends: Excel-based workflows are being replaced by intelligent automation.
• Vendor onboarding, risk, and governance become data-driven and scalable.
• Procurement shifts from cost control to value creation.

• Addressing logistical challenges in clinical trials for blood sample processing
• Implementing solutions to stabilize biomarkers at collection and simplify workflows

Paediatric trials bring amplified risks, tighter regulations, and higher stakes for patient safety – but the lessons learned extend far beyond children’s studies. In this case study, we examine the unique challenges of conducting a paediatric clinical trial and explore how its insights can be applied to improve planning, safety oversight, and operational efficiency in any therapeutic area.

• Navigating Complex Risk Profiles: Managing safety, dosing, and ethical considerations in vulnerable populations.
• Pharmacovigilance in Practice: Meeting rigorous monitoring and reporting demands under high scrutiny.
• Recruitment and Engagement Strategies: Overcoming barriers to participation with patients, caregivers, and advocacy groups.
• Transferable Takeaways: Applying lessons from paediatric research to accelerate and safeguard trials in all therapeutic areas.