Abstract
PMDA is gearing up to build an advanced workflow of review/consultation using innovative assessment techniques. One who submit for a new drug approval will be required to provide individual data of clinical trials in the forms according to CDISC standards. Though the pharmaceutical industry agree to its goal, due to the unexpectedly fast speed of changes, vairous challenges and worries arise. However, author thinks those can be overcome. Most of the stakeholders confines their attentions to data conversion from data not conforming CDISC standards to data conforming them. Because such a data coversion is very costly and does not contribute to quality of study being conducted, we should stop or avoid it as soon as possible. With the end-to-end implimentation of CDISC standards, we could reduce ex-post cost of data conversion to ZERO and could enhance our process capability of data processing and our interoperability.
