San Francisco, CA (PRWEB) March 24, 2015
November Research Group, LLC, a global leader in the delivery of product safety and pharmacovigilance services and software tools to pharmaceutical and life sciences organizations, today announced the immediate availability of the Japanese localized version of the company’s flagship software application, PRIMO, for Japanese companies and Japanese affiliates of global companies.
This version of PRIMO is fully localized in the Japanese language, providing a single, auditable solution for life science companies to streamline the initial capture of potential adverse event (AE) and product quality information from case reporters. The software enables pharmaceutical companies to fully integrate Japan into the global safety data management and reporting business process while addressing Japan-specific pharmacovigilance challenges.
The Group Inbox feature allows companies to receive Safety Inbox emails right in the database, solving connectivity and security issues by managing the emails directly in PRIMO. The software offers a Correspondence Management system with built-in Japanese language letter and email templates, enabling timely and effective communication between the pharmacovigilance department and case reporters. PRIMO integrates seamlessly with Oracle Argus Safety Japan and EQMS systems, allowing the smooth transfer of data into companies’ core business systems while maintaining the completeness, accuracy, and consistency of the data.
“PRIMO now truly incorporates Japanese colleagues into the global safety reporting and compliance landscape,” said Miho Okawa, Director of Japan Operations at November Research Group. “The Japanese user interface reduces language ambiguity and allows Japanese users to complete local data intake in a quick and easy manner. Meanwhile, PRIMO’s single global database provides real time access to companies’ safety data regardless of where in the world the case is generated, helping Japanese and global life science companies achieve better global compliance.”
In addition to supporting the intake requirements for companies with operations in the United States and Europe, PRIMO now includes functionality designed specifically with Japan’s unique pharmacovigilance challenges in mind. November Research Group’s dedicated Japan practice team along with their expertise in Japan specific projects will ensure the software continues to meet the evolving global regulatory requirements.
About November Research Group
November Research Group is a professional services firm that provides a complete spectrum of software and services in pharmacovigilance to the pharmaceutical and life science industry. The November Research Group team possesses extensive expertise spanning the entire pharmacovigilance industry including: implementation and support for the Oracle Argus Safety Suite, Oracle AERS, and other commercial adverse event reporting systems; requirements specification and system selection; custom software application and tool development; and, software validation. Our flagship software tools are designed to work seamlessly with both Argus Safety and AERS: PRIMO for the streamlined intake, review and triage of adverse events, product complaints and pregnancy registry cases; and WebReports for powerful on demand case search and visualization in English and Japanese. For more information, please visit our website at NovemberResearch.com, call (415) 987-3313, or email: info(at)novemberresearch(dot)com.
Celine Yuan, Marketing Specialist, November Research Group
T: (626) 322-4320 E: celine(dot)yuan(at)novemberresearch(dot)com