Examining the challenges involved, benefits to be gained and requirements of unified regulatory and clinical business processes, as well as recommendations for taking the next steps forward.
LifeSphere Safety MultiVigilance (LSSMV) database system has auto-translation capabilities that can translate safety narratives from English to Chinese and vice versa using advanced machine-learning technology.
In order to stay compliant with NMPA requirements (submitting all post-marketing ADRs in ICH E2B (R3) format), drug manufacturers are required to procure an electronic safety database that is.....
Advanced computing methods can be used for safety monitoring and early detection of potential signals of vaccine-related adverse events. These methods work by mining open-access active-moiety databases and vast scientific literature with clinical case studies.
There has been significant changes in the way the EMA expects MAHs to handle ICSRs from the new EudraVigilance system, creating additional work for already busy pharmacovigilance departments
“Driving insights to action” was this year’s DIA Annual conference ...
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 more
A leading global pharmaceutical company selected LifeSphere SUSAR Reporting to streamline safety reporting process. The pharma company worked in partnership with ArisGlobal to ensure greater efficiency with notifications, ability to achieve timely distribution and reduced costs. Read more…
A large CRO with over a billion dollars in revenue struggled to meet the service requirements of clients in a cost-effective and efficient way. The CRO selected LifeSphere SUSAR Reporting to enhance
ArisGlobal is a pivotal partner in the life sciences industry, specializing in solutions that drive drug development, safety monitoring, and regulatory compliance. We collaborate with more than 500 global life sciences companies, CROs, and government health authorities, including leading biopharmaceutical firms and regulatory bodies such as FDA, Health Canada, and NMPA.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China.
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