23 November 2018

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!