LifeSphere Regulatory Archives | ArisGlobal https://www.arisglobal.com/tag/lifesphere-regulatory/ Tue, 12 Nov 2024 13:55:53 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 Survey: Unsustainable Regulatory Workloads Leave No Choice About AI Adoption https://www.arisglobal.com/media/press-release/survey-regulatory-workloads-ai-adoption/ Tue, 12 Nov 2024 13:45:21 +0000 https://www.arisglobal.com/?p=50867 It is now imperative for life science companies to optimize Regulatory Affairs resources using next-generation technology if they are to ensure affordable patient access to treatments and achieve commercial viability, new independent research finds. Boston, Massachusetts – November 12, 2024 – ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, ...

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]]> Why cloud is the only modern option for efficient, high-volume Safety data processing https://www.arisglobal.com/blogs/why-cloud-is-the-only-modern-safety-option/ Thu, 14 Mar 2024 20:01:28 +0000 https://www.arisglobal.com/?p=49422 Sam Wallis, Head of ICSR Case Processing within the Worldwide Patient Safety Operations at Bristol Myers Squibb, will join a Breakthrough 2024 panel discussion on the reality of transitioning Safety/Regulatory systems to the cloud. Here, he provides a glimpse into BMS’s own journey, which he’ll share candidly during the Day 1 debate.

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]]> Regulatory process transformation – including closer collaboration with Safety/PV – starts with cloud-based RIM https://www.arisglobal.com/blogs/regulatory-process-transformation-including-closer-collaboration-with-safety-pv-starts-with-cloud-based-rim/ Sun, 10 Mar 2024 08:03:10 +0000 https://www.arisglobal.com/?p=49405 At Breakthrough 2024 this month, Hans van Leeuwen, Head of RA Data and Systems Excellence at Astellas Pharma, will deliver a keynote on the company’s journey to the cloud for regulatory information management.

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]]> Top Reasons to Attend Breakthrough2024 https://www.arisglobal.com/blogs/top-reasons-to-attend-breakthrough2024/ Thu, 25 Jan 2024 18:44:26 +0000 https://www.arisglobal.com/?p=49329 ArisGlobal’s annual Breakthrough is a one-of-a-kind event bringing together industry leaders, regulatory authorities, the ArisGlobal customer community, and academia to learn about and share what’s next in life sciences! With a clear focus on the next phase of innovation, leaders from around the world are going to share how they’re leveraging the latest evolution in ...

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]]> Transforming Life Sciences Agility on Both Sides of the Regulatory/Safety Sphere: A Year of Health Authority Successes https://www.arisglobal.com/blogs/transforming-life-sciences-agility-on-both-sides-of-the-regulatory-safety-sphere/ Wed, 20 Dec 2023 21:12:46 +0000 https://www.arisglobal.com/?p=49300 Learn how exciting new technological innovations are set to impact how regulatory information management teams work in 2024 and beyond.

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]]> 5 New Innovations Set to Transform Regulatory Information Management https://www.arisglobal.com/blogs/5-new-innovations-set-to-transform-regulatory-information-management/ Wed, 06 Dec 2023 09:13:02 +0000 https://www.arisglobal.com/?p=49237 Learn how exciting new technological innovations are set to impact how regulatory information management teams work in 2024 and beyond.

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]]> Evolving Pharmacovigilance Beyond a Cost Center https://www.arisglobal.com/blogs/evolving-pharmacovigilance-beyond-a-cost-center/ Fri, 13 Oct 2023 06:54:47 +0000 https://www.arisglobal.com/?p=49135 Safety is evolving rapidly. There is a major, emerging opportunity for life sciences organizations that can leverage the latest innovations in technology, automation, and data and analytics to harmonize their ecosystems, generate efficiencies through automation, and unlock strategic, actionable intelligence used to proactively drive better end-to-end safety outcomes. While immense opportunities are available for life ...

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]]> Regulatory Revolution: Unlocking the Era of Connected Insights https://www.arisglobal.com/blogs/regulatory-revolution-connected-insight/ Tue, 19 Sep 2023 19:33:56 +0000 https://www.arisglobal.com/?p=49090 Nothing evolves within a vacuum. While today we can transmit reports, research, and more at the click of a button, this was science fiction fifty years ago. In parallel, regulatory information management was a vague concept with paper submissions being physically transported to reviewers. Regulations were national and required the review of a physical dossier ...

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]]> The Value of Interconnected Data Across the Drug Development Lifecycle https://www.arisglobal.com/blogs/interconnected-data-across-drug-development/ https://www.arisglobal.com/blogs/interconnected-data-across-drug-development/#respond Mon, 17 Jul 2023 05:30:47 +0000 https://www.arisglobal.com/?p=49004 The management of data within organizations has far-reaching effects, as interconnected data provides valuable insights that can yield positive outcomes across various domains. However, drug development takes 8-15 years and incurs costs up to $11 billion. It relies on costly and often inefficient clinical trials, which lack insights into outcomes and side effects. To improve ...

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]]> https://www.arisglobal.com/blogs/interconnected-data-across-drug-development/feed/ 0 Building an Open, Interconnected Regulatory Data Ecosystem https://www.arisglobal.com/blogs/open-interconnected-regulatory-data-ecosystem/ https://www.arisglobal.com/blogs/open-interconnected-regulatory-data-ecosystem/#respond Fri, 07 Jul 2023 00:00:47 +0000 https://www.arisglobal.com/?p=49005 Most regulatory information management (RIM) systems were designed to capture essential regulatory data elements, e.g., drug substance and drug product metadata, and to build compliant submissions, while recognizing the importance of connecting to publishing, document management and registration management as part of an end-to-end platform (E2E), with connected workflows, triggers, and notifications. However, with a ...

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