Facilitating the standardization of industry best practices
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
New EU regulation on data privacy, the General Protection Data Regulation, shines a Light on the benefits of automation to safeguard patient data when monitoring safety signals and ensuring pharmacovigilance databases can track changes to personal data and create an audit trail to remain GDPR compliant. Read the blogread more
Whether companies like it or not, consumers are discussing their products in social media forums. Comments about adverse events exist on patient forums, and on more generic social forums such as Facebook and Twitter. While much of what is said is not relevant or verifiable, there are safety signals that companies should be paying attention to, and that go to the heart of pharmacovigilance and social media.read more
One of the key roles of pharmacovigilance departments is to understand the benefit-risk profile of a drug. But departments are often bogged down by manual tasks that can absorb time, which might be better spent on value-centric activities. Perhaps the most tedious pharmacovigilance activity is medical literature monitoring (MLM), and as we discussed in our last blog, manual, repetitive tasks are a primary cause of employee dissatisfaction.read more
During a recent webcast, ArisGlobal carried out an insightful survey, which found that visibility and reporting inefficiencies remain a headache.read more
Pharmacovigilance is at a crossroads. The best, most innovative way forward for PV departments may well be automation, as they address the challenges (or market pull factors) and opportunities (or technology push capabilities).read more