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HALOPV

You wanted a feature-rich technology to help you make your processes work faster and of higher quality?
Look no further.

NOW
18
PV modules available

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Modules

The modules of HALOPV can be combined in many ways. And you only pay for what you use. Here is the list of all the modules, including the 3 base ones that are always delivered as part of your solution.

Base modules

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Products

Manage product information across families/groups, products and market/clinical licenses

Include active ingredients, NDA information etc.

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Clinical Studies

Manage studies and make them available for the other modules to deliver study-centric

Auto-generate Investigator / Ethics Committee reporting for Submissions

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Entities

Manage the PV ecosystem of organizational relationships. Setup Authorities, Investigators, Committees etc. for use in other modules e.g. Submissions

Case processing modules

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ICSRs (Medicine and vaccine Incidents)

Local intake, case review screens, progress tracking / workflow compliance

Reconciliation with affiliates and partners. Follow-up management

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Device Incidents

Create and manage device case processing. Intake and export Manufacturer Incident Reports (MIR)- Produce combination product reports for FDA

Integrate with submissions and other tools

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Complaints

Intake and process customer complaints via case screens. Trigger investigations at various entities and track progress + spawn ICSRs, Device cases, Medical information etc. Manage customer feedback/follow-up process

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Literature

Schedule literature searches periodically. Automate intake from external repositories e.g. PubMed. Perform and track article reviews. Create ICSRs from literature sources

Regulatory and science

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Signals

Tracking and scheduling of signal management work. Perform periodic and ad hoc detection activities and trigger signal detection activities via built-in signal drill-down dashboard and EVDAS-like reports (or via integrations to 3rd party tools)

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Risks

Global risk register. Manage risk strategy, Benefit-Risk evaluations, risk management documents, risk minimization measures (also locally) and other activities – global as well as local

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Complaints

Intake and process customer complaints via case screens. Trigger investigations at various entities and track progress + spawn ICSRs

Manage customer feedback/follow-up process

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Labelling

Manage labels for products in local markets. Track label updates in local markets and initiate activities, e.g. from risks

Maintain MedDRA CMQ/PT registry for auto-listedness ICSR option

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Aggregate Reporting

Manage schedules and workflow progress of reports. Auto-generate report documents, format using Word templates

Supports a wide range of regulatory formats

Oversight and Quality

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PSMF

Manage multiple PSMF versions with separate contributors

Workflow for each annex. Auto-generate annexes, format using Word templates

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Requirements Intelligence

Manage all local requirements and obligations for Authorities as well as partners and affiliates, across ICSRs, PSURs, SUSAR reporting etc.

Auto-build “reporting rules” and auto-schedule activities according to them

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Data Collection Programs

Easy registration of Market Research, Patient Support, Registries, social media etc.

Manage partner roles and spawn reconciliation activities

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Agreements

Manage agreements with partners, affiliates.  Auto-generate SDEAs, format using Word templates and standard clauses

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Quality

Manage audit plans/reports- Track CAPAs globally and visualize effectiveness. Maintain QMS documents and deviations/NCs

Data Exchange

Submissions

Submission compliance tracking, and handle timeliness of local (manual) submissions incl. lateness reasons

Analytics across manual and automated submissions

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Medical Information and Communication

Manage communication with patients, authorities and other relevant entities. Use templates for building response documents. Ensure approvals and track exact timelines etc. of responses. Maintain a GxP archive of all interactions

Want to know more, get a demo or take it for a test drive?

We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail. 

Write to sales@insife.com - we are looking forward to helping your organization!