Without adequate tools, handling a growing number of safety cases can become overwhelming rapidly.
Regulatory Compliance:
Safety Management System guarantees compliance with diverse drug safety regulations, such as E2B(R3), HL7 eMDR, and forthcoming standards. It simplifies adverse event reporting and management while facilitating the creation of essential regulatory documentation.
Cost Efficiency:
Designed to minimize operational expenses, the platform operates on a single database for safety data and functions as a cloud-based service, reducing the necessity for extensive customization or training.
Operational Streamlining:
Safety Management System enhances operational efficiency through its E2B gateway solution and bi-directional data exchange capabilities. Additionally, it offers API connections for seamless integration of data and functionalities.
Workflow Optimization:
The software optimizes workflow management, enabling users to monitor project statuses effectively. Features like email notifications and online dashboards ensure prompt task completion and adherence to submission deadlines.
Safety Management System provides a way to effortlessly manage safety cases and vigilance data, enabling you to compliantly process more cases, faster.
Ensuring compliance with E2B(R3) and HL7 eMDR safety regulations. Streamline workflows, optimize your productivity. Cloud-based pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance software-as-a-service. Used worldwide for guaranteed compliance. Triage and assessment of ICSRs in E2B(R3) with iTAP.
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