Establish a Regulatory Compliant Drug Safety Platform with Techsol’s Oracle Argus Safety Expertise
Oracle Argus Safety 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.
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 Global modules (Standard and Enterprise Editions), Oracle B2B and Axway E2B E-Submission Gateways, Oracle Empirica Signal & Topics and successfully completed several system implementation, validation and application version upgrade projects.
Our Capabilities with Oracle Argus Safety
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.
Our specialized validation services for Techsol’s AccelSafety Cloud or Oracle Argus Safety Cloud with the e-Submission Gateway and Oracle Empirica Signal includes:
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
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
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
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)
- Health Canada
How We Can Help
- > 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.
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
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.
‘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
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.