News

23 November 2018 News

Double Strike

Industry news - not one, but two big updates for the study data submissions:

  • FDA Validator rules 1.3, issued last week
  • SDTMIG v3.3, release date 20-Nov-2018

Study data submission process has gained a tremendous amount of changes during the years, starting from the development of SDTM  standard up to its being a regulatory requirement for the FDA and PMDA data submissions.

MainEDC is evolving together with regulatory requirements for data submissions!

The automatization of all data submission processes is the primary focus now. MainEDC v4 is a solid basis for this kind of changes and is ready for the next step!