Track 2: Clinical Trials and Operations
This comprehensive track covers the latest advances in clinical research development and operations. Sessions cover innovative design strategies, establishing efficiencies in operations, and effective integration of patient outcomes in clinical trial design. Sessions explore: .
This track covers clinical research development and operations. Sessions explore:
- Current and innovative methods to evaluate technology advances and systems to support clinical research programs, cross-functional management integration, clinical utility, and endpoint development with the use of mobile/digital technology
- Optimizing clinical trial enrollment and reviewing technological advances in clinical research operations
- Optimal clinical operations management structures in small, medium, and large companies
- Program challenges and solutions in global clinical and multi-regional clinical trials
- Advances in Sponsor and CRO collaborations; vendor oversight; and the evolving value of real-world data
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.
Included Topic Areas
Unique challenges on clinical study execution for innovative drugs e.g., personalized medicine, gene editing, stem cells, regenerative therapies, gene therapies, etc.; clinical trial recruitment and retention; patient engagement, site management; specific therapeutic areas; endpoints/ COAs, [patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures; COA (Clinical Outcome Assessments) Compendium]; specific therapeutic areas; telemedicine, eHealth, mobile health, wearables, EHR (Electronic Health Record), clinical trial diversity, collaborations; ICH(E); GCP (Good Clinical Practice), audit/inspection, global study execution, and management.
Priority Topics
- Design and Operational Considerations for Research Involving “Schedule 1” Substances - Psychedelics, Cannabis, etc.
- Operationalization of Study Design
- The Future of Clinical Research Sites
- Best Practices for Forward-Thinking Clinical Project Management
- Vendor Implementation and Management
- AI and Generative AI as Your Co-Pilot
- Considerations Before Start-Up: Challenges and successes
- Diversity and Inclusivity in Clinical Trials
- Innovative Study Designs for Modern Clinical Trials
- Effective Use Cases of Site Burden Reduction