Formedix announces new training partnership with Hitachi Inspharma
Formedix is pleased to announce it is partnering with Hitachi Inspharma, Ltd. to bring its clinical data standards training to the Japanese pharmaceuticals market.
This exciting new partnership brings together the long-standing standards expertise of Formedix – a leading provider of clinical trial automation software and consultancy services since 2000 – with Hitachi Inspharma, Ltd.’s robust and respected standing in the Japanese market, to further drive the adoption of data standards in the Japanese pharma industry. Designed by experienced standards consultants, Formedix training courses focus on the implementation of CDISC standards across an entire end-to-end clinical trial. The five-day course covers all aspects of CDISC: from CDASH and SDTM to Define-XML and ADaM.
“The Pharmaceutical and Medical Devices Agency (PMDA) will start to accept clinical trial data in CDISC format from October 2016 – creating a pressing need for Japanese companies to embrace the standards,” says Mark Wheeldon, Formedix CEO. “We’ve been working closely with Hitachi Inspharma, Ltd. to create complete, end-to-end training courses that encompass every side of CDISC. With the combined experience in our Consultancy team, Formedix brings a wealth of expertise to the table that is going to be vital to the Japanese market in the coming years.
“This is an exciting time for everyone involved with CDISC-based training in Japan, and we’re happy to be teaming up with a respected company like Hitachi Inspharma, Ltd. to bring our expertise in the subject to a new and receptive audience.
“With the recent opening of the Formedix office in Japan, this partnership will strengthen our ties in Tokyo and provide a strong platform for our future growth.”
“Focusing on CDISC best practice from day one of a clinical trial is vital,” says Masahiro Hayashi, Formedix Business Development Manager, Japan. “Our end-to-end courses have been devised by experienced standards personnel, and they cover every area that Japanese companies will need to look at to comply with the PMDA’s acceptance of CDISC-compliant data. This partnership with Hitachi Inspharma, Ltd. means that the organizations who need to implement CDISC will now be able to access training of the highest standard, easing the transition into a new way of working.”
Read the Japanese Press Release from Hitachi Inspharma, Ltd.
Formedix partner with CAC Croit and Innovion to bring CDISC to Japan
Formedix are pleased to announce a new partnership with CAC Croit and Innovion to provide CDISC services and support for global drug submissions to regulatory authorities. Formedix and Innovion’s extensive experience using CDISC to accelerate trials in the US and Europe for FDA and EMA submissions combined with CAC Croit’s knowledge of PMDA submissions in Japan will bring the benefits of CDISC standards to the Japanese market.