Archives: Agenda

Regulatory bodies are promoting Risk Based (Quality) Monitoring as a best practice in clinical trials to correct data quality issues as early as possible in the trial lifecycle.  Since this involves the identification of specific patterns in large datasets, artificial intelligence can support us in doing this efficiently.

• How can AI find specific patterns that humans might miss
• Interactions between AI and humans in RB(Q)M
• Real life examples in respiratory

How to:

• Harness regulatory dynamics for strategic advantages.
• Obtain feasibility figures true to delivery.
• Employ innovative study designs to expedite the development program.
• Customize efficient patient recruitment tactics!

• Strategies for sourcing components from a scattered ecosystem
• How to develop meaningful, human-centric measures
• Pitfalls and opportunities for analytical and clinical validation
• Novel solutions and digital pathways for scalable regulatory qualification
• Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

• Increasing patient engagement and involvement
• Improving diversity in clinical trials
• Considering sites and patient safety

• Considering recent key geopolitical trends’ impact on the future of healthcare and pharma
• Investigating the cause of recurring supply chain disruptions
• Learning how to build supply chain resilience

• Orphan drug market: Illustrate the unique challenges of developing a drug for rare diseases
• Patient-focused drug development: Designing patient-centered clinical trials
• Operational considerations: Endpoint selection; reducing the burden of participation; cost; sites; patient concierge services
• Collaboration: Focus on the need for collaboration in this space: sponsors, CROs, patients, patient advocacy groups, investigators, vendors

• Clinical trial outsourcing strategies
• Sponsor company expectations and CRO selection
• Clinical trial oversight – considerations for finding the right balance between efficiency and safety

• Why it is so important to have proper oversight over study conduct
• How to make it smooth and effective
• Which aspects of the trial should have your special attention
• How CRO can support with keeping oversight on the proper level