Archives: Agenda

Interactive session with audience engagement.

Focusing on advancing women’s health and meeting unmet needs

• Patient-reported outcomes (PRO), are becoming more prevalent in trials, often collected by a phone App
• While PRO can increase subject engagement, these data are subjective and cannot support regulatory approval alone
• By understanding the relationships between objective and subjective data endpoints (cortisol level to stress, glucose to Oxygen levels to activity, etc.), trial designers can balance “hard” and “soft” data points.
• These can be collected, analyzed, and presented to regulatory bodies so that data streams support one another, increasing likelihood of regulatory approval for the product.

• Addressing the perceived and real life operational challenges of using sensors in clinical trials
• How to deliver better site and patient experiences with sensors
• Logistical considerations for those on the ground deploying sensors (including training for site staff and patients, as well as sensor storage and distribution)
• Strategies to reduce the friction of multi-vendor management

Under EU MDD, class III implants could often be approved for marketing with only post market clinical follow-up requirements. EU MDR has considerably raised the barrier to entry with more refined rules for equivalence and definitions for sufficient clinical evidence to support a medical device’s safety and performance assessment.

• Prior Go to Market Strategy under EU MDD
• Farewell CE Mark First Strategy
• First in Man strategy considerations
• Global Pivotal Trial Strategy

This presentation explores how AI technology and data standards can elevate the quality of medical imaging document generation and data management.

This presentation explores how:

• AI technology and data standards can elevate the quality of medical imaging document generation and data management.
• Generative AI can produce and verify standardized study documents using a structured questionnaire and quality checks.
• With expert oversight, Clario is automating the CDM process by mapping, cleaning, reviewing, and exporting medical imaging data through SDTM standards and quality control mechanisms.
• AI technology can improve workflow and data cleaning processes, detect errors, and ensure high data quality.
• Technological advancements can offer real-time analytics and insights for the quality of medical imaging data.

• How real-world data can inform clinical trial planning
• Highlights of regulatory guidelines for the use of real-world data in clinical development
• How can real-world data add value in the clinical development process
• Case Study

• Identify and assess the possibilities for AI in your clinical trial
• Understanding the technologies behind AI such as machine learning, deep learning, neural networks, and algorithms
• Social and ethical implications of Artificial Intelligence
•  A contextual understanding of AI, its history, and evolution, helping you to make relevant predictions for its future trajectory.
• Looking at how to successfully implement AI into your clinical trial
• Case Study Overview