Mar 10 2010
Instem, a leading provider of early drug development software solutions, announced today that Mitsubishi Chemical Medience Corporation (MCM) has purchased the Provantis preclinical software solution.
“Increasingly Japanese preclinical software organizations such as MCM are performing FDA regulated studies and they are demanding solutions that meet FDA regulatory requirements.”
Following an extensive competitive evaluation MCM decided to replace its existing data collection systems with the fully integrated Provantis solution to manage Preclinical study processes at their research facilities in Kashima and Kumamoto, Japan.
MCM is one of Japan’s largest CROs. They have purchased a wide range of Provantis modules for over 200 users across the 2 sites, including General Toxicology, Clinical Pathology, Pathology, Reproductive Toxicology and Instem’s unique reporting solution – Protocol & Report Assembly.
MCM has also purchased a range of Professional Services to enable them to get quickly up to speed with the Provantis solution and Instem will be working hand in hand with their Japanese distributor CTCLS to ensure that MCM get quick return from their investment in Provantis. CTCLS is one of Japan’s leading providers of integrated R&D support systems for the life sciences and they support Instem solutions through their full service office in Tokyo.
Provantis was chosen after a detailed competitive evaluation and will replace 2 separate systems that are currently in place at MCM.
Dr. Hideaki Hiratsuka, General Manager of MCM’s Safety Assessment Department commented “As part of our company’s expansion plans and our drive to reduce operational costs and further streamline our processes we were looking for a unified system that we could deploy at multiple locations. We were extremely impressed with the capabilities of the Provantis solution.”
Provantis™ is a modern, fully integrated software system for single users and global organizations engaged in non-clinical evaluation studies. Orchestrating every facet of preclinical drug safety assessment, Provantis™ streamlines processes and workflows with straightforward, intuitive functionality for simple or complex studies within a GLP or non-GLP environment
“Instem’s vast experience of working with the US regulators and Part 11 Compliance of its Provantis solution was also a key factor in MCM’s decision to purchase Provantis” said Shigeharu Yamashita, GxP Business Group Manager at CTCLS. “Increasingly Japanese preclinical software organizations such as MCM are performing FDA regulated studies and they are demanding solutions that meet FDA regulatory requirements.”
Neil Donaldson, Instem’s VP Operations EU & Asia said “We are delighted to welcome MCM as our latest Japanese customer. This is an extremely exciting time for Instem and our clients in the Asia-Pacific region. We have a rapidly expanding client base, and, with the recent opening of our full service office in Shanghai, China and our established partnership with CTCLS in Japan we are fully committed to supporting our clients in this region.”
MCM are planning to go live with Provantis for their GLP studies during 2011.
Source:
Mitsubishi Chemical Medience Corporation