‘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.
For core Drug Safety operations & e-submissions
Standard plus Advanced Analytics & Datamart
Includes Enterprise plus Oracle Empirica Signal & Topics
Add-on for integrated Japanese operations
What do we offer clients with AccelSafety?
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
- Dictionary Management (MedDRA English & Japan, WHO Drug)
- Users & Roles Administration
- Query & Reporting Services
- Signal Management
Based on your requirements, we can offer functional domain expertise for:
- Business Process Design for end-to-end Case Management
- Reconciliation with clinical systems
- Setup of Signal Management
- Configuration of process specific compliance reports and productivity dashboards
- Support for reports generation in E2B (R3) & E2B (R2) formats
- Argus DLP integrated safety case summaries
- Validating Argus Safety for 21 CFR Part 11 Compliance
Based on your regulatory needs, we can setup and automate the schedule for generating the following regulatory 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 support the setup and manage electronic submission of regulatory reports for the following Gateways:
- Electronic Submission Gateway using Axway or Oracle
- EMA Gateway
- FDA Gateway
- PMDA Gateway
- Health Canada
- Partner Gateway
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)