Archives: Agenda

Strategic Site Selection: Identifying the Right Sites, People, and Advocates for Trial Success

Selecting the right sites and investigators is critical for successful clinical trials, especially in multidisciplinary studies. This session will explore strategies for targeting sites that align with study goals, investing in investigators who not only have the skills but also believe in the product, and leveraging key opinion leaders (KOLs) who can enhance the trial’s impact. We’ll cover key factors in recruitment, including site capability, investigator influence, and alignment with product objectives.

  • Learn strategies for identifying and selecting sites that align with trial needs and patient demographics.
  • Understand the importance of choosing investigators who are both competent and product advocates.
  • Explore the role of KOLs in influencing trial outcomes and enhancing product credibility.
  • • Discover best practices for collaborating with the study startup team to ensure smooth trial initiation.

Cybersecurity in Vendor Qualification

This session will highlight the importance of cybersecurity in vendor qualification, discussing current challenges, and provide practical strategies to safeguard clinical trial data and processes.

Interactive Workshop: Navigating the Maze: Regulatory Submissions in Clinical Trials

 

  • Building a Global Regulatory Strategy: Insights, Pitfalls, and Lessons Learned
  • Setting the Standard: Best Practices for Successful Regulatory Submissions
  • Fast-Tracking Innovation: Accelerating Regulatory Pathways in Special Contexts
  • Understanding Delays: Challenges in the Evaluation of High-Risk Clinical Trials
  • Patient-Centric Strategy in Regulatory Submissions: The Role of Sponsors and Regulators

AI in trial master file management: The good, the bad, and real-world use cases.

·       Use Cases: How AI has already improved efficiency and compliance in TMF operations with numbers and KPIs we all love

·       The Pitfalls and Limitations: Where AI still falls short

·       Human + AI = Better TMF: Why the most effective setups are hybrid — combining AI speed with human oversight

·       What’s Next? A look into emerging trends and how sponsors and CROs can start preparing for AI-enabled TMF strategies

 

Rethinking Clinical Operations: A Smarter, Faster Playbook for Trial Success

The CRO-Sponsor model is broken. This session will explore a fresh approach to clinical trial outsourcing, addressing inefficiencies in the traditional CRO-Sponsor model. Learn how to enhance collaboration, improve trial execution, and accelerate timelines with a results-driven framework.

 

•         Discover a smarter outsourcing model that boosts agility, transparency, and accountability.

•         Learn how the “High-Retention” Trial Strategy—powered by AI-driven recruitment and patient engagement—helps achieve enrolment targets faster.

•         Explore real-world case studies showcasing optimized trial execution across high-risk indications.

•         Gain insights into the biggest shifts shaping clinical operations over the next five years—and how to stay ahead

 

PANEL The Clinical Trial Landscape for Small to Mid-Sized Biopharma in Europe

  • New regulations and guidance around clinical trials in the EU: how will this impact you?
  • Staff turnover and layoffs: handling changes in the industry in order to ensure success
  • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
  • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?