By Dr C David Hardison, Board of Directors of CDISC and Vice President, Life Sciences, of First Consulting Group, Dave Iberson-Hurst, Founder of Assero Limited, and Dr Rebecca D Kush, President of CDISC
Dr C David Hardison is Vice President of the FCG Leadership Council. He is responsible for the global development of business and information management services, transforming the commercialisation capabilities of pharmaceutical, biotech and life sciences companies. He currently serves on the Board of Directors of CDISC and the University of North Carolina Board of Visitors. David has a PhD in Biostatistics from the School of Public Health at the University of North Carolina, and a BSc with High Honours in Mathematics and Computer Science from Vanderbilt University.
David Iberson-Hurst is the founder of Assero Limited. After graduating in Mathematics and Computing from Bath University in 1982, Dave gained experience working on high reliability, real-time and information technology systems. Moving into the pharmaceutical industry, Dave spent three years as Chief Technology Officer for a start-up company, before founding Assero Limited - focused on the use of CDISC data interchange standards. Dave is a member of the European CDISC Coordinating Committee and was recently invited to join the CDISC Technical Coordinating Committee.
Dr Rebecca Daniels Kush is a founding member and current President of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit organisation dedicated to the development of global data interchange standards for clinical trial data. She is also a Co-chair of the DIA eClinical SIAC, and is currently a Director on the Board of the DIA. Prior to this, Rebecca founded consulting company Catalysis, Inc and was the lead author of the book, eClinical Trials: Planning and Implementation. She holds a PhD in Physiology and Pharmacology from the University of California, School of Medicine. The Clinical Standards Data Interchange Consortium (CDISC) has, at the start of 2004, reached a significant point in its mission of developing standards for the interchange of clinical trial data. Since its inception, the consortium has focused on the development of four models for use in the capture, exchange, submission and archive of electronic data to support product development in the biopharmaceutical industry (see Figure 1).
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