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.

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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

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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