The Pharma IT Cloud for Safety Management can be leveraged for support of clinical trials and post marketing safety and pharmacovigilance process support.
The Pharma IT Cloud – Argus safety solution is a multi tenant cloud solution which can be used for outsourcing of case processing as well as for in-house case processing. The system has been up and running since Q3 2020.
Data from different customers is fully separated, and onboarding of new customers in the cloud can be done close to instantly.
The Pharma IT Cloud – HALO PV is a multi tenant cloud solution which can be used for supporting the following business processes within safety and pharmacovigilance. The system will be running from Q3 2020.
Data from different customers will be fully separated. On boarding of new customers on the cloud will be almost instantly.
- 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
- Quality / Audit / CAPA – Manage audit plans/reports, Track CAPAs globally and visualize effectiveness, Maintain QMS documents and deviations/NCs
- Aggregate Reporting – Manage schedules and workflow progress of reports, Auto-generate report documents, format using Word templates
- 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
- 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
Does this sound interesting? – please don’t hesitate to contact us