搜尋結果
Learn how leading biotech firm deployed ArisGlobal’s leading drug safety platform as a complement to their adverse event processing in Oracle Argus.
The ICH E2B (R3) guideline adopted by China delineates the requirements for electronic transmission of individual case safety reports (ICSRs) and provides specifications on data elements for reporting adverse events during clinical trials and the post-authorization period.
Once a potential ADR has been identified, the automated tools can detect relevant information and auto-extract it for case creation. This includes information about the person reporting the ADR, the drug used, the ADR experienced, the demographics of the
- Data Mining Within The FDA Adverse Event Reporting System
- How Emerging Risks Associated with Regulated Medical Products Are Detected
- Modern Technologies Impact on Adverse Events Associated with Medicinal Products
The United States FDA uses FAERS (FDA Adverse Event Reporting System), an electronic database of spontaneously submitted adverse events (AEs) associated with drugs and biologic products. For the past 47 years, spontaneous reporting has been the cornerstone of CDER’s (Center for Drug Evaluation and Research) post-marketing drug safety monitoring. Th...
In order to systematically detect and to rapidly evaluate the emerging risks associated with regulated medical products, an integrated electronic system called The US FDA Sentinel Systemis used. It connects the healthcare databases across many data sources. Sentinel enables FDA to proactively assess medical product safety under real-world condition...
Modern technologies are being utilized by regulatory authorities with advanced pharmacovigilance systems, to collect, characterize and evaluate the adverse events associated with medicinal products. The countries with advanced pharmacovigilance systems have made major strides in technologies for spontaneous reporting systems, adverse event database...
Contact the pharmacovigilance experts at ArisGlobal today! Connecting the pull of adverse events and the push of artificial intelligence in pharmacovigilance for patient safety. Read the Blog.
Adverse event reporting software with mobile reporting functionality makes easier for MSLs/ HCPs to identify and report potential adverse events promptly.
LifeSphere Safety is a multi-tenant, cloud platform that leverages cognitive computing to support global pharmacovigilance, clinical safety and benefit-risk management programs. Powered by Nava®Industry-Leading Automation. ArisGlobal’s proprietary cognitive engine, Nava, is woven into the fiber of LifeSphere, extending across our portfolio ...
