The COVID-19 Pandemic has impacted the field of clinical data management (CDM) in many ways.
An increased burden on medical institutions, restrictions on movement, and voluntary restraint have meant CDM professionals have been unable to conduct clinical studies, research, and post-marketing surveys as planned. CDM professionals have had to be flexible as the evolving situation has brought about many challenges including restrictions on observations due to patients being unable to visit hospitals, restrictions on monitoring activities (including verifying source documents), and the rise of new methods of communication through remote working. This situation has meant that CDM professionals have been required to adjust quickly to the rapid rise of remote ways of operating. We have also seen the demand for IT infrastructure and data utilization (visualization) increase rapidly.
In July 2019, some 6 months or so before the COVID-19 Pandemic, a notification of a revision to the Good Clinical Practice Guidance (hereinafter referred to as “GCP Guidance”) was issued which made reference to the smooth implementation of clinical trials. The GCP Guidance highlighted the necessity of establishing and executing quality management specifically to deal with computerization in the rapidly growing clinical trial implementation system and to secure the reliability of subject protections and study results. Following this, in April 2020 electronic data submission for applications was fully introduced in Japan. In the future, this will lead to end-to-end data automation and expansion of data utilization. The application of cutting-edge technologies such as regenerative medicine has also boosted collaboration between industry and academia.
With this background, this Workshop will ask, how can clinical data professionals bring about real change and how should we demonstrate leadership in developing new ways of working?
This workshop aims to improve the quality of clinical research and clinical data management activities and will provide meaningful opportunities for networking and information exchange that extend beyond the realms of industry, government, and academia.
Misato Kuwagaki, MS • Consultant, Clinical Laboratory and Data Sciences-eSource/Clinilcal Risk
Eli Lilly Japan K.K., Japan
Keisuke Utsumi • Head, Development Global Medical, Japan Development Division
GlaxoSmithKline K.K., Japan
Yumiko Asami • Principal Biostatistician, Biostatistics
CSL Behring, Japan
Yoko Hattori • Project Assistant Professor
Chiba University Hospital Clinical Research Center, Japan
Yukikazu Hayashi • Exective director, Datascience Division, Associate Director,
A2 Healthcare Corporation, Japan
Kyoko Minamoto • Medical Technologist
National Cancer Center, Japan
Tempei Miyaji, MSc • Project Assistant Professor, Department of Clinical Trial Data Management
The University of Tokyo, Japan
Koji Miyata • Manager, Data Management Group, Data Science Development
Astellas Pharma Inc., Japan
Motohide Nishi, MBA • Vice President, APAC Professional Services and Customer Care
Medidata Solutions K.K., Japan
Mika Ogasawara • Quality Lead, Biometrics and Data Management
Pfizer R&D Japan, Japan
Kotaro Sato • Senior Data Team Lead, Clinical Data Management, Data Sciences
IQVIA Services Japan K.K., Japan
Yoko Tokunaga, MPharm •
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yuko Yamahara • Clinical Data Manager
Osaka University, Japan