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ICSR MANAGEMENT

FROM CASE INTAKE TO FOLLOW-UP MANAGEMENT, HALOPV TAKES THE HARD WORK OUT OF MANAGING THE ICSR PROCES
ICSRS and Follow-ups at a glance

 

This module is a comprehensive toolbox for managing the ICSR life cycle. Capture ICSRs / other safety information, from local or centralized sources – and manage linked follow-ups in an easy and structured way through a web browser. Also, monitor progress of processing according to timelines

You can also manage full E2B(R3) data sets directly in the application or integrate with Arugs Safety or ArisG. Allow for local and global tracking of progress of case processing, also automatically update workflow progress in HALOPV no matter which safety database option is used (HALOPV, Argus Safety or ArisG)

Produce follow-up actions in the application or linked from the safety database (Argus safety supported as standard) to automatically generate tasks for the locally responsible PV personnel in HALOPV

With the rconciliation workflows, you can automatically reconcile case listings between HALOPV and the safety database (Argus safety supported as standard)

Key features​

  • Intake ICSR information in structured forms or unstructured text from affiliates, partners/contractors – or even directly from consumers​

  • Automatically parse emails into structured intake forms​

  • Manage progress of case processing in HALOPV or transfer to Safety Database, .e.g. Argus Safety or ArisG​

  • Use AI translation for e.g. narrative transformation to and from local language​

  • Integrates to the Submissions module, to auto-generate a number of formats including E2B(R3), E2B(R2) including Combination product reporting, MIR etc. ​ This also allows for tracking the number of actual ICSR reports sent out based on requirements (auto-scheduling available if Requirements Intelligence module is enabled).​

  • Reconcile data with external parties via automated listings and possibility to import results​

  • Generate follow-up requests and capture input directly from respondent

IMPROVING THE PROCESSING OF ADVERSE EVENT DATA BETWEEN LOCAL AND GLOBAL ACTIVITIES.

Adverse events and other relevant safety information can come from a multiplicity of sources, across clinical research, markets e.g. through programs, literature, spontaneous reporting. Common for all sources is the presence of source data that needs to be Processed and evaluated.


In reality, many companies end of with several tools and (sometimes quite manual) systems to make up a compliant setup, e.g. collecting emails, forms, pdf’s, data files such as E2b/xml etc. The data potentially arrives from call centers, partners, affiliates, CROs,
distributors, healthcare professionals or even directly from patients. It is complicated and time consuming to encompass all cenarios and for some companies there are significant volumes of transactions, leading to scalability issues too. It is most commonly a central unit at HQ that does the actual case processing / medical evaluation in a safety database.


Further to the complications, there are requirements to pursue follow-up information from the source and document the attempts. Data and processing responsibilities are essentially dispersed across the whole chain, which then leads to additional work reconciling if all data actually ended up in the final reports that were submitted to Authorities and partners – and also make up the basis for signal detection and risk management.


Knowing the importance of being able to deliver a cost effective yet compliant approach to capturing ICSRs and managing follow-ups, we have invested in making a PV tool that improves the processing of adverse event data between local and global activities. It is called HALO PV.