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Clinical Trials and Data Science Conference

Break Out Sessions 2B: Data Quality, Governance and Sharing – Enabling Insights and Decision Making

Session Chair(s)

Patrick Brady, PharmD

Patrick Brady, PharmD

  • Head Regulatory Policy & Intelligence
  • Bayer AG / Research & Development, Pharmaceuticals, Germany

Advancements in technology and the amount of data generated from an increasing number of data sources has led to the proliferation of data brings into the question the capacity to manage the volume, velocity, variety, veracity, and value of data (The 5 V’s of Big Data).  Although these advancements have present new challenges for data management and, more specifically, clinical data management, it also presents new opportunities in the form of digital health solutions that support more robust clinical research data through decentralized clinical trials, Real World Data/Evidence, Complex Innovative Design Trials, introduction of wearables and mobile software applications for improved clinical decision and patient decision support

Speaker(s)

Jesper Kjær, MS

Jesper Kjær, MS

  • Co-Chair, EMA/HMA Big Data Steering Group; Director of Data Analytics Centre
  • Danish Medicines Agency (DKMA), Denmark
Fiona Maini, MS

Fiona Maini, MS

  • Principal Global Compliance and Strategy Principal
  • Medidata a Dassault Systèmes Company, United Kingdom
Vada A. Perkins, DrSc, MSc

Vada A. Perkins, DrSc, MSc

  • Executive Director, Regulatory Policy and Innovation
  • Bayer AG, United States

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