Manage global Pharmacovigilance activities smarter and more automated

Truly game changing - and probably the most value-adding tool for PV right now

Traditionally, global PV 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.


Imagine if you were able to orchestrate all the global 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?

HALO is now available in three different modules:

- Products, families and license management
- ICSRs management
- Submissions management
- Organizational entities management  (affiliates, vendors etc.)
- Literature monitoring
- Clinical studies management



- Requirements intelligence
- PSMF management
- Audits and inspections management
- Organizational entities management (SDEAs / PVAs)
- Quality / CAPA management
- Sites and programs management



- Risk management (incl. risk minimization activities)
- Aggregate reporting management (incl. submission tracking)
- Signal management
- Benefit-risk management



The majority of PV organizations have significant challenges maintaining fully compliant processes across their global span of HQ, affiliates, partners and CROs/vendors.  The results are evident, as inspectorates present critical and major findings across industry.


Now you have a tool to do something about it.

Feature highlights

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

Built-in compliance monitoring and management, including CAPAs

Mobile version, ready to travel with you

Ready to access in the cloud. On premise possible.

Built-in automation orchestration, ready to seamlessly incorporate rules based processing, managing unstructured sources with natural language processing (NLP) and reverse completion of language sections with natural language generation (NLG), as well as adding machine learning/AI  into your processes

Integrated with your Office 365 Sharepoint/Onedrive environment. You can edit Word, Excel, Powerpoint documents etc. directly from HALOPV records in workflow and add multiple reviewers.

Highly configurable and easy to setup for your organization’s needs

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 - we are looking forward to helping your organization!

Need a safety database too?

We are experts on Oracle Argus Safety and have a unique offering for pharma companies that want to run a compliant and standardized, yet best-in-class safety database. It is less costly than you would think, and with HALO PVs built-in integrations to Argus Safety, you are on the path of saving a lot of time, at a surprisingly low cost.


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