HALOPV helps you protect patient safety and stay compliant with regulations

Introducing HALOPV 3.0

The most comprehensive drug safety (pharmacovigilance) system for pharmas, biotechs and agencies

HALOPV 3.0 was released on 18-JUN-2021. ​See release notes for more information.

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HALOPV is the only tool available that brings you a modular solution for every pharmacovigilance processing need, and integrates with other tools and technologies. The goal is to have everything you need at your fingertips. Automated where ever possible.

The power of having everything at your fingertips

What exactly is HALOPV?

It's a safety database and much more! Includes automation and processing support for PSMF | SDEA | ICSR | Distribution and submission tracking | Aggregate reporting | Signals | Risks | Literature | Regulatory requirements | Complaints | QC | Device vigilance and more. 

Testimonials

HALOPV is a System Masterpiece!

- Director of Drug Safety Analytics, Mid size biotech

It been a pleasure to work with Insife on the contracts for HALOPV, and even though it is complex what we are trying to achieve, I think this has been one of the easiest processes I have experienced in my 20-year career in sourcing.

- Senior Manager, Global Sourcing at big pharma

I look forward to our cooperation and to no longer have to type the same information in 5 different sheets and templates.
It is a great pleasure to be able to talk to you about our wishes and needs and be heard and understood. I had sent a long list of requests, excerpts of my Excel sheets and graphs and I got back precise and customized HALOPV processes. I'm full of optimism!

- PV/Quality Auditor, ALK

Protecting patients from harm

We bring you a solution that is making it easy for your to protect your patients, by a comprehensive support for drug safety processes

Integrate your data

If you have every tried to compile a PV system master file, you will quickly realize how much value there is by integrating data, rather than working off documents. HALOPV welcomes many data feeds by modern integration standards and includes validated adapters for many industry tools.

Automation galore

Built for automation, HALOPV will make it easy for you to intake, process and submit information. Automations are based on artificial intelligence, scripts and rules. 

A great user experience

We constantly listen to our customers and try to optimize how data is presented and edited. Recently, we re-vamped the user interface to meet a modern and clean look-and-feel and make navigation easier

Available modules

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

Reconciliation with affiliates and partners

Follow-up management

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Manage multiple PSMF versions with separate contributors

Workflow for each annex

Auto-generate annexes, format using Word templates

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Submission of ICSRs and other formats, includes gateway capabilities. Track compliance, and handle timeliness of local (manual) submissions incl. lateness reasons

Analytics across manual and automated submissions

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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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Manage schedules and workflow progress of reports

Auto-generate report documents, format using Word templates

Supports a wide range of regulatory formats

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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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Manage agreements with partners, affiliates. Setup Authorities, Investigators, Committees etc. for use in other modules e.g. Submissions

Auto-generate SDEAs, format using Word templates and standard clauses

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GVP Module IX compliant tracking of signal management work

Track periodic and ad hoc detection activities and trigger signal detection activities via built-in EVDAS-like report or via integrations to 3rd party tools

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

Manage partner roles and spawn reconciliation activities

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QMS

Manage audit plans/reports

Track CAPAs globally and visualize effectiveness

Maintain QMS documents and deviations/NCs

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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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Literature

Track local literature screening compliance

Manage sources

Setup queries and integrate with literature databases, e.g. Pubmed

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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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Interactions

Manage communication with Authorities and other relevant entities

Ensure approvals and track exact timelines etc. of responses

Maintain a GxP archive of all interactions

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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 (coming November 2021)

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

Pharma / Biotech

Big or small, HALO PV brings efficiency, compliance and automation to pharma and biotech companies

Partner / service provider / CRO

Bring HALOPV to your clients or extend it with integrated solutions. Be an agent of change with our re-seller program

Agency / Institution

Optimize processes and ease oversight. Build common practices across institutions and share data

 

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