Techsol in partnership with Oracle Health Sciences provides world’s leading Safety Data Management and Reporting System – AccelSafety. AccelSafety is offered on a regulatory compliant life sciences specialized cloud to enable higher compliance and increasing efficiency of safety operations.
Pharmaceutical organizations can benefit in many ways with Safety Cloud implementation that provides integrated people, process and system service
Enhance global compliance
With Techsol’s AccelSafety implementation the organizations can enhance their compliance with E2B exchange and periodic reporting. It helps keep products in compliance with the latest FDA, EMA, and PMDA regulations. You can be assured of accurate and timely reporting if each case with the capability to import, export and track ICSRs complying with E2B standards. It also supports comprehensive and fast reporting of adverse events including PSUR, ASR, DSUR, PADER.
Boost efficiency of safety operations
AccelSafety increases the efficiency of individual case processing by providing automation and integrated functionality at global level operations. Argus provides flexible configuration options to ensure enhanced productivity. The system is equipped with worklist management, reporting rules and timelines for better case processing and easy workload distribution.
Central Database Source
AccelSafety provides a global safety database to help increase the accuracy and consistency of data across the globe. This helps in streamlining safety processes and operations at the global level. It also provides a user-friendly interface for the repository of data on cases processed by your affiliates like KPOs and CROs.
Business team availability
AccelSafetyimplementation services deliver a comprehensive business team for consultation, implementation, and validation of safety systems and processes. Our team always stays abreast with the global regulations for the industry. The team comprises of highly experienced members with the technical know-how required for successful implementation of safety systems.
Easy scalability to millions of cases
AccelSafety is a configurable system that provides common code base that facilitates quick and reliable upgrades. This makes scalability a cost-effective activity for your organization. Robust Oracle technology complemented with Techsol cloud ensures system stability for a caseload of millions as well.
Make better informed decisions
AccelSafety provides comprehensive analytics for your pharmacovigilance data. Pre-defined and real-time reporting for clinical trial and post-marketed data makes it easier for the management to take faster and better safety decisions. Timely reporting for risk analysis reduces the occurrence of liability in safety operations.
Configure existing business processes conveniently
AccelSafety can be easily configured to seamlessly blend into your existing business processes ensuring increased efficiency of safety operations, enhanced productivity, and compliance.
Safety Cloud can be expanded to have add-on process capabilities such as Medical Information management, Signal management and Quality Compliant Management systems
|Feature/ Functionality||Techsol Safety Cloud||Partner hosted||CRO/ KPO hosted|
|Fully managed cloud that includes all future upgrades|
|Superior Argus Techno-functional resources/ expertise - Oracle Argus Specialization|
|Safety data access, ownership and database licenses|
|Integrated Cloud – Safety, Medical Information, Signal Management and Product Quality Compliant|
|Service Level Agreements (SLAs):
|FDA 21 CFR Part 11 and GxP compliance. Validated as per GAMP 5 standards|
: Functionality fully available, : Functionality not available, : Functionality partially available, : Functionality available with additional cost
How it is Delivered
Safety Cloud is delivered on SLAs as a fully-managed platform with all future upgrades included.
- 99.9% availability
- Service Desk
Safety Cloud is fully validated as per the GAMP 5 recommendations. The unique validation approach eliminates redundant steps resulting in up to 80% reduction in effort and superior compliance.