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Electronic Data 

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Wednesday, February 6

7:45 am Morning Coffee



EHR AND REGISTRIES AS DATA SOURCE FOR COMPARATIVE EFFECTIVENESS RESEARCH 

Shared Session between Electronic Data in Clinical Trials and Comparative Effectiveness

8:25 Chairperson’s Opening Remarks

Kim Howard, CCDM, Kestrel Consultants

8:30 Utilization of EHR Data and Clinical Trial Registries for Comparative Effectiveness Research

Victor LobanovVictor Lobanov, Ph.D., Director, Informatics Center of Excellence, Johnson & Johnson - Biography 







OptumInsight8:55 Using Cloud-Based EDC Technology to Reduce Late Phase Study Costs and Speed Trial Set-up

Bob FrickBob Frick, Vice President, Technology, Optum - Biography 

Today’s late phase studies are difficult to set up and challenging to manage. With so many sites and patients involved, study oversight and ease of implementation are essential to success. Using cloud-based software can mean the difference between success and failure. In this session, we will discuss how next generation EDC technology allows:
• investigators to enter study data quickly, accurately and cost-effectively
• administrators to manage these large unwieldy projects from anywhere with an internet connection, user ID and password
• sponsors to achieve speedy start up times (with no IT resources needed) because there is no special equipment required and the software requires little to no learning curve

9:10 Measuring Data Quality in Electronic Health Records for Comparative Effectiveness Research

Michael KahnMichael Kahn, M.D., Ph.D., Associate Professor of Pediatrics, Core Director, Biomedical Informatics, Colorado Clinical and Translational Sciences Institute, University of Colorado - Biography 

Electronic health records hold the promise of enabling large-scale observational studies and pragmatic clinical trials. Yet, concerns about the quality of data collected during routine clinical care are widely acknowledged. In this talk, I describe a comprehensive assessment framework and measurement system for evaluating clinical data quality. I describe its implementation in a national distributed comparative effectiveness research network.


inVentiv Health 9:35 Data and Analytics Powered Investigator and Patient Recruitment PlanningElizabeth Ciccio, MSMA, Director, Product Development, Adheris, Inc.
Ritesh Patel, Global Head, Digital, inVentiv Health
The current regulatory environment is creating greater demand for both investigators and patients to support expanding clinical trial requirements. This session explores innovative solutions that leverage unique data assets, analytic capabilities and technologies to identify the right investigators and patients to achieve enrollment targets, within budget and timeline constraints.

Langland10:00 Coffee Break in the Exhibit Hall



UTILIZING TECHNOLOGY TO ACCELERATE STUDY START-UP AND CONSENT 

Shared Session between Electronic Data in Clinical Trials and Global Site Selection

10:45 Study Start-Up Innovation: How Interoperable Digital Identities, Digital Signatures and Cloud Computing at NCI, Bristol-Myers Squibb, and Sanofi are Accelerating the Process

Mollie Shields-Uehling, President and CEO, Staff, SAFE-BioPharma Association - Biography 

The session will discuss an ongoing study involving government (NCI) and industry (Bristol-Myers Squibb, sanofi) cancer researchers showing how use of interoperable digital identities, digital signatures and cloud computing accelerates study start-up while lowering costs. Researchers were provisioned with interoperable US Government and SAFE-BioPharma digital identity credentials which were used to access, amend, exchange, and sign electronic documents placed in the cloud. Prior to the study, the process was delayed by use of courier, fax, travel, etc.

11:10 Case Study: iPAD eConsents

Joseph KimJoseph Kim, Director, Clinical Operations, Shire - Biography 

Paper based consenting is a suboptimal model for a rigorous informed consent process for a number of reasons. For example, it is prone to errors related to version control, date reconciliation, the reconsenting process, and other issues inherent to paper. Most importantly, it does not provide patient centric delivery of the information and concepts at hand. This session will provide an overview and lessons learned from a pilot deployment of multimedia eConsents on the iPAD. The audience will see how this deployment played out in an actual study with the benefit of lessons learned from key stakeholders.

Almac logo small 11:35 Patient Centric Clinical Trials: Voice of the Patient

Joseph BedfordJoseph Bedford, Ph.D., Director, Marketing, Almac Clinical Technologies - Biography 

The emerging trend of patient-centric clinical trials offers opportunities for biopharmaceutical firms to engage patients, minimize disruption of their lifestyles, and improve their satisfaction during the study. But how much do we really know about what patients seek in a clinical trial? This session will present the results of surveys and interviews with over 700 patients that explore patient motivation to participate in trials, preferences for clinical technologies, and insights regarding how a trial can be designed to be patient-friendly.

12:05 pm Lunch on Your Own 

1:25 Close of Conference



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