PointCross Life Sciences and CAC EXICARE forge strategic implementation plan
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 EXICAREβs Location in Tokyo Japan and PointCross Life Sciencesβs Location in Foster City, CA, August 24th, 2015 β 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.
βWith 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 complianceβ said Suresh Madhavan, CEO of PointCross Life Sciences. βWe 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.β
Koji Iwamoto, General Manager at BTO Development II, CAC EXICARE, said βFDA 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.β
About CAC EXICARE Corporation
CAC EXICAREΒ 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 WebsiteοΌhttp://www.exicare.com