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David A. Evans
Partner, LookLeftGroup

Brief Bio

Mr. Evans is a senior technology and clinical research executive with over twenty years experience in the clinical research, regulatory and healthcare industries. He has served as Chief Technology Officer and Sr. VP Clinical Data Management for a leading clinical research organization and as Chief Operating Officer for a clinical software development firm. He has extraordinary experience in clinical data management, clinical trial management, complex clinical data warehousing, regulatory data analysis, automated data capture and clinical business process engineering.

Mr. Evans is recognized industry-wide as a leading technology visionary for developing and implementing complex process and system solutions. In addition, he has extensive business and corporate development experience in positioning products and services in the pharmaceutical/healthcare marketplace. Mr. Evans is a frequent speaker at national professional meetings and has led numerous industry committees and conferences.

Major Accomplishments

  • Architect and Designer of Clinical Data and Trial Management systems for Major Pharmaceutical Companies using XML and CDISC standards.
  • Complex clinical data warehouse architect for numerous NDA submissions.
  • Conceived the Computer-Assisted New Drug Applications (CANDA) concept.
  • Designed, developed and implemented first CANDA system submitted to the FDA in 1985.
  • Responsible for the submission of over 65 CANDA/eSubmissions systems over the past 15 years.
  • Worked interactively with over 100 FDA Review Officers on supporting over 70 New Drug Applications.
  • Designed, developed and implemented the CANDA Navigator® in conjunction with the FDA and pharmaceutical industry to automate analysis and review clinical information.
  • Designed, developed and implemented in 1984, the first Remote Data Capture (RDC) system used by the FDA for safety review.
  • Led the design, development and implementation of numerous diagnostic clinical information systems including 24-hour ambulatory EKG Holter analysis, ambulatory blood-pressure analysis, trans- telephonic EKG analysis and clinical blood laboratory analysis.

 

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