STAMFORD, CT—March 4, 2013—ArisGlobal, a leading provider of solutions to the life science industry, continues to be the only commercially available safety system that fully supports all global reporting requirements for EMA (European Medical Agency) and the FDA (US Food & Drug Administration), as well as regulatory reporting requirements for the MHLW/PMDA (Ministry of Health, Labor and Welfare / Pharmaceutical and Medical Device Agency) in Japan, which is one of the three ICH regions. The ability of this unique global safety system (ARISg / ARISj), to support all of these authorities allows it to be deployed in a single, global database architecture giving companies control and management of all their safety data information.
“Pharmaceutical companies who wish to sell their products globally need to meet the safety related governance and regulatory standards that each region and country mandates and this has meant that companies were forced meet their global safety requirements using separate applications and databases and exchanging cases through error-prone and inefficient processes. The ARISg / ARISj solution eliminates the duplication and manual manipulation of this important information for global companies.“ said Deepak Abbhi, President & CEO of ArisGlobal.
Without ARISg / ARISj, a pharmaceutical company would need to use multiple separate systems, with multiple databases, multiple validated environments, multiple configurations and workflows, and then would need to duplicate or double-enter cases, which is risky and inefficient.
With ARISg / ARISj, the pharmaceutical company can implement the most cost effective, proven and complete solution available today.
ArisGlobal is the only provider that has customers who have implemented and validated a worldwide solution creating for them a single, global safety information system that meets the needs of Europe, the United States and Japan. No other vendor in the world can say this or even offers a regulatory compliant global solution.
ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe.
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