DBA Systems has also designed and developed MedDRA Upgrade and Management© tool to help Pharmaceutical, Bio-techs and CROs to manage and streamline MedDRA coding and upgrade. This software can be customized and plugged into any Safety System. This tool provides user...

GoR3 is a solution to handle the new ICH E2B R3 regulation to meet the compliance requirements for FDA, PMDA 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...

GoCARS(Capture Adverse Reaction System) is a web-based intelligent, intuitive adverse event data capture solution that help Life sciences organizations to capture, quality review and then submit the cases to the Safety Database of the organization via E2B R2 and E2B R3.

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...

GOR3 is a solution to handle the new ICH E2B R3 regulation to meet the compliance requirements for FDA , PMDA and EMA to validate,transform and transmit ICH E2B R3 to EMA, E-VAERS to FDA-CBER and E-MDR to FDA-CDRH.

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...