Establish a Regulatory Compliant Drug Safety Platform with Techsol’s Oracle Argus Safety Expertise
Oracle Argus Safety One Cloud is a comprehensive pharmacovigilance platform that enables pharmaceutical companies to effectively manage safety data and make faster and better patient safety decisions with 100% regulatory compliance. Being the industry’s most preferred safety data management application, Oracle’s Argus Safety Suite supports the intake of adverse event cases, code medical and product terms, perform medical and quality assessments, and generate expedited and periodic reports for health authorities and partners.
Argus is industry-proven worldwide:
Morethan 10 mil Cases Processed Annually
Morethan 400 Clients Globally
Morethan 70% of Drug ICSRs in FAERS
Morethan 90% of Vaccines in FAERS
As a trusted Oracle Partner, Techsol has vast experience in delivering Oracle’s comprehensive suite of Safety and Signal management applications to global clients. Since 2010, we have worked extensively with all the Oracle Argus Safety Cloud models (Standard and Advanced), Oracle B2B and Axway E2B E-Submission Gateways and successfully completed several system implementation, validation, migrations and application version upgrade projects.
Oracle has recognized Techsol Life Sciences multiple times, most recently in the year 2023 for our excellence as a partner in delivering pharmacovigilance solutions globally
Our Capabilities with Oracle Argus Safety
- 15+ years experience in delivering Safety Technology Services to 40+ global clients
- Dedicated team of 75+ seasoned Argus Safety Technical and Functional Consultants
- Ready-to-use Argus Safety Validation accelerators saves 50 to 70% time and effort
- Our Safety Service Desk has provided resolution to 20,000+ application support tickets
- Recognized by Oracle Health Sciences as a preferred Tech Services Provider
- Clients trust us an extended Safety Technology Partner for end-to-end services
Our Argus Safety Technology Consulting Services
With our extensive experience, we provide Oracle Argus Safety implementation and validation services using the GAMP5 Risk-based methodology. Our team can provide consulting guidance to your organization from the initial system requirements definition to post-launch and hypercare.
Safety Management Process Definition
Plan your long-term success by establishing and optimizing your Drug Safety Systems and Processes with our unparalleled subject matter expertise.
As part of the Oracle Argus Safety solution implementation, our subject matter experts can provide knowledge support to:
> Determine the right Argus Safety solution model that fits your organization’s business needs in a cost-effective manner
> Setup the core business processes for safety operations such as ICSR Case Processing, Regulatory Reporting and Safety Signal Management
Argus Safety Implementation / Upgrade & Validation
We have extensive experience and successfully delivered more than 100 global Argus Safety database implementation, setup, configuration and validation projects over the past 15 years. We bring-in proven accelerators, system experts and quality processes to set-up the system in record time and 100% auditable manner. Also, our Argus Upgrade services enable sustained compliance with evolving global regulatory standards, reduced validation effort through reusable test scripts and frameworks and faster time-to-upgrade with minimal system downtime.
- Safety Data Management – Requirements Gathering Completion
- Authoring Systems Requriements Specification
- Setup of Case Management Management workflows
- Validaton Master Plan Development
- Risk Management Report
- IQ / OQ Test Scripts Preparation & Execution
- Incidents & Deviation Management
- Requirements Traceability matrix
- 21 CFR Part 11 Compliance Assessment Report
- EU Annex 11 Compliance Assessment Report
- Validation Closure Report
- End user and administration training
- Project Management
Are you seeking to migrate or freshly implement the Oracle Argus Safety suite to manage safety data? Based on your business need, we can successfully complete the implementation either on Oracle’s Argus Safety Cloud or on Techsol’s AccelSafety Cloud.
Argus Safety Configurations Setup
Our Argus certified SMEs offer extensive technical and functional guidance to configure:
- Products, Studies and associated workflows
- Auto-narratives and letter generation
- Global Reporting Rules
- Optimized Business Rules for lean workflows
- Dictionary Management (MedDRA English & Japan, WHO Drug)
- Users & Roles Administration
- Query & Reporting Services
- Signal Management
Setup Regulatory Reports and Configurations
Based on your global compliance requirements, we can setup and automate the schedule for generating the following regulatory related reports:
- ICH: E2B R3 electronic data submission
- ICH: E2C periodic safety update report (PSUR)
- ICH clinical trial periodic report and EUSAR
- IND and NDA periodic report
- CIOMS II line listing and CIOMS V
- EMEA/CPMP reporting
Argus Safety Data & Systems Migrations
- Data migration Safety Data Migration Strategy & Planning
- Safety Data Migration Execution
- Safety Data Migration Testing & Validation
- More..
