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Description
Oracle Life Sciences Empirica stands out as the premier solution for identifying, analyzing, and managing safety signals that arise from both pre-market and post-market drugs, biologics, vaccines, devices, and combination products. Oracle consistently invests in research and development to enhance the cutting-edge data-mining algorithms and statistical methods utilized in Empirica. This innovative approach allows for the identification of signals significantly earlier, offering risk insights as much as 7 to 22 months in advance of the typical labeling revision timelines based on a time-indexed benchmark. Safety teams engaged in signal management encounter increasing difficulties, including uncovering concealed signals, evaluating data from extensive big data sets, and improving the safety information available before the onset of clinical trials. To explore how emerging methodologies and technologies, such as artificial intelligence, can effectively tackle these evolving challenges, be sure to read our ebook, which provides valuable insights and practical solutions.
Description
Veeva Vault Safety is an advanced system designed for the management of individual case safety reports, facilitating the collection, processing, and reporting of adverse events related to both clinical trials and marketed products. This comprehensive platform allows sponsors and contract research organizations (CROs) to handle both global and local adverse events for various categories, including drugs, biologics, vaccines, devices, and combination products. Its integrated gateway connections and established reporting protocols enhance the efficiency of submitting cases to regulatory authorities and sharing information with partners. Additionally, the centralized management of coding dictionaries automates updates for MedDRA, WHODrug, and EDQM on a semi-annual basis. By consolidating pharmacovigilance processes within a single cloud environment, Vault Safety promotes proactive measures in ensuring patient safety. The system also utilizes real-time reports and dashboards, coupled with seamless collaboration, to enhance visibility and ensure compliance regarding adverse event reporting. Ultimately, this innovative solution transforms the approach to safety management in the pharmaceutical industry, fostering a more efficient and effective response to patient safety concerns.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Oracle
Founded
1977
Country
United States
Website
www.oracle.com/life-sciences/safety-solutions/empirica-safety-signal-management/
Vendor Details
Company Name
Veeva
Country
United States
Website
www.veeva.com/products/vault-safety/