In Episode 4 of the Life Sciences GenAI Exchange Podcast, Lucinda Smith, Chief Safety Product Officer at ArisGlobal, speaks with Claudia Lehmann, Head of Global Pharmacovigilance Operations at Boehringer Ingelheim, for a rare, behind-the-scenes look at implementing AI in drug safety at scale for one of the world's leading pharma companies. From early planning decisions and regulatory alignment to technical hurdles and change management, Claudia shares real-world lessons learned from deploying AI to transform case intake and processing. Whether you’re starting your AI journey or scaling existing initiatives, this conversation is packed with strategic guidance and insights that shape the future of patient safety. 🎙️ Listen: https://lnkd.in/d7SGcwQ9 #Pharmacovigilance #AIinLifeSciences #DrugSafety #Podcast #GenAI #DrugSafety #PV
ArisGlobal
Software Development
Waltham, Massachusetts 114,327 followers
Innovative Cloud Solutions for Drug Safety, Data & Analytics, Regulatory and Medical Affairs.
About us
ArisGlobal is transforming the way today’s most successful life sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans almost 40 years, LifeSphere® boosts efficiency, ensures compliance, and reduces cost through multi-tenant Software-as-a-Service (SaaS) architecture. Headquartered in Waltham, MA. ArisGlobal has regional offices in Europe, India, Japan, and China.
- Website
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https://www.arisglobal.com
External link for ArisGlobal
- Industry
- Software Development
- Company size
- 1,001-5,000 employees
- Headquarters
- Waltham, Massachusetts
- Type
- Privately Held
- Founded
- 1987
- Specialties
- Pharmacovigilance, Safety Analytics Solution, Signal Detection & Risk Management, ICSR, Regulatory Information Management, eCTD publishing, Regulatory Analytics, ISO IDMP Solution, Regulatory Submissions Tracking, Clinical Data Management (RTSM | EDC | eCOA), Clinical Operations (Trial Disclosure | SUSAR Reporting | eTMF), CTMS, Site Payments, Medical Affairs Platform, Global Medical Information Management, Medical Content Management, Mobile Adverse Event Reporting, Product Complaint Management, Regulatory Publishing, Document Management, and Automation
Locations
Employees at ArisGlobal
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Mike Griffin
Head of UX Design
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Jay Zipursky
UX Strategy, Research, and Design
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Amrit Ray, M.D.
Board Chairman & Director • Physician Researcher and Advocate for Healthcare Access • Former Global President, Head of R&D and Medical, Pfizer
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Eric Jensen
Healthcare Operator | Investor | Innovator
Updates
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GenAI is changing Regulatory Affairs – but are you up to speed? In this on-demand session, hear from Regulatory teams who are actively leveraging GenAI and advanced automation to streamline operations, increase precision, and stay compliant in an ever-changing environment. You’ll see firsthand how you too can drive up to 50% efficiency gains and save your team hundreds of hours by streamlining Regulatory workflows with automation. Featuring speakers: Hans van Leeuwen Global Head Regulatory Operations, Astellas Steve Gens MSOD, Managing Partner, Gens & Associates Michael Sonntag, Director Regulatory Affairs & PV, Wörwag Pharma Watch on-demand now: https://lnkd.in/e4Vmr8BV #RegulatoryAffairs #Pharma #PV #AI #GenAI #Automation #RegulatoryWorkflow
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Safety data is exploding in volume and complexity, and reactive approaches aren’t enough. We need innovative tools today. From ArisGlobal AVP, Signals Product Management Param Gill, PMP, hear the top four reasons you should be leveraging proactive, predictive tools powered by AI/ML that are ready to deploy right now. These tools aren't theoretical. They're here. See how LifeSphere Advanced Signals can put the future in your hands: https://lnkd.in/e-bEz3NF #SignalDetection #SignalManagement #AdvancedSignals #PV #SafetySignals
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The FDA’s adoption of ICH E2B(R3) represents more than just a technical format change. It’s a fundamental shift in how safety data is reported. While regulators like the EMA and PMDA have been using E2B(R3) for years, the FDA’s region-specific implementation introduces a new level of complexity that many organizations may not be ready for. That’s where MultiVigilance comes in. Purpose-built to handle this transition, MultiVigilance helps pharmacovigilance and clinical safety teams move forward with confidence, speed, and full compliance. Read more in our latest blog post: https://lnkd.in/er-5BhAh #LifeSphere #FDA #RegulatoryData #Pharmacovigilance #SafetyTeams #Pharma #PharmaTech #AI #Automation
