治験業務データの統合と活用：ポータル、データ・ウェアハウス、治験実施施設／治験実施評価基準

DATA INTEGRATION ACROSS MULTIPLE VENDOR
AND INTERNAL PLATFORMS
-ベンダーおよび社内の複合プラットフォームにおけるデータ統合-

Data Warehousing 2.0: Creating an Integrated Data Environment For Clinical Trials

Munther Baara, Senior Director, Development Business Technology, Pfizer

Data Integration Challenges and Considerations

Ramzi Najm, Vice President, R&D Information and Technology Management, Allergan

WEB PORTALS IN CLINICAL TRIALS:
THE FUTURE IS NOW
-治験におけるウェブポータル：未来は現在-

Web Portals in Clinical Trials

Jeanette Teague, Associate Director, eDC Operations, Bristol-Myers Squibb Co.

Portals in Clinical Operation: User Experience at the Center of Attention

Anna Kravets, Director, User Experience Strategy, Merck

IMPROVING TECHNOLOGY UTILIZATION:
CASE STUDIES
-技術活用の改善：ケーススタディ-

The Electronic Clinical Trial Master File at BI

Kristin K. O'Connor, Executive Director, Project Management and Medical Administration, Boehringer Ingelheim Pharmaceuticals

Data Driven Monitoring Visit

Adrian Hsing, Senior Director Clinical Operations, Elan Pharmaceuticals

Data Warehouses: More Than a Version Controlled Data Repository

Greg Moody, Director, Clinical Systems, Millennium: The Takeda Oncology Company

Sponsored by
Clinical Operational Excellence

Eric Lake, Partner, Pharmica Consulting

IMPROVING SITE AND STUDY EXECUTION METRICS
-治験実施施設および治験実施評価指標の改善-

Shared session with Patient Recruitment and Retention and Clinical Trial Forecasting, Budgeting, and Project Management

Where Are We Now? Looking at Industry Metrics to Overcome Bottlenecks of Study Start-Up

Christine Pierre, Founder and CEO, RxTrials, Inc., The Clinical Trials Transformation Initiative (CTTI)

Internal Benchmark Performance Standards and Metrics: Improving Performance and Accountability by Providing Context for Planning and Gap Analysis

Speaker to be Announced

Sponsored by
Data, Data Everywhere, and Not a One to Link

Bonnie Brescia, Founding Principal, BBK Worldwide

Capturing and Analyzing Clin Ops Data to Increase Performance at Site and Organizational Level

Joseph Kim, M.B.A., Clinical Operations Director, Shire

Improving Site and Study Execution Metrics: Measuring Performance in Terms of Monitoring, Site Identification, and Clinical Supply Chain and then Optimizing Trials Accordingly

Speaker to be Announced

BREAKOUT DISCUSSION GROUPS -分科会ディスカッショングループ- 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: Utilizing portals: Integrating data, enabling communications, and optimizing clinical trial operations methodology Clinical Trial Operations and Clinical Data Integration: Building data warehouses to integrate clin ops and clinical data across studies Data mining and warehousing: Strategies for getting more information from existing clinical trial data Improving site and study execution metrics: Measuring performance in terms of monitoring, site identification, and clinical supply chain and then optimizing trials accordingly Internal benchmark performance standards and metrics: Improving performance and accountability by providing context for planning and gap analysis Leveraging technology to optimize trial design, management and analysis: Increasing clinical trial efficiency through operational data management and its re-use Electronic Trial Master Files (eTMFs): Supporting effective study management to ensure data quality and compliance Reducing source data verification/monitoring costs: Achieving cost savings for Sponsors and sites by electronically transferring data from the sites' source documents to sponsor's CRF system

お勧めの月曜午後のショートコース EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Clinical Research -EMR/EHR：臨床研究のための電子健康記録（EHR）データの活用-