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. HALOPV also comes in a Service Provider edition and a Global Regulatory Intelligence Club for PV edition.

HALOPV is 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

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