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Live from New York City, Aman Wasan joins Morgan Waller Scott to highlight the origins and impact of CXO Connect - a premier life sciences event. Today, we are gathering 11 biopharma organizations and leaders from McKinsey & Company, Bain Capital and Nordic Capital to discuss what's next for the industry in the era of Al transformation. Bringing together senior leaders in R&D IT across biopharma creates a rare opportunity: candid, pragmatic dialogue about the realities of GenAI and emerging technologies. By aligning on shared challenges and priorities, we can accelerate meaningful innovation across the industry. #LifeSciences #CXOConnect #RDIT #PV #GenAI #Pharma #Biopharma #Innovation
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Another step forward for AI-enabled innovation in APAC. ✅ We’re proud to share that a leading Japanese pharmaceutical company has adopted our next-generation LifeSphere Safety pharmacovigilance platform - an important milestone for ArisGlobal’s expanding footprint in Japan and the APAC region. The new deployment will include LifeSphere MultiVigilance, Reporter, and Business Intelligence. By upgrading from a legacy system to LifeSphere’s modern, multi-tenant cloud platform, the organization will now have the flexibility , scalability and automation-readiness they need to meet today’s regulatory demands by embracing AI-enabled safety operations. Read more about the implementation, which spans global operations, in today’s press release: https://lnkd.in/eudQ5-99 #LifeSphere #pharmacovigilance #SafetyOperations #LifeSciencess #pv #Pharma
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Big news: #AGBreakthrough returns February 10–11, 2026 in Madrid, Spain - and registration is officially open! This year’s Breakthrough theme, Operationalizing AI, will explore how life sciences leaders are successfully embedding AI into core business workflow across Pharmacovigilance, Regulatory, Quality, and Medical Affairs. Register today and don’t miss out on: 🔹 Actionable, real-world insights from leading global pharma orgs 🔹 Keynotes and panels with industry experts and tech leaders 🔹 Live demos of transformative AI-powered tools in action Spots are limited - secure your spot now: https://lnkd.in/eBSKGGTp #lifesciences #pharmacovigilance #AGBreakthrough26 #regulatoryaffairs #safetyoperations #pv #pharma #drugsafety
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ArisGlobalは、製薬業界における文献モニタリングを生成AIがどのように変革しているかを探求するウェビナーへ、8月19日(火)日本時間午後3時よりご参加いただけるようご案内申し上げます。 ✔️ 繰り返し作業を自動化し、規制コンプライアンスに対応 ✔️既存のPV IT環境への影響を与えずにイノベーションを導入する ✔️ チームが戦略的な業務に集中できる環境を整える ライブデモで実際のアプリケーションをご覧いただき、当社の久保田 健と平形 実生子より、Literature Intelligenceを使って生成AIによるイノベーションをどう実現するかについて説明します。 この機会をお見逃しなく、今すぐご登録くさだい!https://lnkd.in/eVW_inpS -- What if you could reduce literature screening times from days to hours? We invite you to join ArisGlobal on August 19 at 3 PM JST for a live webinar exploring how GenAI is transforming literature monitoring across the pharmaceutical industry. ✔️ Automate repetitive tasks and accelerate regulatory compliance ✔️ Adopt innovation without disrupting your PV IT environment ✔️ Free up your team to focus on strategic, high-value work See the technology in action during a live demo, and hear from Specialists Ken Kubota and Mioko Hirakata on how to implement GenAI-driven innovation with Literature Intelligence. Sign up here: https://lnkd.in/eVW_inpS #Japan #Webinar #LiteratureIntellgience #GenAI #AI #Pharma
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Next week, ArisGlobal will host CXO Connect: an exclusive, invite-only forum of top pharma executives to discuss operationalizing GenAI and Agentic AI across the R&D IT ecosystem. There’s been no shortage of bold claims about what GenAI can do in drug safety and regulatory operations. But behind the scenes, most teams are still in early stages—experimenting with narrow use cases, running into integration hurdles, and trying to figure out where these tools actually make work better, not just louder. The session will facilitate an honest dialogue amongst leaders from 11 different organizations, including pharma IT thought leaders from McKinsey & Company, Bain Capital and Nordic Capital. Discussions will include topics like AI adoption & maturity, regulatory considerations, and AI governance, plus a behind-the-scenes discussion about the NavaX solutions on our roadmap. CXO Connect reflects our ongoing commitment to innovation, thought leadership, and collaboration with the brightest minds in life sciences and beyond. #CXOConnect #AIinLifeSciences #PharmaInnovation #GenAI #DigitalTransformation #ArisGlobal
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LifeSphere Unify connects teams across Safety, Regulatory, and Quality - enabling real-time data exchange, breaking down silos, and ensuring critical insights drive impact across domains. As CEO Aman Wasan explains, LifeSphere Unify delivers strategic impact by aligning with the way pharma is evolving—breaking down barriers between domains and enabling true R&D compliance integration. Watch the video and explore how Unify drives cross-functional innovation: https://lnkd.in/ePihR25X #LifeSphereUnify #ArisGlobal #Pharma #PV #Pharmacovigilance