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Track 2: Clinical Trials and Clinical Operations

This comprehensive track covers the latest advances in clinical research and operations. Sessions cover innovative design strategies, establishing efficiencies in operations, and effective integration of patient outcomes in clinical trial design.

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.
  • Topics Related to Clinical Trials with Modern Study Designs Including Adaptive Studies, Platform Studies, Master Protocols, Pragmatic Studies, Use of External Controls, and Use of RWE/RWD to Inform Study Design and Drug Development Programs
  • The Clinical Site of 2024 and Beyond- What is the Present and Future State of Clinical Research Sites in Workforce and Training, Contracting and Budget Considerations, Infrastructure, Organization, and Oversight
  • Best Practices for Forward-Thinking Clinical Project Management - the Management of International Research Studies, Incorporation of Diversity Considerations, Making Data-Driven Decisions on Site Selection, and Participant Recruitment Planning
  • Endpoint Sciences- PRO/ePRO, Surrogate Endpoints and Validation, the Appropriate Use of Digital Biomarkers
  • Informed Consent and Communicating with Study Participants- How do we Communicate Increasingly Complex Study Information in a Respectful, Informative, and Innovative Way?
  • Artificial Intelligence (Generative AI) and its Role and Future Uses in Clinical Trial Operations

Registration Rates

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