Tag Archive: Japan

Mar 11 2013

The Dawn of a New Clinical Paradigm in the Land of the Rising Sun

A major milestone in the use of stem cells in human therapies was reached in February of 2013.  An ethics committee has authorized the first in-human study utilizing induced pluripotent stem cells (iPSCs) in the treatment of a human disease at the Kobe City Medical Center General Hospital in Japan.  A team led by Dr. …

Continue reading »

Jun 30 2011

Clinical Study Reports to STFs

Module 5 - No STF

When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?”  To explain the importance of Study Tagging Files, we’ve asked Jason Rock, the Chief Technology Officer of GlobalSubmit, to …

Continue reading »