Integrated Drug Safety and Signal Management Solution For Biopharma and CROs
Safety Systems and information technology is an integral part of setting-up and running effective Pharmacovigilance operations for all pharmaceutical and biotech companies, regardless of their size. Our strategic consulting services coupled with our industry leading safety technology solutions help clients to optmize their drug safety operations.
Introducing AccelSafety
AccelSafety’ is a comprehensive pharmacovigilance platform of Techsol built around the Oracle Argus Safety application to address business needs of unified collection, medical assessment and regulatory reporting of clinical & post-marketing safety surveillance data.
Our fully-managed cloud solution facilitates emerging biopharma, device manufacturers and service providers to manage safety data and take informed business decisions in alignment to global compliance requirements.
Key Solution Benefits
- Fast-track Argus Safety Implementation, Migration and Validation with 70% effort reduction
- Use our expertise to migrate your legacy safety data to AccelSafety Cloud in a secure manner
- Establish simplified lean case processing through customized configurations and native automation
- Gain comprehensive operational insights through our advanced Reports, Line listings and Analytics package
- Leverage our 24x7 Argus Safety Service Desk to address user requests, incidents and change management
We have been a trusted Oracle partner for the last 12+ years and have successfully delivered over 150+ projects across 5 continents.
With AccelSafety, clients can choose the most suitable solution model which can meet their business needs.
AccelSafety Project Services
With 12+ years of experience, our Safety Technology experts have worked with emerging/ SMB, generic, innovators, large global pharma and CRO companies to establish and optimize their drug safety operations. We can deliver the following value-add services as part of the ‘AccelSafety’ cloud implementation for your organization.
Argus Safety Implementation / Upgrade & Validation
We have extensive experience and successfully delivered more than 100 global Argus Safety data base 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 Requirements Specification
- Setup of Case Management workflows
- Validation 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
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
AccelSafety – Argus Safety Japanese
Japanese Market Expertise in Drug Safety System Integration and Consulting.
Our team understands the unique compliance standards set by the Pharmaceuticals and Medical Devices Agency (PMDA) and supports clients in implementing and optimizing AccelSafety to meet local and global regulatory obligations.
- Japanese Regulatory Consulting: Guidance on PMDA requirements, J-DIA format support, and Japan-specific E2B (R3) reporting.
- AccelSafety 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.
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
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
> With AccelSafety, our team can complete fast-track Argus Safety implementation, data migration and validation with 70% effort reduction
Safety Sytem Implementation, Migration & Validation
The AccelSafety platform is hosted on a regulatory GxP compliant cloud. All the Argus application feature functionalities are validated in a comprehensive manner. Clients will be provided with the latest IQ/OQ documentation to account for 21 CFR Part 11 compliance.
Business users can quickly execute UAT after undergoing a hands-on training delivered by our Argus Safety Experts.
Solution FAQs
Techsol’s AccelSafety solution is delivered on a validated, GxP compliant, fully-managed cloud platform that is hosted on Amazon Web Services (AWS). It has security and quality certifications such as ISO 9001, ISO 27001, ISO 27017 and ISO 27018 that accounts for information security.
All ongoing systems validation and preventive maintenance of Oracle Argus Safety and associated add-on applications will be managed by Techsol throughout the business lifecycle.
- Techsol owns the responsibility for the end-to-end management of Argus Safety application
- Burden of validation & compliance management is significantly reduced
- Security option with Single sign-on is available
- Includes all future application version upgrades, dictionary upgrades, and security updates
- Considerably reduces Total Cost of Ownership (TCO)
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.
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
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