It is a need for companies and regulators to manage their pharmacovigilance activities proactively and strategically. The key challenges that organizations face in relation with this are:
- Zero-tolerance drug safety environment calls for new strategies to proactively identify and expeditiously manage safety risks.
- Identifying product safety issues much earlier than regulators.
- Establish pharmacovigilance programs that capitalize on the best available information from multiple data sources.
- A technology platform that provides enhanced, configurable workflow, advanced visualizations and support for an efficient end-to-end signal management process.
Is your organization looking for a better system to manage signal detection to enhance drug safety? If yes, read more about Techsol’s Empirica Signal Cloud and how it can help organizations in effective management of signal detection and trend analysis.
Techsol’s Empirica Signal Cloud solution, powered by Oracle, helps enable identification and monitoring of safety trends to ensure consumer safety and regulatory compliance. This system provides comprehensive management of signal detection in adverse events and product complaints driving the following benefits to the firm:
How it is Delivered
Empirica Signal Cloud is delivered on SLAs as a fully-managed platform.
- 99.9% availability
- Service Desk
Techsol consulting team shall develop custom ETLs to load and aggregate case data from Argus and various data sources. Empirica 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.