Oracle Argus Safety is a comprehensive, industry-proven pharmacovigilance platform designed for life sciences companies, including pharmaceutical manufacturers, sponsors, and Contract Research Organizations (CROs). It is widely considered the gold standard for drug safety management, supporting both pre-market (clinical trials) and post-market surveillance for drugs, biologics, vaccines, devices, and combination products.
Key Benefits and Capabilities:
- Workflow Automation: Features for intake, case prioritization, field validations, coding, narrative generation, and regulatory submission can reduce manual work by 50% or more, maximizing case processing efficiency.
- Global Regulatory Compliance: The system is continuously updated to ensure compliance with a wide range of global regulations and standards, including ICH E2B (R3), E2B (R2), PMDA, FDA (eVAERS, eMDR), and IDMP.
- End-to-End Case Management: It provides a central, secure platform for documenting all adverse event data, including source documents, follow-up information, medical coding (MedDRA, WHO Drug), medical assessments, and regulatory reports.
- Safety Analytics: Argus Advanced Cloud includes Oracle Analytics, an AI-powered solution that provides deep insights into safety data, workflow metrics, and submission compliance to facilitate faster, informed decision-making and proactive risk management.
- Scalability: The platform is highly scalable, designed to handle millions of safety cases annually and support the needs of companies ranging from small organizations to large global enterprises.
Target Users & Use Cases:
- Drug Safety/Pharmacovigilance teams
- Regulatory Affairs professionals
- Medical Reviewers
- Quality Assurance teams
- CROs managing safety data for clients
The primary use case is to streamline and automate the entire drug safety lifecycle, ensuring timely and accurate regulatory adherence while enabling proactive signal detection.