For pharma and biotech companies in Japan, this collaboration will ease the implementation of CDISC standards for electronic regulatory submissions which are a requirement by both the US FDA and Japanese PMDA
CAC EXICARE’s Location in Tokyo Japan and PointCross Life Sciences’s Location in Foster City, CA, August 24th, 2015 — PointCross Life Sciences and CAC EXICARE announced today that the companies have signed a partnership agreement to cooperate on providing services and technology solutions in Japan. As part of the strategic collaboration, CAC EXICARE will be PointCross Life Sciences partner of choice for the reselling, implementation, maintenance and support of PointCross Life Sciences electronic regulatory submission solutions including Data Standardization services. The two companies will also explore other future opportunities to collaborate on the PointCross solutions platform for drug research and development.
“With the FDA bindings guidance issued in Dec, 2014 and the Japanese Ministry of Health, Labour and Welfare issuing the technical notification for electronic data submission and a technical conformance guide in April 2015, pharma companies have only a short time span to implement solutions and processes that ensure compliance” said Suresh Madhavan, CEO of PointCross Life Sciences. “We are excited about partnering with CAC EXICARE to extend our reach in the Japanese market to help pharma companies comply with the new submission requirements.”
Koji Iwamoto, General Manager at BTO Development II, CAC EXICARE, said “FDA has announced submissions in sequence of nonclinical data in format of Standard for Exchange of Nonclinical Data (SEND) based on CDISC for studies that start after December of 2016. With the partnership with PointCross Life Sciences, which provides solution platforms offering SEND specialty services, we aim to expand our one-stop CDISC standardization services to the nonclinical studies industries. By undertaking all CDISC components in both clinical and nonclinical industries, we continue to devote ourselves to reducing the burden on pharmaceutical companies.”
About PointCross Life Sciences
PointCross Life Sciences provides the life sciences industry with data management, analytics and visualization solutions that reduce risks, improve data quality, shorten time to market, and generate better insights from R&D and regulatory data. We are a strategic solution provider to the FDA and to several major Biopharma companies. PointCross was recognized in 2013 as one of Gartner’s Cool Vendors in Life Sciences.
Contact
Pranav Agnihotri, Manager, Business Partnerships
PointCross Life Sciences, Inc.
1291 E. Hillsdale Blvd., Suite 304
Foster City, CA 94404
1-866-468-1900
About CAC EXICARE Corporation
CAC EXICARE is a solutions provider that supports pharmaceutical companies in both contract services and IT systems solutions. From drug discovery and non-clinical activities to post-marketing surveillance, we strongly support all the various processes of the pharmaceutical industry with the best use of IT. We meet the client needs for supports on global business by various activities with our overseas offices. Alliances with domestic and overseas CRO and SMO as well as IT & BPO vendors lead to a strong synergetic effect to respond quickly and flexibly to meet client needs.
CAC EXICARE Website：http://www.exicare.com
Contact
Hiroshi Watanabe
CAC EXICARE Corporation
24-1, Nihonbashi-Hakozakicho, Chuo-ku,
Tokyo 103-0015
+81-3-5623-4676