Center for Drug Evaluation, CFDA issues standards and procedures for expedited reporting of Safety Data from Clinical Trials in China
Miami, Florida, May 2, 2018 — ArisGlobal, a leading provider of integrated cloud-based software solutions for life sciences, announced that the China FDA, Center of Drug Evaluation has selected and implemented LifeSphere® Safety MultiVigilance (also known as ARISc) solution for clinical safety and pharmacovigilance (PV) through its local partner. Two contract research organizations (CROs) – DeltaMed Co. Ltd and R&G PharmaStudies have also chosen LifeSphere Safety MultiVigilance as their Safety/PV solution platform to support pharmaceutical companies in China.
Recently, CFDA was reorganized into new State Drug Administration (SDA) and one of the mandates is to implement a system to enforce manufacturer compliance of adverse events.
“We are glad to announce that CFDA or SDA is the ninth national health authority that has selected ArisGlobal as their safety technology solution provider,” said Sankesh Abbhi, President & CEO of ArisGlobal. “We are very pleased to support Center for Drug Evaluation with LifeSphere Safety MultiVigilance (ARISc) and we look forward to supporting all our customers and partners in China to help them comply with the new CFDA regulations for reporting safety data from clinical trials.”
This new regulation in China for drug safety reporting will require advanced technology for compliance by the industry. LifeSphere Safety MultiVigilance is a ready solution as it offers four key technology advantages:
- Full compliance with the latest ICH standards E2B(R3) with ARISc
- Localized cloud service provided to meet regulatory requirements
- A single database with multi-lingual capabilities, including Chinese, English and Japanese
- Built on industry standard practices (ISP) to bring harmonization to deployments and to streamline upgrades
“ArisGlobal welcomes and applauds the significant steps that CFDA has taken in adopting advanced technological software, which helps them align with the ICH standards,” said Dr. Vivek Ahuja, ArisGlobal Vice President, Global Pharmacovigilance. “A combination of ARISc and an eSubmissions Link being offered as a unique service through our partners in China will help both domestic and multinational MAHs achieve the R3 compliance requirement in a sustainable manner.”
China is rapidly becoming a major market for life sciences innovation and development, and the industry will have a need for all ArisGlobal solutions for safety, clinical, regulatory, and medical affairs. The ArisGlobal LifeSphere® platform, services and expertise allows its customers to meet their wide range of requirements for regulatory compliance and patient safety.
Additional Information
For more on LifeSphere Safety MultiVigilance (ARISc): https://goo.gl/DBz61B
About DeltaMed Co. Ltd
DeltaMed Co. Ltd. is a specialized PV Contract Research Organization (CRO) to provide Knowledge Process Outsourcing (KPO) global standard services to pharmaceutical and healthcare companies.
Headquartered in China with multiple location offices in Beijing, Shanghai, Hangzhou, Wuhan and San Diego, DeltaMed offers PV services including Comprehensive Case Management for English and Chinese Case Processing; Literature AE Search; Signal Detection and Risk Management; Postmarketing Study and Pharmacoepidemiology; and Safety Quality Assurance and Training Services.
About R&G PharmaStudies Co. Ltd.
As one of the top clinical CROs in China, R&G PharmaStudies Co. Ltd. offers all the aspects of Clinical Study, Site Management, Medical Affairs, Pharmacovigilance, Biostatistics and Data Management, PK/PD analysis, Big Molecules Analysis, Isotopic Tracing of Drug Metabolism, and Phase I Clinical Study Center.
R&G’s Pharmacovigilance team is a top one as well as in China CRO industry in terms of size and professional level.