The constant changing ecosystem of pharmaceutical industry has brought upon great responsibility on the pharma firms to ensure patient safety by employing highly efficient drug safety measures. The key challenges that organizations face are:
- Staying abreast and complaint to the ever-changing safety regulatory reporting requirements across the globe.
- Increasing volume of safety surveillance activities leading to high volume of cases, data management and reporting activities resulting in higher costs.
- Mergers and acquisitions leading to safety data mergers and systems migrations.
- A safety platform that has the ability to scale up on-demand to millions of cases easily of a common challenge with the legacy systems.
- Building a team of techno functional resources with the appropriate know-how of the drug safety landscape is an issue faced by many pharmaceutical organizations.
- Organizations are unable to make quick and better safety decisions due to lack of well-structured and organized analytics and insights.
- Seamless integrations with associated processes such as signal management, medical information and product quality complaint processes.
Is your organization looking for a better way to tackle the above challenges? If yes, read more about Techsol’s Safety Cloud and how it can help organizations streamline safety operations for better compliance and efficiency.
Techsol in partnership with Oracle Health Sciences provides world’s leading Safety Data Management and Reporting System – Argus Safety. Argus Safety is offered on a regulatory complaint 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 services:
|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 Complaint|
|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.