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Track 2: Clinical Trials and Clinical Operations

DIA 2017: Driving Insights to Action

This track covers clinical research development and operations. Sessions explore current and innovative methods to:

  • Evaluate technology advances/systems to support clinical research programs and integrate cross-functional management
  • Optimize clinical trial enrollment and novel techniques for subject retention
  • Evaluate the clinical utility and endpoint development with the use of mobile/ digital technology
  • Identify clinical questions and gaps resulting in barriers to efficient clinical research development/management
  • Review optimal Clinical Operations management structures in small, medium, and large companies
  • Apply innovative protocol techniques, designs, and technology to accelerate decision-making/development
  • Review technological advances in clinical research operations including site management, patient enrollment, and project management tools
  • Review advances in patient centricity in relation to protocol optimization (quality-by-design), the use of technology and PRO
  • Review currently accepted endpoints in selected therapeutic areas and validation considerations for potential future endpoints
  • Program challenges and solutions in global clinical and multi-regional clinical trials
  • Program management advances in Sponsor/CRO collaborations and vendor oversight
  • Discuss the evolving value of real-world data including study designs, operational considerations

Sessions in Clinical Trials and Clinical Operations

Sunday, June 23 | Short Courses

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Included Topic Areas in Clinical Trials and Clinical Operations

DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.

  • Utilization of mobile/digital technology in clinical trials
  • Patient centricity in study design, particularly with rare disease considerations and best practices for obtaining and incorporating subject and advocacy group input in protocol design
  • Application of patient input and advocacy groups in enrollment and retention
  • Best practices for balancing patient input with sponsor decision-making (i.e., protocol feasibility issues)
  • Technological methods and approaches to increase clinical trial management and operational efficiencies
  • New collaborations tools for sponsors and CROs to improve clinical trial operational efficiency
  • Latest innovation for managing investigational product and global clinical supply
  • Clinical operation considerations in trials with adaptive designs
  • Optimal management and staff organization and resource deployment for clinical operations departments in biopharmaceutical companies of various sizes
  • Considerations and latest developments for common protocol templates

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.

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