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ArisGlobal Blogs regulatory affairs regulatory information management

Automation technologies are having a major impact on performance and productivity across industries. In regulatory, these technologies also have the potential to reshape many activities across regulatory, leading to significant productivity gains. While there’s a lot of talk about how automation technologies will create new roles with exciting opportunities, the most powerful impact will be on the data quality and the efficiency with which manual tasks will be accomplished.

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Automation in Pharmacovigilance Data Processing – Do You Trust AI?

On November 28, 2017, ArisGlobal held a webinar with DIA, “How Automation Can Deliver the Holy Grail in Safety: Achieve Productivity, Compliance and Quality”.  In this webinar, we posed a few questions to the audience, and came up with some interesting information.  We took this and spent some thinking about what this means to our clients in the PV ecosystem.

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Taking a Best Practices Approach to Safety Signal Detection and Risk Management

Life sciences companies confront increasingly stringent requirements on safety signal detection and risk management. Regulatory authorities are taking steps to further safeguard patients by requiring companies to take more comprehensive steps to assess and monitor the benefit-risk balance of their products.

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EMA SPOR Working group release the details to the SPOR Change Liaison Group

EMA SPOR Working group release the details to the SPOR Change Liaison Group for bringing Industry on-board the Organisational…

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Technology Considerations to Enable Communication and Collaboration in Medical Affairs Information Management

Our first blog on this topic addressed “The importance of mobility and medical affairs (MA) and its value to the organization is most definitely on the rise.” In this concluding blog we share specific examples of how mobile technology improves MA and arms you with the criteria and questions to ask as you investigate possible medical information solutions.

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Signal Detection & eRMR: New EudraVigilance System Is Almost Here – Are You Ready?

For many companies, signal detection in drug safety pharmacovigilance ranks closely behind regulatory submissions and case management as a key activity because it helps to proactively monitor a product’s risks that come to light from tracking the data submitted to internal and external drug safety databases and platforms.

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ArisGlobal Blogs
Mobility and Medical Affairs: Enabling Communication and Collaboration across the Stakeholder Spectrum – Part 1

“The most competitive pharma companies in the coming decade will be masters of data and digital technologies.” So begins the June 2017 industry brief, “Reinventing the Role of Medical Affairs,” by Bain & Company.

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Newscast: LifeSphere® Mobile MA – Self Service Medical Information Portal for Medical Affairs and Pharmacovigilance

LifeSphere® Mobile MA is the first multi-lingual, self-service medical information portal and mobile app to help…

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Newscast: ArisGlobal Launches LifeSphere® Clinical

LifeSphere® Clinical is the industry’s first pre-validated, unified eClinical research platform for clinical operations and clinical data management. Along with…

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ArisGlobal Blogs lifesphere clinical

From reporting challenges to data integration and data silos with clinical data management, to the continuing search for greater automation,…

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