Argus Safety and HALO PV

Leverage the Cloud for streamlined and cost-efficient safety handling

Argus Safety and HALO PV

Leverage the Cloud for streamlined and cost-efficient safety handling

Making Argus Safety Database accessible for all

Acquiring a working safety database solution can be a costly endeavor. For this reason, Pharma IT has created a multi-tenant and pre-validated solution that enables cost-efficiency, streamlining of processes, and scalability. In this way, Argus Safety becomes accessible for Pharma and Biotech companies of all sizes – regardless of case flow.

Enable timely reporting of expedited safety information

Pharma IT Cloud Argus Safety enables best-in-class handling of individual case safety reports up to, and including: Reporting of safety information to regulatory authorities, ethics committees, and partners around the globe.

HALO PV-integration for business processes and Drug Safety is included

HALO PV can be integrated into Argus, enabling automation of additional PV processes such as Pharmacovigilance System Master File, deviation handling, and compliance monitoring. HALO PV can also be used as a standalone system.

Making Argus Safety Database accessible for all

Enable timely reporting of expedited safety information

HALO PV-integration for business processes and Drug Safety is included

Full list of features

ICSR – Local Intake, Progress tracking and workflow compliance, Reconciliation with affiliates and partners, Follow-up management
Submission Management – Submission compliance tracking, Handle local submissions, Analytics across manual and automated submissions
Literature Monitoring – Track local literature screening compliance, Manage sources, Setup queries and integrate with literature databases
PSMF – Manage Multiple PSMF versions with separate contributors, Workflow for each annex, Auto-generate annexes, format using Word templates

Requirements Intelligence – Manage all local requirements and obligations, Auto-build “reporting rules” and auto-schedule activities according to them
Signal Management – GVP Module IX compliant tracking of signal work, Track periodic and ad hoc detection activities
Product Management – Manage product information across families/groups, products and market/clinical licenses, Include active ingredient
Quality / Audit / CAPA – Manage audit plans/reports, Track CAPAs globally and visualize effectiveness, Maintain QMS documents and deviations/NCs

Safety Data Exchange Agreements (SDEA) / Pharmacovigilance Agreement (PVA) – Manage agreements with partners and affiliates, Auto-generate SDEA documents, format using Word templates and standard clauses
Data Collection Programs – Easy registration of Market Research, Patient Support, Registries, social media etc., Manage partner roles
Risk Management – Global risk register, Manage risk strategy, risk management documents, risk minimization measures (also locally) and other activities
Aggregate Reporting – Manage schedules and workflow progress of reports, Auto-generate report documents, format using Word templates