治験における電子データ
ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS
-電子健康記録と治験-
Shared session with Managing Post-Marketing Studies (Phase IIIb-IV) and Registries
Clinical Innovation and Pfizer's Virtual Trial
Craig Lipset, Head, Clinical Innovation, Pfizer Worldwide Research & Development
Beyond the Primary Endpoint: Optimizing Learning from Clinical Trials
Eric Perakslis, Ph.D., Vice President, Research & Development IT, Johnson & Johnson Pharmaceuticals Research and Development
A Full System Approach to Electronic Data and Integration with the Patients' EHR
John Parkinson, Ph.D., Head, GPRD, MHRA Medicines & Healthcare Products Regulatory Agency
OPTIMIZING SAE REPORTING AND AWARENESS
-重篤有害事象（SAE）レポートと認識の最適化-
Trailblazing Trial Approach of Integrating Clinical and Safety Databases Leads to Cleaner Data, More Insightful Trend Analysis
Donna Cohen, Director, Pharmacovigilance, Medical Operations, ZIOPHARM Oncology, Inc.
INTEGRATING SYSTEMS AND SOLUTIONS
-システムおよびソリューションの統合-
Incorporating and Integrating the eClinical Systems and Practices of Two Organizations: Lessons Learned in the Latest Set of Mergers
Timothy Joy, Director, Global Clinical Data Services, Pfizer, Inc.
EDC and Beyond – eXRO
Adrian Hsing, Senior Director, Clinical Operations, Elan Pharmaceuticals
A Medical Data Portal Surfacing Multi-Source Content and Visualizations
Catherine Celingant, Senior Director, Medical Systems Innovative Technologies, Millennium: The Takeda Oncology Company
Clinical Research Investigative Sites and the Use of Electronic Health Record Systems: How to Help Sites Help Themselves
Darlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.
Case Study: Lessons Learned from an EDC Implementation at a Large Academic Cancer Center
Marina Nillni, EDC Program Manager, Dana Farber Cancer Institute
BREAKOUT DISCUSSION GROUPS Interactive Breakout Discussion Groups Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Topics may include:
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