Oracle Life Sciences Empirica Description
Oracle Life Sciences Empirica, the leading solution on the market, is used to detect, analyze, and manage safety signals that originate in pre-and post-market drugs and biologics, vaccines and devices, as well as combination products. Oracle continuously researches, develops and advances the state of the art data-mining algorithm and statistical techniques that Empirica uses. Empirica's ability to detect signals with a longer lead-time allows it to provide risk insights 7-22 months earlier than label revision dates based on a time-indexed standard. Safety teams that are responsible for signal management have to face new challenges. They must find hidden signals, assess information from multiple large data sets, and provide better safety information even before clinical trials begin. Learn how new technologies and methodologies, such as artificial intelligent, can help to address these challenges. Read our ebook.
Oracle Life Sciences Empirica Alternatives
Oracle Argus
The leading solution on the market for processing, analyzing and reporting adverse events originating from pre- and post-market drugs and biologics, vaccines and devices, as well as combination products. Improve your case management efficiency by implementing innovative capabilities such as workflow optimization, built-in automation and conditional touchless handling. Argus is a mature and reliable solution that provides proven compliance with drug and vaccine regulations and standards around the world. This includes E2B (R3), E2B (R2), eVAERS, eMDR, MIR, and IDMP. Oracle Analytics is a powerful, flexible AI-powered solution included in Argus Advanced Cloud. It allows users to discover new insights and make more informed decisions. The Medicinal Product Safety teams are under enormous pressure to manage an ever-increasing number of cases, new sources for signal detection data and changing regulations with limited budgets and resources.
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DF mSafety AI
DF mSafety AI, a cloud-based platform, uses AI/ML and automation for a great user interface and efficiency in Safety Case Management, Neutraceutical, Vaccines and Medical Devices.
DF mSafety AI was built on Datafoundry’s Integrated Cloud Platform – DF Safety 4.0, which supports scalable, secure AI/ML-driven Safety Case and Signal Management. It also includes pre-built connectors for enterprise systems and adheres to industry standards and regulatory requirements.
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PvEdge
PvEdge, a cloud-ready software for pharmacovigilance, is designed to provide end-toend compliant safety solutions. It can be used with drugs, devices and vaccines. It provides a comprehensive database for safety that manages pharmacovigilance intake and case processing, submissions AI & Analytics, and safety signals, all on one platform. The system is compliant with existing and future regulations such as 21 CFR Part 11 ANNEX 11 GxP and GDPR. PvEdge uses advanced automation powered by AI algorithms and machine learning algorithms in order to improve the efficiency of drug safety database management. The platform's key features include automated literature scanning, ICSR submissions and smart triage. The platform includes a controlled document system for creating, publishing, and managing pharmacovigilance documentation, as well a risk-based enterprise management system that implements quality processes and records.
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Veeva Vault Safety
Veeva Vault is a modern system for managing individual safety reports. It supports the intake, processing and submission of adverse event reports for clinical and postmarketed products. Sponsors and CROs are able to process global and local adverse events for drugs and biologics as well as vaccines, devices and combination products. The integration of gateway connections and reporting guidelines streamlines the submission management and distribution of cases to health authorities. Central coding dictionary management automates the semi-annual updates to MedDRA, WHODrug and EDQM. Vault Safety integrates pharmacovigilance processes and systems on a single cloud-based platform to provide proactive patient safety. It uses real-time dashboards, reports, and collaboration to provide visibility for adverse events.
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Integrations
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Company Details
Company:
Oracle
Year Founded:
1977
Headquarters:
United States
Website:
www.oracle.com/life-sciences/safety-solutions/empirica-safety-signal-management/
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Product Details
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