• Setup submissions and capture information about actual submission timeliness across the global organization, in an easy and structured way through a web browser - and monitor progress of processing according to timelines.

  • Automatically create submission tasks from scheduling in your safety database (Argus safety supported as standard)

  • Easy task notification and completion marking for RA colleagues to secure end-to-end process overview

  • Track electronic submissions from HALOPV in order to automatically keep affiliates and partners informed

  • Be inspection-ready with reports that demonstrate that there is full control of submissions across the organization. Also including PSMF annex performance metrics

  • 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.


Global Pharmacovigilance (PV) submissions are generally divided into ICSRs and aggregate/periodic reporting. PV submissions are increasingly done in electronic, XML based formats, across the board, not least due to the work of setting global reporting standards by the ISO and ICH. Electronic reports submitted in English are typically being handled by a central function at HQ and can to a large degree be automated via well known techniques and distributed via gateways, if the submission volumes deem this necessary.

Unfortunately, not all submissions can be handled that way; about 40% of all ICSRs across global industry are rendered out as structured forms and need manual submission to an Authority or partner. In some of these cases, the information needs to be translated to local language first. Hence, it is a large undertaking for most companies. Considering any type of PV submissions, the problems becomes a challenge of understanding whether all the distributions were in fact done according to the requirement. If a report was not done submitted timely, consequences are typically to raise a form of non-conformity, to document that a compliance breach happened and also the reason for it.

Many companies have setup complex methods for doing monthly compliance checks of ICSR submissions and ensuring that appropriate non-conformities have been raised. The method we typically see are spreadsheets that are emailed to affiliates and partners.
The task to consolidate and reconcile the data becomes a significant task at central level.

Regarding periodic report submission, the landscape looks slightly different than ICSRs - Regulatory Affairs (RA) units are often responsible for the submission task, after receiving the final document from PV. Often the tools that are utilized by RA are not tightly integrated with PV tools, and the end-to-end process overview therefore becomes cumbersome to generate.

Knowing the importance of being able to ensure end-to end submission tracking / compliance, we have invested in making a PV tool that improves this process across local and global activities. It is called HALOPV.

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