The modules of HALOPV can be combined in many ways. And you only pay for what you use. Here is the list of all the modules, including the 3 base ones that are always delivered as part of your solution.
Case processing modules
Local intake, case review screens, progress tracking / workflow compliance
Reconciliation with affiliates and partners. Follow-up management
Create and manage device case processing. Intake and export Manufacturer Incident Reports (MIR)- Produce combination product reports for FDA
Integrate with submissions and other tools
Intake and process customer complaints via case screens. Trigger investigations at various entities and track progress + spawn ICSRs, Device cases, Medical information etc. Manage customer feedback/follow-up process
Schedule literature searches periodically. Automate intake from external repositories e.g. PubMed. Perform and track article reviews. Create ICSRs from literature sources
Regulatory and science
Tracking and scheduling of signal management work. Perform periodic and ad hoc detection activities and trigger signal detection activities via built-in signal drill-down dashboard and EVDAS-like reports (or via integrations to 3rd party tools)
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
Intake and process customer complaints via case screens. Trigger investigations at various entities and track progress + spawn ICSRs
Manage customer feedback/follow-up process
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
Manage schedules and workflow progress of reports. Auto-generate report documents, format using Word templates
Supports a wide range of regulatory formats
Oversight and Quality
Manage multiple PSMF versions with separate contributors
Workflow for each annex. Auto-generate annexes, format using Word templates
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
Easy registration of Market Research, Patient Support, Registries, social media etc.
Manage partner roles and spawn reconciliation activities
Manage agreements with partners, affiliates. Auto-generate SDEAs, format using Word templates and standard clauses
Manage audit plans/reports- Track CAPAs globally and visualize effectiveness. Maintain QMS documents and deviations/NCs
Submission compliance tracking, and handle timeliness of local (manual) submissions incl. lateness reasons
Analytics across manual and automated submissions
Medical Information and Communication
Manage communication with patients, authorities and other relevant entities. Use templates for building response documents. Ensure approvals and track exact timelines etc. of responses. Maintain a GxP archive of all interactions
Want to know more, get a demo or take it for a test drive?
We are ready to provide your with further information, and can setup a demo for you, where we take you through a guided tour of the application. If you would like to take it a step further, we also have test environments for you to explore in detail.
Write to email@example.com - we are looking forward to helping your organization!