HALOPV

Introducing HALOPV 3.0

The most comprehensive drug safety (pharmacovigilance) system for pharmas, biotechs and agencies

It's a safety database and much more! Includes automation and processing of PSMF | SDEA | ICSR | Distribution and submission tracking | Aggregate reporting | Signals | Risks | Literature | Regulatory requirements | Complaints | QC | Device vigilance and more.

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HALOPV 3.0 will be released by the end of May 2021.​

Current release is 2.3.2. See release notes for more information.

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Efficiency and automation across all processes

Available modules

ICSRs

Local intake, case review screens, progress tracking / workflow compliance

Reconciliation with affiliates and partners

Follow-up management

PSMF

Manage multiple PSMF versions with separate contributors

Workflow for each annex

Auto-generate annexes, format using Word templates

Submissions

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

Requirements Intelligence

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

Aggregate reporting

Manage schedules and workflow progress of reports

Auto-generate report documents, format using Word templates

Supports a wide range of regulatory formats

Risks

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

Entities and Agreements

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

Signals

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

Data Collection Programs

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

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.