We have extensive experience in migrating data in all sorts of formats (csv, xls, E2B, extended E2B, drug safety databases such as Argus, ArisG/ LSMV, Veeva, pvworks etc.). We have also executed multiple turn key projects lifting and shifting the complete database in/ out of Argus from ArisG/ LSMV, pvworks, Veeva etc.
Electronic Submission Gateway Setup
As a trusted partner of Oracle and Axway, we can enable the complete automation of your electronic submissions of safety case data information to Regulatory agencies and your business partners. We have tailored process based on our working experience in setting up and pilot testing with below Regulatory agencies:
- FDA, EMA ( and the associated NCA)
- PMDA
- Health Canada
- MHRA
Argus Safety End-User Training
Based on your business need, our Oracle certified SMEs can deliver the following types of training either with the classroom instructor-led model or by using the ‘Train-the-Trainer’ approach.
> Configurations Management Sessions
> Application Administrator training
> End-user training for Case Management
> Superuser training for System Administration
Argus Safety Service Desk
We provide comprehensive Post-Implementation Support Services – Argus Service Desk (ASD) specifically designed for Argus Safety Cloud where patient safety, data integrity, and regulatory compliance are non-negotiable.
We offer a structured and SLA-driven support framework tailored to the needs of Argus Safety Cloud. Our model combines functional expertise, technical depth, and compliance knowledge to ensure your application continues to operate
within its validated state while supporting evolving business and regulatory requirements.
Our services include:
- Incident and Problem Management
- Regulatory Change Impact Assessment
- Configuration and Change Management
- Routine Maintenance and Monitoring
- User Management and Access Reviews
- Validation Support and Documentation
- Training and SOP Updates
Argus Safety Custom Report Development
We specialize in delivering custom report development and analytics solutions that align with both Pharmacovigilance goals and regulatory expectations. Our services enable you to unlock the full value of safety data while ensuring data integrity, audit readiness, and compliance with global regulations.
- Regulatory & Compliance Reports
- Operational & KPI Dashboards
- Custom Safety and Clinical Analytics
- Cross-System Data Integration
- Self-Service Reporting Enablement
Argus Safety J Consulting Services
Japanese Market Expertise in Drug Safety System Integration and Consulting
With deep expertise in pharmacovigilance (PV) and regulatory requirements in Japan, we offer specialized consulting and system integration services tailored to the needs of Japanese pharmaceutical companies and global organizations operating in the region.
Our team understands the unique compliance standards set by the Pharmaceuticals and Medical Devices Agency (PMDA) and supports clients in implementing and optimizing Oracle Argus Safety to meet local and global regulatory obligations.
- Japanese Regulatory Consulting: Guidance on PMDA requirements, J-DIA format support, and Japan-specific E2B (R3) reporting.
- Argus J System Implementation & Localization: End-to-end deployment of safety databases with localization for Japanese language, workflows, and reporting formats.
- System Integration: Seamless integration with upstream and downstream systems (e.g., EDC, CTMS, ERP) within your IT landscape.
- Data Migration & Validation: Migration from legacy PV systems to Oracle Argus platforms with full compliance and audit readiness.
- Ongoing Support: Post-implementation support, case processing enhancements, and compliance monitoring tailored for the Japanese market.
We combine global PV best practices with in-depth local knowledge to ensure a compliant, efficient, and future-ready safety system landscape for our clients in Japan.
Common Solution FAQs
About Oracle Safety Cloud
The Oracle Safety Cloud platform is hosted and managed completely by Oracle Health Sciences on the Oracle Cloud Infrastructure. As an Oracle Partner, Techsol shall engage with your PV Business Team as a ‘PVTech Services Partner’ to timely complete the implementation, configuration and validation of the Argus & Empirica applications.
About AccelSafety
‘AccelSafety’ is a fully-managed drug safety cloud platform of Techsol that is powered by the Oracle Argus Safety application. It is hosted on AWS and has pre-validated system environments that can be readily used for your safety operations. The AccelSafety platform includes all future application upgrades and 24×7 specialized Argus Safety Support services.
- Case processing
- Expedited reporting
- Periodic reporting
- P&L configuration
- Workflow configuration
- Admin Console configuration
- Report Generation & Analytics
- J lock
- New features included in Argus J
We offer SLA-based technical and functional support for the Oracle Argus Safety application suite. It includes addressing user requests, configuration changes, supporting IT Change Management, dictionary upgrades, generating custom line listings, providing audit support and addressing unforeseen incidents.
Our Full Portfolio of Technology Services
End-to-End Pharmacovigilance Solutions
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