The most comprehensive drug safety (pharmacovigilance) system for pharmas, biotechs and agencies
Automation and processing of PSMF | SDEA | ICSR | Distribution and submission tracking | Aggregate reporting | Signals | Risks | Literature | Regulatory requirements | Complaints | QC | Device vigilance and more.
The latest edition is HALOPV 2.3 and was released on 12 NOV 2020
Efficiency and automation across all processes
Local intake, case review screens, progress tracking / workflow compliance
Reconciliation with affiliates and partners
Manage multiple PSMF versions with separate contributors
Workflow for each annex
Auto-generate annexes, format using Word templates
Submission compliance tracking, 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
Manage audit plans/reports
Track CAPAs globally and visualize effectiveness
Maintain QMS documents and deviations/NCs
Manage studies and make them available for the other modules to deliver study-centric
Auto-generate Investigator / Ethics Committee reporting for Submissions
Track local literature screening compliance
Setup queries and integrate with literature databases, e.g. Pubmed
Manage product information across families/groups, products and market/clinical licenses
Include active ingredients, NDA information etc.
Manage communication with Authorities and other relevant entities
Ensure approvals and track exact timelines etc. of responses
Maintain a GxP archive of all interactions
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 May 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
A GAME CHANGER
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.
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
“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”