HALOPV is a product developed by insife. Read more about HALOPV on https://insife.com/halopv
Available modules
Local intake, case review screens, progress tracking / workflow compliance
Reconciliation with affiliates and partners
Follow-up management
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
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 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