HALOPV is a product developed by insife. Read more about HALOPV on https://insife.com/halopv
HALOPV helps you protect patient safety and stay compliant with regulations
HALOPV 3rd generation drug safety system
The most comprehensive drug safety (pharmacovigilance) system for pharmas, biotechs and agencies
HALOPV 3.1 was released on 30-OCT-2021. See release notes for more information.
.png)
.png)
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 you to protect your patients, by a comprehensive support for drug safety processes
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.
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
Local intake, case review screens, progress tracking / workflow compliance
Reconciliation with affiliates and partners
Follow-up management
Manage multiple PSMF versions with separate contributors
Workflow for each annex
Auto-generate annexes, format using Word templates
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
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
Manage schedules and workflow progress of reports
Auto-generate report documents, format using Word templates
Supports a wide range of regulatory formats
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
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
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
Easy registration of Market Research, Patient Support, Registries, social media etc.
Manage partner roles and spawn reconciliation activities
QMS
Manage audit plans/reports
Track CAPAs globally and visualize effectiveness
Maintain QMS documents and deviations/NCs
Clinical Studies
Manage studies and make them available for the other modules to deliver study-centric
Auto-generate Investigator / Ethics Committee reporting for Submissions
Literature
Track local literature screening compliance
Manage sources
Setup queries and integrate with literature databases, e.g. Pubmed
Products
Manage product information across families/groups, products and market/clinical licenses
Include active ingredients, NDA information etc.
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
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
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