Faced with a tremendous L2A ICSRs volume?
Following the implementation of the new EudraVigilance system on November 22nd 2017, many organizations are faced with a daunting obligation of screening L2A ICSRs before deciding whether they should be integrated to their vigilance data. This activity can represent several thousands of cases that need to be screened weekly, usually with only 5% to 40% of these cases being applicable to the organization, incurring massive waste of time and resource.
Today, safety databases are very ill prepared to help users fast track their triage activity. Many organizations still run triage manually or with self-developed scripts that are long to establish and poorly integrated with organizations’ existing vigilance tools. The manual assessment of cases also leads to poor traceability and significant chances of quality flaws and human mistakes.
We have just the tool you need: iTAP (ICSRs Triage, Assessment and Processing)
AB Cube has developed just the right tool to fast track this process. iTAP has been designed to enable automatic assessment and triage of hundreds of ICSRs at once through:
- Import of ICSR batches: hundreds of ICSRs can be imported at once.
- Customizable filters: customized ICSR assessment criteria product per product.
- Automatic case evaluation: based on the selected filters.
- Tracking of your selection: Your decision to import or not to import an ICSR is saved and stored.
- Export to your safety database in R3 or R2 format
Users are invited to create customized ICSRs assessment criteria product per product. The automatic case evaluation based on these criteria help them decide in few seconds which cases should be imported in their database, and identify potential previous versions of the screened ICSRs already existing in their database.
Using iTAP helps organizations reduce the time they spend on triage activities by 85% and brings full guaranty of an error less evaluation. iTAP also introduces the tracking of your decisions in full details and within seconds. All decisions taken through the tool to import or not to import a given ICSR are strictly saved and recorded in reports and remain available at all time.
iTAP can be delivered on a standalone basis (compatible with any safety database) or integrated within the SafetyEasy PV™ database. It can be used to assess cases coming from a variety of sources: L2A, MLM, partners… The tool, delivered through the web can be implemented in just a week: there is really no reason for you not to give it a try!