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  1. MIAMI, FL June 3, 2021 – ArisGlobal, the leading provider of software that automates core product development functions for over 300 global life sciences companies, today released one of the first electronic Trial Master File systems to support a groundbreaking new data standard. ArisGlobal LifeSphere eTMF makes cross-platform file sharing possible by supporting the new […]

  2. With our market-leading automated safety solutions you can bring your safety activities to new heights with LifeSphere, the market leading solution in pharmacovigilance and drug safety software globally. Our proprietary pharmacovigilance drug safety software offers a robust suite of products that are developed and refined through partnerships ...

  3. 2020年1月27日 · ArisGlobal has expanded its partnership with Soterius, Inc., adding LifeSphere® MultiVigilance and LifeSphere® Medical Information to their service-oriented technology stack. MIAMI, FL January 27, 2020 – ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 250 life sciences companies, has expanded its partnership with Soterius ...

    • Business Driver #2: Compliance with ERMR
    • Business Driver #3: Risk of Non-Conformance
    • Questions to Consider

    Along with EudraVigilance, will be the new EMA requirement “eRMR Readiness” whereby both authorities and MAHs will need to download the electronic Reaction Monitoring Report (eRMR) from EVDAS for updates and then send it back to EMA. Signal detection and management capabilities will also be needed. According to EMA, they anticipate that their new r...

    A time for high stress for any MAH is at the point of a regulatory inspection or audit. It’s often at that point that a company will learn how well their systems and processes have helped to ensure their compliance. Over a period of time, taking a look at what non-conformance reports (NCs) have been issued, for example by MHRA, you will likely find...

    With a full view of the benefit-risk landscape of a given medicinal product at hand, life sciences companies can now better evaluate and make informed decisions that ultimately help ensure patient safety. Given the summary highlights addressed in this blog, life science companies need to carefully weigh whether their current processes and approache...

  4. 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. ...

  5. Regulatory Information Management (RIM) refers to an organization or team’s ability to manage and support global regulatory activities. Teams historically stored and managed regulatory information across a variety of systems, databases, and file shares spanning multiple geographic locations. This led to difficulties getting a holistic view of key regulatory activities, especially in a timely ...

  6. One reason for this excitement is the fact that LifeSphere eTMF is the first system to support a new industry data standard designed specifically to make collaboration more efficient. CROs live and breathe efficiency. Anything that can reduce time and costs while improving the quality of research collaborations is highly valuable to CROs, and ...

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