Electronic Data in Clinical Trials Header

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ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS
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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
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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
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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
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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:

  • Utilization of Electronic Health Record (EHR) data in clinical research: Overcoming regulatory, policy, technical and organizational challenges
  • Approaching data integration for BioTech, Small/Midsize Pharma and Big Pharma: Integrating systems (EDC, IVRS, CTMS) and clinical operations data
  • Increasing clinical trial efficiency through operational data management: Best practices in integrating safety reporting data and your EDC system
  • Incorporating and integrating the eClinical systems and practices of two organizations: Lessons learned in the latest set of mergers
  • Electronic Data Capture (EDC) adoption: Changes in processes and procedures and training staff (sponsor staff, site, CROs)
  • Available technologies and vendor selection: Selecting the right partner for your strategy
  • Regulatory compliance issues on the use of computerized systems in clinical investigations: Qualification of sites that have EMR/EHR systems for source documents; Regulatory audits at sites using EDC
  • Integration of mobile and web-based technologies to enable the patient-centered clinical trial
  • Leveraging technology to enable adaptive trials: Is EDC an absolute necessity?

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EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Clinical Research
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2012 Conference At A Glance