ICSR MANAGEMENT

HALOPV TAKES THE HARD WORK OUT OF ACCELERATING, DESIGNING AND IMPLEMENTING PV PROCESSES.

ICSRS AND FOLLOW-UPS

 

  • 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

  • Establish a link between a reporting obligation to an Authority or partner and the ICSR

  • Allow for local and global tracking of progress of case processing, also automatically update workflow progress in HALO PV from the safety database (Argus safety supported as standard)

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

  • Automatically reconcile case listings between HALO PV and the safety database (Argus safety supported as standard)

  • Be inspection-ready with reports that demonstrate that the source registrations and follow-ups are managed and maintained across the organization

  • Is GxP validated* and ready to use in the cloud

*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.

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.

© 2020 Insife