Track 2: Clinical Trial Operations and Innovation
This track examines how clinical trials are actually executed and what it takes to enable change. Clinical operations is being rebuilt in real time: operating models are reorganizing around digital capability, AI is being asked to prove measurable impact rather than promise it, sponsors are rebalancing what they run in-house, and sites and participants continue to absorb burden the industry has not yet solved. Sessions bring together sponsors, sites, regulators, CROs, and patients across regions to confront these problems with evidence, metrics, candid accounts of what failed alongside what worked, and practical approaches to cost, complexity, enrollment, and data. Attendees will leave with frameworks, benchmarks, and applied approaches they can put to work immediately within their own organizations.
Themes
- Innovative Approaches to Accelerating Clinical Development: Faster, leaner, and smarter approaches to bringing new treatments to patients
- New Digital Operating Models in Clinical Development: AI, automation, and digital technologies transforming clinical trial execution
- AI in Trial Execution – Is It Working?: Real-world applications, lessons learned, governance, and measurable impact
- Clinical Operations Workforce and Talent: Building future-ready teams through leadership, workforce development, and change management
- Protocol Design, Complexity, and Feasibility: Designing operationally feasible studies that balance scientific and executional considerations
- Site Selection and Trial-to-Site Matching: Optimizing site identification, activation, performance, and strategic partnerships
- Sponsor, Site, and CRO Collaboration: Strengthening partnerships, governance, and collaboration to improve trial delivery
- Patient Partnership, Recruitment, and Retention: Integrating patient perspectives to improve study design, enrollment, and retention
- Study Start-Up, Vendor Selection and Trial Delivery: Streamlining feasibility, vendor selection, activation, and operational readiness to accelerate study execution
- Clinical Data Foundations and Infrastructure – Build vs. Buy: Evaluating data platforms, integration strategies, and technology infrastructure
- Operational Excellence, Oversight, and Risk Management: Applying quality, governance, vendor oversight, and risk-based approaches to trial execution
- Clinical Trial Costs, Productivity, and Technology Investment: Optimizing efficiency, technology investments, and operational performance
- Global Clinical Development Strategy and Policy: Navigating multi-regional trials, evolving regulatory landscapes, and global operational challenges.
Key Questions to be Addressed
- How can organizations accelerate clinical development while maintaining quality, compliance, operational excellence, and patient safety?
- How are AI, automation, digital technologies, and new operating models transforming clinical trial execution, and where are they delivering measurable value?
- How can sponsors, CROs, sites, vendors, and patients collaborate more effectively to improve protocol design, study start-up, recruitment, retention, and trial delivery?
- What innovative strategies are improving workforce capabilities, site selection, operational performance, and technology investments to deliver more efficient clinical trials?
- How are evolving global policies, regulatory expectations, and geopolitical changes shaping multi-regional clinical development and the future of clinical operations?
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DIA Direct: Clinical Trials Regulation (EU) 536/2014: A Missed Opportunity? Assessing the Impact on EU Competitiveness in Global R&D Clinical Trials
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A Guide to ICH Guidelines in Clinical Trials On-Demand
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DIA Direct: Using Artificial Intelligence in Clinical Trials - On-Demand
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Medical Devices and Drug-Device Combination Products Workshop: Post-Market Surveillance and Clinical Evidence
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Moving Forward with Decentralized Clinical Trials (DCTs)
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Pre-Marketing Clinical Trial Safety
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