DBA Systems, Inc is an established drug safety software consulting company in the industry with six years of continuous innovation and support.
GOR3 is a solution to handle the new ICH E2B R3 regulations to meet the compliance requirements for FDA and EMA to transmit E2B R3 reports including E-VAERS and E-MDR. GOR3 can be easily plugged into your existing Adverse Event Reporting System to validate and Transform E2B R2 files to E2B R3 XML filesas per the ICH defined Validation rules.
MedUM tool is to help Pharmaceutical, Bio-techs and CROs to manage and streamlineMedDRA coding and upgrade. This software can be customized and plugged into any Safety System.
DBA Systems, Inc.
ICH E2B R3 Details
The International Conference on Harmonization (ICH) has released step 4 guidance for a E2B (R3) format for electronic exchange of Individual Case Summary Reports (ICSR). The new format is based on Health Level 7 Version 3...
DBA Systems ICH R3 Offerings
With new ICH E2R Requirement around the corner,there is a need for either short term or long term solutions to meet this new challenge. Immediate solution is to upgrade your adverse...
Our Consultants have worked with the below customers during Support,Implementation, Migration,Customization engagement with below clients