Join Bioclinica’s Chief Commercial Officer David Kiger at DIA Japan in Tokyo where he will present a special topic on February 20 at 16:30 in Session 6: Data Management in Investigator-Initiated Clinical Trials and Clinical Research.
Akimitsu Ikeura, Manager, Data Management Group, Biostatistics & Data Management Dept., Daiichi Sankyo Co., Ltd.
Kyoko Minamoto, Clinical Data Manager, Clinical Research Support Center, The University of Tokyo Hospital
After the Pharmaceutical Affairs Law was revised in 2003, investigators and pharmaceutical companies could plan and conduct clinical trials themselves. In the 15 years since passed, compliance with CDISC and other international standards has become indispensable, and individual investigators have increasingly needed to secure funds and other resources from external sources. It is now expected that academic clinical research will be effected by the new Act on Clinical Studies published in April 2017. This session will discuss anticipated developments impacting investigator-initiated clinical trials in academia.
Unstructured and Structured Big Data Convergence for Bridging Clinical, Regulatory, and Commercialization
Data Management in Pharmaceutical industry and Academia (tentative)
Mikio Mori, Section Head, Data Management Section, Data Management Division, Clinical Research Support Office, National Cancer Center Hospital
New Act on Clinical Studies (tentative)
Yasuhiro Fujiwara, MD, PhD, Director General, Strategic Planning Bureau, National Cancer Center