Vision / Mission

OUR HISTORY

EDETEK was founded in 2009 by Jian Chen and incorporated in the state of New Jersey. The company was created for the purpose of building and marketing highly specialized software and corresponding services addressing the needs of Clinical R&D for the Pharmaceutical, Biotech and Medical Device industries. We are a US based organization headquartered in Princeton, NJ with additional offices in the US, Asia and Europe. The Headquarters office houses the corporate leadership team and key US-based personnel. EDETEK employs over 100 people globally

MISSION & VISION

EDETEK provides comprehensive business and technical solutions to advance the science of medicine and improve the quality of life of people around the world. We utilize our clinical platforms, Panther CTMP™ and CONFORM™, to fulfill our clients’ data engineering and business analytics needs. Our comprehensive metadata driven solutions, coupled with our extensive experience, knowledge and capabilities allow us to offer unparalleled advantages in data quality, time to completion, and cost efficiency.

KEY FACTS

  • ISO 9001-2008 Certified
  • Study Conduct, Data Management and Statistics for all Phases of Clinical Development
  • Experience in a wide variety of Therapeutic Indications
  • Support for IND’s, NDA’s, BLA’s, PMA’s, 510k’s
  • CDISC “Gold Member” and Registered Solution Provider (RSP)
  • Active member of Six CDISC Working Groups: SDS, ADaM, CDASH, ODM, CT, Share
  • Prepare Hundreds of SDTM, ADaM and TFL Study Packages, Study Statistics and Data Conversion for Legacy and Live Studies Annually
  • Completed 10 Statistical Submission Packages (including ISS/ISE) 2015-2016
  • AWS Life Sciences Partner