According to Health Authority regulations, Pharma companies must submit their AE (Adverse Event) data to Local Health Authorities in the countries where they sell the medicine. This poses an immense challenge, as most local health authorities require translating certain data elements into local languages for domestic serious and non-serious case submissions before reports can be generated for submission in the Argus safety system.
The source of the challenge can be traced to the current reporting process followed by pharma companies.
– Scenario 1: As per the current reporting process, AE cases that do not require Japan reporting are locked and submitted directly to the Global Health Authorities. For submission to domestic health authorities, the report is unlocked to add the local translation and then locked again before transmitting it to them.
– Scenario 2: If a locked case receives significant follow-ups, it is unlocked for further processing. In such a case, the domestic case processors do not get an opportunity to add the local translation for report submission.
– Scenario 3: For AE cases that require Japan reporting, they are locked and moved into the Japan workflow. The local case processors can only access these cases after a Japan lock has been added. They can then unlock the case, add the local translation, and submit it to the domestic health authorities, resulting in significant delays.
How it works
Ultragenic’s proprietary solution, UltraREG, provides a complete solution for the above-stated challenges in local data entry and reporting.
UltraREG has two basic components aligned with the customer’s business process for local data entry.
1. Safety System Automations:
- Auto generate Action Item in case a report qualifying for local data entry is auto/manual scheduled after Case Global Lock (Mandatory).
- Hard Validation to prevent manual closure of the Action Item for Local Translation, and to prevent case Unlock if the Action Item is open (Mandatory).
- Auto population of case fields based on local Dictionary (Korea, China, C3 etc.) depending on the in-scope requirements (Optional).
2. Custom Web Interface Developed on Oracle APEX:
- Direct Login to Interface from Safety System for authorized users via passing an authentication token.
- Separate Landing page for users from different Country Organizations, allowing workflow managers to prioritize cases for further processing.
- Two-step workflows for each case (Data Entry as per regulation, Quality Review by a peer) before it can be marked as complete in APEX. These changes are audit-logged in the APEX Interface.
- Local Data is back-populated in respective Safety System fields, and the Health Authority Report is regenerated and distributed automatically. The Action Item for Local Translation is closed, and the case becomes available for Unlock. All these changes are audit-logged in the safety system.
With the help of UltraREG, all the scenarios outlined in the challenges section can be resolved easily. The process of back-populating translation, closing Action Item in the Safety System, and transmitting the report to local health authorities is fully automated.
- Support for JeMDR, Korea R3, NMPA R3, etc.
- Local Data Entry in regional languages, supporting all languages.
- Complete Form Translation.
- Configuration capabilities to add or modify forms as required.
- Easily deployable and lightweight solution.
- Generates regional reports (both paper and E2Bs).
- Seamless Integration with the safety system.
- Option to inherit user & groups.
- Site, Product, and Study Security.
- Sync with the safety system config.
- Regular submission workflow.