アリスグローバルは、中国市場向けのファーマコビジランスのソリューションで現地パートナーを通じて、LifeSphere Safety MultiVigilance(TM)を紹介します

AsiaNet 73348

CFDAの医薬品審評センターが、中国での臨床試験から安全性情報の迅速な報告のために適債基準および手続きをします。

Miami, Florida, May 2, 2018 – アリスグローバル(ライフサイエンス向けのクラウドベースの統合されたソフトウェアのリーディングカンパニー)は、China FDA, Center of Drug Evaluation が LifeSphere Safety MultiVigilance (http://www.arisglobal.com/products/lifesphere-safety-multivigilance-arisg/ ARIScとしても知られている)を選択し、導入・実装を完了したと発表しました。ローカルパートナーである2つのCRO、 DeltaMed Co. Ltd と R&G PharmaStudies もまた、医薬品安全性とファーマコビジランスの観点から、LifeSphere MultiVigilance を彼らのSafety/PV ソリューションプラットフォームとして、また、中国市場における医薬品会社のサポートのために、選択しました。

最近、CFDAは、new State Drug Administration (SDA)と医薬品メーカーの副作用のコンプライアンスを強化するためのシステムを導入する義務を持つ部署との再組織化が実施されました。

「私たちは、9つの国家的な健康に対する権限のあるCFDAあるいはSDAが、彼らの安全性情報管理テクノロジーのソリューションプロバイダーとして、アリスグローバルを選択されたことを喜んで発表します。」と、アリスグローバルのPresident & CEOであるSankesh Abbhi,は述べました。

「私たちは、LifeSphere Safety MultiVigilance (ARISc)によって、医薬品審評センターをサポートすることを非常にうれしく思います。」

「私たちは、CFDAをサポートすること、今後すべての私たちのお客様や中国のパートナーをサポートすること、さらに臨床試験での安全性のデータの報告のCFDAの新しい規制に私たちのお客様や中国のパートナー様が対応できるように手伝うことも楽しみにしております。」

中国における医薬品の安全性報告のための、この新しい規則が医薬品業界におけるコンプライアンスのための高度なテクノロジー、LifeSphere Safety MultiVigilanceは、4つの重要なテクノロジーの利点を提供するソリューションです。

      ・ARIScは、ICHの標準的なE2B(R3)を完全に準拠

      ・規制要件に適合するローカライズされたクラウドサーバーを提供

      ・中国語、英語、日本語を含む多言語をサポートしたシングルデータベースとしての提供

      ・システム展開およびシステムアップグレードの調和をもたらす標準化推進 Industry

      Standard Practices (ISP)に基づいた製品開発による提供

「アリスグローバルは、CFDAに高度なテクノロジーの提供をし、ICH標準に合わせる手助けとなるソフトウェアを採用したことで、CFDAが重要なステップを経たことを大いに歓迎し、拍手を送りたい。」と、アリスグローバルの Vice PresidentであるDr. Vivek Ahuja（https://www.linkedin.com/in/drvivekahuja/ ）,は、述べています。

「中国市場における私たちのバートナーを通じて、特有のサービスとして提供されるARIScとeSubmissionsLinkのコンビネーションは、持続的な手法としてR3コンプライアンスの要件を国内および多国籍のMAHsの両方ともに満たすことになります。」

中国市場は、ライフサイエンスの核心と開発のマーケットとして急速に大きな市場となりつつあります。そして、業界は安全性、医療、規制やメディカルアフェアーズのためにアリスグローバルのソリューションが必要となることでしょう。

ArisGlobal LifeSphere(R)（http://www.arisglobal.com/arisglobal-lifesphere-platform/ ）のプラットフォーム、サービス、スキルは、規制準拠および患者の安全性のために、広い範囲でお客様の適合することが認可されることでしょう。

Additional Information

For more on LifeSphere Safety MultiVigilance (ARISc):  https://goo.gl/DBz61B

About ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way today’s most successful Life Sciences companies develop breakthroughs, and bring new products to market. Our cognitive technology platform, LifeSphere, integrates machine learning capabilities to automate all core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan.  Visit arisglobal.com, or follow ArisGlobal on LinkedIn （https://www.linkedin.com/company/aris-global ） and Twitter（https://twitter.com/Aris_Global ）.

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.

（日本語リリース：クライアント提供）

ArisGlobal Introduces LifeSphere Safety MultiVigilance(TM) Pharmacovigilance Solution for China

PR73348

MIAMI, May 2, 2018 /PRNewswire=KYODO JBN/ --

         Center for Drug Evaluation, CFDA issues standards and procedures for

expedited reporting of Safety Data from Clinical Trials in China

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

partners. 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(https://www.linkedin.com/in/drvivekahuja/),

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 ArisGlobal

ArisGlobal is a visionary technology company that’s transforming the way

today’s most successful Life Sciences companies develop breakthroughs, and

bring new products to market. Our cognitive technology platform, LifeSphere,

integrates machine learning capabilities to automate all core functions of the

product lifecycle. Designed with deep expertise and a long-term perspective

that spans more than 30 years, our cognitive platform delivers actionable

insights, boosts efficiency, ensures compliance, and lowers total cost of

ownership through multi-tenancy.

Headquartered in the United States, ArisGlobal has regional offices in Europe,

India and Japan.  Visit https://www.linkedin.com/company/aris-global, or follow

ArisGlobal on LinkedIn(https://www.linkedin.com/company/aris-global) and

https://twitter.com/Aris_Global.

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.

Source:  ArisGlobal