Built upon CT Renaissance™ as a part of CT Renaissance™ suite, and also available as an individual software solution is eSUBMIT™ - a web based electronic data submission platform, which was developed in conjunction with the FDA. This eCTD system integrates data from clinical trials into a CDISC compliant data repository and performs automated workflows of screening for safety issues. This renaissance tool provides an effective means for electronic submissions to the FDA in the eCTD format and also in labeling of the drug.
eSUBMIT™ performs the following tasks with ease and perfection
Site Specifications
