NCSED Chooses Instem’s Integrated Software Suite for Preclinical Studies in China
CONSHOHOCKEN, Pa., Dec 08, 2011 (BUSINESS WIRE) — Instem, a leading provider of early development software applications, announced today that China’s National Center for Safety Evaluation of Drugs (NCSED) has selected Instem’s Provantis(R) software solution suite to automate their preclinical study processes.
The NCSED, a subsidiary of the Chinese State Food & Drug Administration (SFDA), manages and sponsors government and commercial contract research studies throughout the PRC (Peoples Republic of China). The NCSED additionally plays a vital role in the education and training of Good Laboratory Practice (GLP) inspectors and in developing and enforcing Chinese drug safety assessment regulations.
Key facts
— Integrated General Toxicology, Clinical Pathology and Pathology modules to be deployed at the Beijing facility
— Competitive evaluation conducted; Provantis recognized as the overwhelming standard in western facilities and as the leading solution within the PRC
— Provantis offering NCSED compliance to national and western standards, dual language operation and proven protocol-driven automation
— Comprehensive package of implementation services purchased including project management, installation, training and validation
— NCSED to be supported from Instem’s full service office in Zhangjiang Hi-Tech Park, Shanghai, China
“We are delighted to welcome NCSED as our newest client within China,” comments Neil Donaldson, VP Operations EU & Asia. “NCSED is one of China’s leading laboratories and given their specific responsibilities within China’s regulatory framework, we are honored that they have chosen Instem’s Provantis solution to automate their research laboratory.”
Mr Baowen Li, NCSED Deputy Director said, “Using Instem’s Provantis data management solution will support NCSED in our mission to become a world-leading GLP laboratory. We are looking forward to working closely with Instem and to deploying more of their services and solutions in the future.”
As the first western toxicology/pathology software supplier to enter the Chinese market, Instem officially deployed its first China-based system in one of the largest and most advanced vivariums during 2006. Acknowledging analyst projections that the PRC is growing to become the second largest pharmaceutical market in the world, Instem established a full-service office in Shanghai, recruited local staff and has localized the Provantis product suite into Mandarin Chinese. Instem is supporting international organizations and domestic laboratories exclusively serving the PRC.
About NCSED
The NCSED is located in Hong Da Zhong Lu A8 of the Beijing Economic-Technological Development Area and has a total area of 7104.9 square meters. The NCSED is attached to the National Institute for Food and Drug Control (NIFDC), the State Food and Drug Administration (SFDA) of the People’s Republic of China. Its main business is the safety evaluation in the non-clinical study of drugs.
The center can carry out the following types of studies; Single and repeated dose Toxicity, Reproductive and Developmental, Genotoxicity, Carcinogenicity, Local Toxicity, Immunogenicity, Safety Pharmacology and Toxicokinetic Studies.
About Instem
Instem is a world-leading information solutions provider to the life sciences – accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products. In addition to highly focused departmental and scientific solutions, Instem provides a range of business intelligence, planning, workflow management, document management and report compilation applications.
Instem supports clients around the world through full service offices in the United States, United Kingdom and China. Instem additionally has resource locations in India and a full service distributor based in Japan.
To learn more about Instem solutions and its mission, please visit www.instem.com or www.instem-china.cn .
