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[Session 1]eSource and Patient Technology
Session Chair(s)
Misato Kuwagaki, MS
Associate Director, Data Sciences
Eli Lilly Japan K.K., Japan
Tempei Miyaji, MSc
Project Assistant Professor, Department of Clinical Trial Data Management
The University of Tokyo, Japan
Utilization of eSource in clinical development / clinical research is expected to contribute to the efficiency of clinical data management such as elimination of duplicate data entry and improvement of traceability. In addition, utilization of ePRO and devices make the collection of patient’s subjective and objective data in real time. In this session, we introduce case examples on eSource by industry, government and academia, and discuss challenges for the implementation in real practice.
Speaker(s)
TransCelarate eSource Update
Mika Ogasawara
Pfizer R&D Japan G.K., Japan
Data Quality Lead, Biometrics and Data Management
“Smart” Trials, integrating Sensors, Patient Aapps and Analytics: Lessons Learned from 3 Trials
Isabelle de Zegher, DrMed, MD, MS, MSc
b!loba, Belgium
Founder
Real World Data Capture for Clinical Research
Reza Rostami, MBA, RAC
Duke Clinical Research Institute, United States
Associate Director, Quality Management
eSource Data/Non-CRF Data Reliability and Document-Based Inspection
Hitoshi Ozawa, MPharm
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
GCP Inspector, Office of Non-Clininical and Clinical Compliance
Takuhiro Yamaguchi, PhD
Takuhiro Yamaguchi, PhD
Tohoku University Graduate School of Medicine, Japan
Professor, Biostatistics