Know HALOPV

PHARMACOVIGILANCE PROCESS ORCHESTRATION AND AUTOMATION

HALOPV is designed to help Pharmacovigilance organizations deliver efficient processing of PV activities, across Safety Operations, Safety Surveillance and QPPV / compliance office departments - globally as well as locally.

A unique and modular platform for ensuring PV process quality and efficiency through a unique offering of artificial intelligence, integrations, scripting, business process management and robotics process automation in a GxP cloud.

HALOPV MODULES

ICSR

Local Intake
Progress tracking and workflow compliance
Reconciliation with affiliates and partners
Follow-up Management

PSMF

Manage multible PSMF versions with separate contributors
Workflow for each annex
Auto-generate annexes, format using word templates

SDEA/PVA

Manage agreements with partners and affiliates
Auto-generate SDEA documents, format using word templates

Requirement Intelligence

Manage all local requirements and obligations
Auto-build 'reporting rules' and auto-schedule activities according to them

Literature monitoring

Track local literature screening compliance
Manage sources
Setup queries and integrate with literature databases

Aggregate reporting

Manage schedules and workflow progress of reports
Auto-generate report documents, format using word templates

Risk Management

Global risk register
Manage risk strategy, risk management, documents, risk minimization measures (also locally) and other activities

Product Management

Manage product information across families/groups, products and market/clinical licenses
Include active ingredients

Submission Management

Submission compliance tracking
Handle local submissions
Analytics across manual and automated submissions

Quality/Audit/CAPA

Manage audit plans / reports
Track CAPA's globally and visualize effectiveness
Maintain QMS documents and deviations/ NC's

Data collection programs

Easy registration of Market Research, Patient Support, Registries, social media etc
Manage Partner Roles

Signal Management

GVP Module lX compliant tracking of signal work
Track periodic and ad hoc detection activities

INTEGRATIONS

HALOPV is 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.

HALOPV also works seamlessly with other tools like Argus Safety and ARISg. Contact us for more information