LifeSphere MultiVigilance (formerly ARISg/ARISc) – A Pharmacovigilance Database for Chinese Regulatory Compliance

May 7, 2018

China is aligning its regulatory environment with that of global standards with an aim to promote innovation, simplify drug development processes and to enhance the efficacy, quality and safety of the drugs approved. With the adoption of ICH guidelines for clinical safety and pharmacovigilance reporting by CFDA, traditional methods of managing adverse event data in excel sheets become redundant as they are non-compliant with the electronic standards defined by the ICH E2B (R3) guideline. Download this whitepaper to learn how:
  • LifeSphere Safety MultiVigilance (ARISc), the drug safety software application fully caters to the pharmacovigilance requirements of Chinese manufacturers
  • LifeSphere Safety MultiVigilance supports compliance with electronic exchange of safety information both during clinical development and post-approval safety reporting in accordance with relevant ICH guidelines
  • LifeSphere Electronic Submission module, allows electronic submission to various health authorities including CFDA
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About ArisGlobal

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 Nava® cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China. For more updates, follow ArisGlobal on LinkedIn and Twitter.

Additional Information

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Contact

Alberto Cantor
ArisGlobal
+1 609-360-4042 | acantor@arisglobal.com