What GoR3 can offer?
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 and Transform the E2B R2 files to E2B R3 XML files as per the ICH defined rules.
GoR3 provide user’s ability to not only transform files from R2 to R3 but also allow business users to verify the transformed R3 files before transmitted to the Agencies and Partners so as to meet 100% compliance. GoR3 Provides users to compare multiple ICSR files in both R2 and R3 format in split tree screen view that can be drill down to lower nodes to compare specific message or specific block of th ICSR. Multiple files can be transmitted in single click by the reporting officer.
GoR3 will provide user to auto transmission/ auto import feature also to any particular reporting destination based on the configuration setting.
GoR3 provide dashboard indicator for outbound and inbound ICSR’s including the MDN status so the business users can track the movement of the R3 files and get an confirmation of the delivery of the files to Health Authorities and License Partners and vice versa. The utility hence able to handle the three ACKs received from agency – MDN, ACK2, and ACK3. Below is the description for the different types of ACK:
|ACK2||Acknowledgment when the file is moved from agency database to internal processing database e.g. when VAERS R3 moves to FAERS database an ACK2 is sent back|
|ACK3||Business Level Acknowledgment. When the transmitted R3 file is accepted in the agency database|
GoR3 has robust error log mechanism to track for any validation, parsing or transformation error and make business users alert for any error/warning during GoR3 validation and transformation.
GoR3 is capable of handling Error log to track about any validation, parsing or transformation error for outgoing and incoming files.
GoR3 also provide reconciliation report to verify whether all transmitted E2B + (R2) files for export were transformed and made available in outgoing folder as E2B (R3) file for export
Validation Business Rules:
We allow existing schemas provided by HL7 for ICH ICSR messages and ICSR Acknowledgement messages to be customized as per the business requirement. We parse the E2B R2 files based on the validation rules to make sure transformed R3 files has correct values for the DTD elements.
E2B Extension Elements:
To meet the local Drug Safety Units, We help customers to add new User Define Fields , map to extension DTD element of the profiles and customize the export logic for those newly added element and map them to the E2B R3 File. Example for below fields:
- Event medically confirmed
- Event Country
- Drug Characterization
- Event Seriousness
GoR3 can be customized to add the validation rule for these new User Define Fields.
GoR3 support Batch Report Transformation and Batch Report R3 transmission and Vice Versa.
GoR3 provide a coded/ decoded view of both E2B+ (R2) and E2B (R3) formats displaying E2B tags in line with the associated Argus Case form fields.
GoR3 can help you with updating the SOPs and work manuals based on E2B (R3) changes.
GoR3 can conduct the training of the staff in regards to the new changes and give possible approaches to deal with the problems with the implementation
GoR3 offers complete range of Pharmacovigilance and Device Vigilance Safety services
GoR3 offer the users site security to make sure E2B R3 files available on the dashboard to group of users per their site security.