As marketing authorization holders (MAHs) strive to meet the EMA requirement of downloading E2B (R3) files from the EVWEB portal, PvD’code EV Triage is the cloud-based software tool that automates the triage process of segregating and reconciling applicable cases from other non-relevant cases.
Problems faced till date
- Challenge of downloading R3 files from EVWEB
- Difficulties of reviewing R3 file as it is not a readable format
- Much human effort to be put on for identifying applicable/valid/MAH cases as PV processing teams had to spend many manual hours reviewing and determining which downloaded cases have any relevance to company products
- Problems faced for keeping track of non-relevant/invalid cases
- Tracking of invalid/Non-MAH case, with relevant reason for future analysis
Solution
- Our tool PvD’code, automates the process of triaging case activities
- It auto reads the EV XMLs and coverts it in readable format (PDF)
- By using Predefined algorithm case is automatically marked as MAH/valid case and non MAH/invalid case
- The given algorithm can be modified as per client’s SOP
- Then all the valid ICSR are sent out for further processing in our case processing module of PvEdge
- PvD’code EV Triage can be used with any PV system or E2B converter and leverages an intuitive user interface to significantly reduce the manual effort required to separate the cases relevant to the MAH
Key Benefits
- Significantly reduces the manual efforts required to separate the cases relevant to the MAH and for duplicate checks
- Offers full interoperability with any PV system or E2B converter of choice
- Tracking of invalid and duplicate cases for future analysis and review
- Speeds case reconciliation
- Maximizes efficiencies of a pharmacovigilance (PV) team to focus on more critical tasks
- Efficient checking system
- Auto checking conditions can be modified as per client’s SOP
- Deploys quickly as a cloud-based plug-in as well as on-premise