Track 2: Clinical Trials and Clinical Operations
This comprehensive track covers the latest advances in clinical research and operations. Sessions cover the latest innovations in collecting clinical data, establishing efficiencies in operations, and effective integration of patient outcomes in clinical trial design.
Sessions in Clinical Trials and Clinical Operations
Monday, June 15
- Clinical Trials in a Digital Age: A Modern Approach to an Outdated Model
- How Do You Oversee and Manage New Centralized/Remote/Site Monitoring Models? What Should You Measure to Gain Insights?
- The Rare Disease Clinical Outcome Assessment Consortium: Aiming to Fulfill Unmet Drug Development Endpoint Measurement Needs
Tuesday, June 16
- Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials
- If You Build it, Will They Come? What’s Really Needed to Transform Information Flow in Clinical Development
- Data Driven Monitoring Enabled Through Analytics and Quality Risk Management
- Non-Traditional Clinical Trials Require a Non-Traditional Workforce
- Practical Solutions for Designing and Conducting a Digital Health Trial
- Examining Diversity in Clinical Trials
- The Development of Novel Digital Endpoints
Wednesday, June 17
Thursday, June 18
- FDA Perspectives on Modernization of Clinical Trials: Real World Evidence, Decentralized Clinical Trials, and Digital Health Technologies
- Qualification and Oversight in Decentralized Trials: Practical Considerations for Clinical Operations and Quality Oversight
- How the FDA’s MyStudies Platform is Accelerating the Use of Digital Technology in Clinical Research and Clinical Trials
- Older People Can’t Use ePRO and Other Industry Myths: An Interactive Debate
- The Power of Real World Data and the Innovative Approaches for Usage
- Managing Global Clinical Trials in Emerging Regions: Latin America
- Optimizing Study Start Up Processes: Site Selection, Budgeting, and Contracting
- Faster, Better, Cheaper: The Changing Role of Real World Data in Drug Development
- Journey of TMF Reference Model in Driving Inspection Readiness: The Decade's Impact, the Evolution to Come
- Design and Implementation of Multiregional Clinical Trials (MRCT) Using ICH E17 Guidelines
- Pediatric Clinical Trial Design and Ethical Considerations: Understanding Prospect of Direct Benefit and Risk
- Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse
- Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)
- Artificial Intelligence: Use Cases from Real Trials
Who is This Track Designed For?
DIA recommends this track and associated sessions to professionals involved in: clinical operations, clinical research, safety and pharmacovigilance, project management, patient centricity, and statistics. Also, potentially: medical affairs, regulatory affairs, vendor management/alliance management, data management, and quality assurance.