Life Sciences thought leadership, news and trends
Chinese Pharmacovigilance: How Auto-Translation and Side-by-Side Dual Language Panels Can Reduce Your Manual Effort
LifeSphere Safety MultiVigilance (LSSMV) database system has auto-translation capabilities that can translate safety narratives from English to Chinese and vice versa using advanced machine-learning technology.
Focus keyword: Chinese pharmacovigilance, safety narrative translation, individual case safety reports. Chinese MedDRA, adverse events
Beat the Clock with Future-Ready ICH E2B (R3) Compliant Safety Database Systems for Chinese Submissions
In order to stay compliant with NMPA requirements (submitting all post-marketing ADRs in ICH E2B (R3) format), drug manufacturers are required to procure an electronic safety database that is…..read more
The Silent Hero: How Advances in Today’s Technology Can Prevent, Assess, Detect, Treat and Predict Health Issues
Advanced computing methods can be used for safety monitoring and early detection of potential signals of vaccine-related adverse events. These methods work by mining open-access active-moiety databases and vast scientific literature with clinical case studies.read more
There has been significant changes in the way the EMA expects MAHs to handle ICSRs from the new EudraVigilance system, creating additional work for already busy pharmacovigilance departmentsread more
A Month Following DIA 2018 Annual Meeting: How Transforming Life Sciences Productivity through Cognitive Platforms Is “Driving Insights to Action”
“Driving insights to action” was this year’s DIA Annual conference theme, and represented a perfect fit for where ArisGlobal LifeSphere® technology is innovating and evolving to strengthen and streamline product lifecycle management for good clinical practice and...read more
This blog recaps ArisGlobal’s recent webcast on the GDPR implementation within medical information systems and examines audience polling results related to readiness, compliance, and moreread more
Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity: Part 2 of 2: How Far Along the Road Are You in Realizing Benefits from Automation in Safety? In Your Organization, Which Areas Would Create Maximum Value?
How far along are you in realizing benefits from automation? What is the biggest hindrance in adopting automation technologies? This two-part blog series analyzes polling responses from a recent DIA webinar and shares ArisGlobal’s thoughts on practical use cases for automation in pharmacovigilance and regulatory.read more
Practical Use Cases of Automation in Pharmacovigilance and Regulatory E-2-E Productivity – Part 1 of 2: What Is Your Greatest Challenge Across the E-2-E Process? How Would You Rate Your Automation Capabilities?
What is the greatest challenge across end-to-end pharma processes? How would you rate your automation capabilities? This two-part blog series analyzes attendee polling responses from a recent DIA webinar and shares ArisGlobal’s thinking about practical use cases for automation in pharmacovigilance and regulatory.read more
LifeSphere Regulatory platform offers unified modules for regulatory information management, IDMP/compliance management, and regulatory submissions tracking. Watch this newscast and discover how LifeSphere Regulatory platform offers innovative end-to-end approach for pharmaceutical regulatory affairs.read more
Newscast: Regulatory 2025: Developing an effective 10-year strategy for technology-enabled regulatory transformation
Preparing to meet regulatory and commercial demands of the future requires a progressive, future-proof approach. As the regulatory department prepares for 2020 and the rest of the decade it must address transformative technologies that take it beyond...read more