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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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Monday, June 24

Tuesday, June 25

Wednesday, June 26

Take a sneak peak into one of our video interviews from DIA 2018 with Dr. Robert Nelson, Senior Director, Pediatric Product Development, Johnson & Johnson, and previously served as Deputy Director and Senior Pediatric Ethicist in the FDA Office of Pediatric Therapeutics. He discusses the regulatory and ethical considerations with placebo administration using a central venous access device in a pediatric trial.

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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