Archives: Agenda

• Increasingly pharmaceutical companies are committing to reducing their carbon footprints in the execution of clinical trials.
• A more efficient and effective clinical trial supply chain can be created by implementing new clinical supply technologies and sustainable processes.

• Definition of the Intended Use case is a critical prerequisite for the DHT regulatory assessment
• DHTs should be fit for purpose -The required level of prior testing is greater for a primary/secondary endpoint compared to an exploratory endpoint
• Risk mitigation of clinical, cybersecurity and privacy risks are required to ensure patient safety
• Effective collaboration between the DHT Developer and Pharma Trial Sponsor is critical to ensure project success

• What is the long-term durability with gene therapy?
• Lessons learnt from the DMD case – what’s being done for patient safety?
• How are we educating sites, doctors and patients to provide the whole ecosystem with improved understanding of gene therapy?
• Hear about BioMarin case studies focusing on real-world data
• Choosing the right CRO for successful gene therapy product development

• Grabbing the attention of CROs/key vendors from a small and mid-sized company perspective
• Establishing criteria to select the best provider(s)/model to match your organization’s needs
• Effectively managing the ecosystem of multiple vendors: balancing risk vs. ease of control, and driving assurance of delivery
• What do sponsors need to know (and do) about vendor oversight
• As biotech/emerging pharma’s needs evolve, so should the model: how to keep up?

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources. This presentation will showcase:

• How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
• AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
• Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
• Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management