The revolutionary platform for managing all drug safety processes, from ICSR, Risk Management, PSMF etc. Now in version 4 with advanced AI features

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Imagine if you were able to orchestrate and execute all the global pharmacovigilance activities through a single application? What if that application at the same time would cut away all the time spent getting the data to the right people and into the right places - and automate tasks?


Traditionally, global drug safety in a pharma company is constructed around a safety database and a number of additional tools are added to secure affiliate and partner reporting, compliance management, literature monitoring, regulatory intelligence, risk management etc. Lately, automation has become increasingly important, to counter the impact of increased adverse event reporting and overall increasing complexities in managing global operations.

HALOPV is the platform that can handle it all, from ICSRs, SDEAs to PSMF management, Data collection programs etc. It consists of 18 unique modules and keeps on getting more and more advanced. With our 6-monthly release schedule, our customers are ensured a route to get new features at a high frequency.

Protecting patients from harm

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

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. 

Integrate your data

If you have ever 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.

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

Feature highlights

Workflows and process orchestration

Workflow driven process support for global activities across pharma HQs, affiliates, partners, CROs and National Agencies

Built around a powerful workflow engine that will allow for the review, approval and management of any PV process and that can have automator steps perform parts of your process

Mobile friendly

Built on modern web UI, HALOPV is ready to travel with you.


Ready to access in the cloud. That means faster time to spin up environments, better security and lower TCO. And also scales from small to the largest needs

Integrate it 

Powerful data loader from Excel and modern API for integration. Highly integratable, and comes with pre-built integrations for other safety systems such as Argus Safety and ArisG, as well as other systems such as ERP, CMS - and is out of the box working seamlessly with Azure Office 365/Onedrive 

Also, you can edit Word, Excel, Powerpoint documents etc. directly from HALOPV records in workflow and add multiple reviewers.

AWS S3 is available for data storage and file integration

Notifications and reminders

Configurable email notifications, including reminders and escalation and indication of open tasks

Built for automation

Ready to seamlessly incorporate rules based processing, managing unstructured sources with natural language processing (NLP)  as well as adding machine learning/AI  into your processes

Compliance in the box

Built-in compliance monitoring and management, including CAPAs

Un-paralleled data access control

A user access model that allows for determining which organizational entities and roles that will get access to a record – great for global operations and where partners and affiliates have a part to play

Extremely configurable

Easy and flexible to setup for your organization’s needs. In fact, it is the same HALOPV software that runs in some of the largest pharma companies and regulatory agencies as it is in the small biotech with only a few employees. Because it is configurable to the extreme.

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!