‘AccelSafety’ is a comprehensive pharmacovigilance platform of Techsol built around 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.
AccelSafety Solution Models
We have been a trusted Oracle Gold partner for the last 8 years and have successfully delivered over 100+ projects across 5 continents.
With AccelSafety, clients can choose one of the below solution model which can meet their business needs.
AccelSafety Standard
For core Drug Safety operations & e-submissions
AccelSafety Enterprise
Standard plus Advanced Analytics & Datamart
AccelSafety Premium
Includes Enterprise plus Oracle Empirica Signal & Topics
AccelSafety Japan
Add-on for integrated Japanese operations
What do we offer clients with AccelSafety?
| Specialized Argus Safety Configuration Support | Functional Consulting for Safety Business Processes |
Our Argus certified SMEs offer extensive technical and functional guidance to configure:
|
Based on your requirements, we can offer functional domain expertise for:
|
| Setup Regulatory Reports | Facilitate Global Regulatory Electronic Submissions |
Based on your regulatory needs, we can setup and automate the schedule for
|
As a trusted partner of Oracle and Axway, we support the setup and manage electronic submission of regulatory reports for the following Gateways:
|
How is the ‘AccelSafety’ solution delivered?
AccelSafety is delivered on a GxP compliant fully-managed cloud platform hosted on Amazon Web Services (AWS) which has security and quality certifications such as ISO 9001, ISO 27001, ISO 27017 and ISO 27018.
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.
- Fast track implementation with proprietary accelerators for application configuration & case data migration
- Phased approach for global roll-outs
- Continuance guidance from SMEs for business process design
- Business-user training (Train the trainer, Classroom, Remote)
If you looking to migrate your current safety data from your existing legacy application or from your on-premise Argus Application to our AccelSafety cloud platform, our solution delivery team will offer consulting expertise for:
- Legacy data profiling & clean-up
- Source data mapping to ArgusSafety
- Case Migration from various legacy applications in various file formats (XLS, CSV, XML)
- Data harmonization across various sources
- Qualitative, Quantitative & Reusability analysis
- AccelSafety is pre-validated with IQ/OQ and is UAT ready
- Offered with 4 system environments (DEV, VAL, PROD and DR)
- Solution is certified for regulatory compliance (21 CFR Part 11, EU Annex 11)
- Continuous support from SMEs for PQ/UAT execution
- 24×7 ArgusSafety support (Requests, Incidents, Change)
- Preventive Maintenance & Cloud Monitoring
- Technical support for ongoing configurations management
- Functional support for troubleshooting business workflows
Why ‘AccelSafety’ is an ideal choice for Clients?
- We offer 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)
