STAMFORD, Conn.--()--ArisGlobal, a leading provider of solutions to the life science industry, today announced that CMIC Co., Ltd. has expanded its business by combining its individual case support services and ArisGlobal’s safety information system, ARISg / ARISj to help pharmaceutical customers reduce pharmacovigilance costs and resource needs, including support for MHLW/PMDA regulatory reporting in Japan, which is one of the three ICH regions. CMIC (established in 1985 as Japan’s first contract research organization), provides a wide range of post-marketing and clinical trial services.
“We look forward to working closely with CMIC to offer premium pharmacovigilance services based on a single global safety database and regulatory reporting capabilities to their customers”
ARISg / ARISj is a safety information management software system used by more than 200 companies worldwide. It fully supports all global reporting requirements for EMA and the FDA as well as regulatory reporting requirements for the MHLW/PMDA in Japan. Its proven ability to support all of these authorities allows it to be deployed in a single, global database architecture giving companies complete control and management of all of their safety data information.
“We look forward to working closely with CMIC to offer premium pharmacovigilance services based on a single global safety database and regulatory reporting capabilities to their customers,” explained Deepak Abbhi, President and CEO of ArisGlobal.
“We are very excited to have gone live with ARISg / ARISj as our pharmacovigilance system on cloud platform especially because ARISj fulfills all the regulatory reporting requirements for the MHLW/PMDA in Japan”, stated Mr. Nobuo Nakamura, President of CMIC Co., Ltd.
With increasing pressure to reduce the time to market for drugs, and required compliance to complex and strict global regulatory requirements, highly productive and efficient safety information management has become even more critical for pharmaceutical companies.
Globalization has led to a significant increase in the number of cases to be reported to regulatory authorities in Japan, the United States and Europe. The burden of pharmacovigilance activities at pharmaceutical companies continues to grow and the systems used to collect, transmit and provide safety information among medical institutions, pharmaceutical companies and regulatory authorities must be capable of meeting this challenge.
Implementation of safety information management systems by pharmaceutical/biotechnology companies has become a necessity to streamline activities and enhance both productivity as well as compliance in a rapidly evolving regulatory landscape. However, the hurdles associated with the cost and work required to implement and integrate these systems within a company’s current operations are high, and often prove difficult to manage efficiently.
CMIC is solving this problem for its customers by now offering cloud-based, cost-effective pharmacovigilance services for both post-marketing and clinical activities. As the foundation for this service it has selected ArisGlobal’s safety information system running on agOnDemand, the ArisGlobal cloud-computing platform.
ArisGlobal’s agOnDemand platform provides an easy to implement, low cost-of-ownership cloud environment for all ArisGlobal products. The agOnDemand platform is highly regarded for its reliability and ease of use in more than 60 companies worldwide, including Japan, the United States and Europe.
ArisGlobal (www.arisglobal.com) is a leading provider of integrated software solutions for pharmacovigilance and safety, regulatory affairs, clinical research and medical information. Hundreds of life science companies rely on ArisGlobal’s advanced solutions for maintaining regulatory compliance, workflow automation, improving operational efficiency and easily sharing information around the globe.