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Tuesday, February 8, 2011

7:45 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee



Sponsored by
8:25 Chairperson’s Opening Remarks
Gabriel N. Backianathan, MBE, Senior Product Lead, CTRenaissance Division, Center of Excellence, MaxisIT, Inc. 

8:30 Using Electronic Health Records and Associated Research Databases as a CT Tool

John ParkinsonJohn Parkinson, Ph.D., B.Sc., Director, GPRD, MHRA

Randomizing patients in everyday clinical care under real world conditions is a highly cost-effective and efficient methodology. It offers pharma a new methodology for undertaking post-licensing risk management studies and avoiding some of the pitfalls of observational studies.


9:00 Electronic Health Records & Pharma Research: The Train is Leaving the Station!

Harry FisherHarry Fisher, President, Health ResearchTx

Electronic Health Records (EHRs) are revolutionizing US healthcare and Pharma is slowly, but surely, being impacted. EDC? Informed consent? Phase IV studies? Data Management? eSubmissions? All of these and more will be radically changed by the promise and requirements of EHRs. Any organization considering major strategic or financial investments in the above areas must understand the risk & reward of EHRs prior to making any long-term commitments. This session will focus on the strategic & tactical ways that pharmaceutical companies must change the traditional ways they shepherd compounds through clinical trials and monitor post-approval pharmacovigilance and comparative effectiveness. It will also review the progress of the HL7 Working Committee on EHRs and Clinical Research.

Sponsored by
9:30 Sites+EDC Does Not Have To=Pain: Building eClinical Platforms to Deal with Real-World Scenarios

Wes Childs, Global Head, Operations, Cmed Technology
Osie Gaines III, Director of Business Development, Cmed Technology
Investigator sites have expressed increased frustration with the eClinical platforms used in their day-to-day work.  In order to create an optimal experience, eClinical providers need to re-examine their approach.  Sites need the freedom and flexibility to access clinical trial data from anywhere at anytime as well as manage any type of data for any protocol. They require 24/7 access to all data and functionality. The process-driven user experience should eliminate the problems and annoyances of scheduled downtime and maintenance.  Investigators need clean data at the point of capture that enables all users to work from the same data at the same point in time. Furthermore, busy site staff need a consistently fast experience regardless of their location, local IT infrastructure or a specific point in the trial. Flexible case report forms should support unscheduled visits and exception activities without forcing people to enter needless data.  This session delves into the pain points that sites are experiencing with EDC systems in order to better understand how to overcome them.

10:00 Networking Coffee Break in Exhibit Hall 

10:40 Chairperson’s Remarks 

Sponsored by
10:45 Electronic Source Records - What EDC Should Have Been
Edward S. Seguine
Edward S. Seguine, President, Clinical Ink

EDC does nothing to address the largest cost driver in clinical research - paper source documents.  The advent of electronic source documents will dramatically reduce monitoring costs while solving sites' most aggravating problems with EDC.




11:00 Part I Q&A with FDA: Improving Communication and Understanding for All Stakeholders

Discuss Compliance Issues on the Use of Computerized Systems in Clinical Investigations

Jonathan HelfgottJonathan Helfgott, Consumer Safety Officer, Division of Scientific Investigations, Office of Compliance, CDER, FDA

New FDA Draft Guidance: eSource Documentation in Clinical Investigations 



  • eCRF/ePRO/IVRS Technologies
  • Electronic Health Records
  • Clinical Data Management
  • Standards
  • Remote/Real-Time Monitoring
  • Electronic IRB Recordkeeping

Part II Industry Response and Interactive Discussion: Feedback for the FDA

Solve Data Problems at the SOURCE

Ed SeguineModerator: Ed Seguine, President, Clinical Ink







Darlene KalinowskiDarlene Kalinowski, Associate Director, EDC Operations, Bristol-Myers Squibb Co.







Arnold AdriaanseArnold Adriaanse, CEO, Genova Research







Additional Panelists to be Announced

  • CRO and Vendor Perspective
  • Big Pharma Perspective
  • Biotech Perspective
  • Academic Center Perspective

 Source documents and source data, almost always captured on paper, are the most critical information in a clinical trial, yet there is a surprising lack of understanding about what is permissible and what is possible. The existence of paper source drives the tremendous cost of monitoring and exposes investigators/sponsors to myriad compliance risks. EMRs and eCRFs have been suggested as the answer to the paper source problem but are they really solutions for everyone - sites, regulators, monitors, data management? The views of each of these parties will be represented as we discuss the potential of electronic source records.

  • A non-technical perspective of the business value of alternative approaches to capturing source data electronically
  • The “myths” of EMRs and eCRFs will be reviewed from a practical operational perspective
  • The views of key constituents (sites, regulators, monitors) will identify the key criteria to evaluate the validity of any claims various technology proponents may make about how source data can be captured electronically.

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on your Own

1:25 End of Electronic Data in Clinical Trials 

Stay on for Patient Recruitment in Clinical Trials and Clinical Trial Forecasting, Budgeting, and Project Management 

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