Wednesday, March 11, 2009
7:30 am Registration and Morning Coffee
8:00 Chair Opening Remarks
| KEYNOTE SPEAKER |
8:10 Toward Electronic Data: Transformative Efficiencies or Utter Confusion?
 Mark D. Uehling, Editor, ClinPage
Most modern industries have abandoned the use of paper for data collection, storage and transmission. So the heavy usage of paper by clinical and regulatory professionals in 2009 is both a historical curiousity and an operational issue. This overview of recent trends and technologies will address how—and why—forward thinking companies are already moving toward a more nimble, less paper-intensive future. In the main, over time, electronic data will pay dividends on two fronts: meeting investor expectations for ever-higher efficiencies and public expectations for ever-greater informational transparency. |
ELECTRONIC DATA CAPTURE
9:10 Selecting an EDC Vendor: Focus on Business Needs and Vendor Capabilities!
John Aggerholm, eClinical Senior Project Director, Research & Development, Novo Nordisk
9:40 Implementing EDC: Succeed with Change Management!
Jette Klose, M.S., eClinical Senior Consultant, Research & Development, Novo Nordisk
10:10 Networking Coffee Break
10:40 EDC at Full Implementation ‐ How that Affects Operations at Clinical Sites
Steven Olsen, M.S., Principal, SJO Consulting, LLC
11:10 Site Coordinator’s Perspective: Impact of EDC on the Clinical Site
Tracey Barrett, RN, BSN, Executive Director/Clinical Research Coordinator, Clinical Alliance for Research & Education – Infectious Diseases, LLC (CARE-ID)
The conversion from paper CRFs to EDC streamlined the data collection process. Although the overall conversion has had a positive outcome, it also came with trouble spots. Sponsors of clinical research can help to minimize the impact of EDC on the Clinical Site by choosing an appropriate system, building a well thought out database, and providing appropriate training to users.
11:40 Monitoring Clinical Trials Utilizing EDC
Marc Giles, Clinical Research Associate, Clinimetrics Research Associates
The conversion to EDC requires that Clinical Research Associates be highly adaptive. CRAs in all settings (in-house, CRO, independent) need to expand their knowledge base across all EDC systems in order to fulfill their role as a key resource for site personnel. Successful and effective CRAs will keep abreast of changes and developments in EDC processes and integrate these new skills into their
monitoring practices and collaboration with investigative sites.
12:15 pm Luncheon Workshop – Sponsorship Available
For more information, contact Arnie Wolfson, Manager, Business Development, 781.972.5431, awolfson@healthtech.com
1:45 Electronic Data Capture Training For Clinical Research Trials
Tina Pagos, Technology Project Leader, EDC Solutions, Chiltern International
This presentation will provide an overview of training, methodology, and implementation for clinical studies utilizing EDC products. General discussion will include the types of training available and choosing the appropriate type of EDC training for the clinical study. The pros and cons encountered from the site, sponsor, and trainer will be discussed.
2:15 Clockspeed: Using EDC to Ensure Operational Performance Sponsored by 
Chris Connor, Director, Product Management, Phoenix Data Systems
2007 was a tipping point in the adoption of eClinical technology. Market research estimates that over 45% of all new Phase I-III studies were initiated using electronic data capture (EDC) last year. While the acceleration in EDC adoption experienced in 2007 will decrease slightly, EDC adoption for new Phase I-III studies has the potential to exceed 55% in 2008. The life science industry’s ability to absorb this aggressive rate of technology adoption will be challenged, not by the cultural and process barriers that limited adoption prior to 2006, but instead by the ability of EDC to meet the objectives of non-technical users. At the same time, the average time necessary to initiate a new study will need to decrease by more than half. For EDC to continue successfully penetrating the industry, the integration between protocol design, study design and eClinical management must become seamless. If not, EDC will simply amplify study design flaws causing the wheels of the clinical development process to spin ever faster without moving forward.
INTEGRATION OF EDC WITH OTHER CLINICAL SYSTEMS
2:45 Chair’s Remark
2:50 Technology Spotlight Sponsored by 
Electronic Data Lifecycle Management: An Innovative Solution for Managing Clinical Trials Data via Virtual Integration Technology and Operational Data Workflow across Disparate Systems/Data Sources
Peg Regan, President, PharmaPros Corporation
Nick Neri, Vice President of Technology, PharmaPros Corporation
With the proliferation of systems capturing electronic data to support clinical trials (EDC, IVR, ePRO, Labs and Imaging) it has become increasingly difficult for companies to evaluate the status of the trial and to assess the quality and readiness of study data for in-stream analysis.
Adding to this complexity, sponsor teams are interfacing with multiple vendors for a single trial and are looking to collaborate and act on trial status, trends, and results in-stream in order shorten time lines, ensure quality, and decrease costs. In the current technology landscape this is often impossible to achieve. As a result, many companies are asking technology vendors to integrate directly; others are forcing data from one system into another; and others have looked for data repositories to help overcome these obstacles.
The presentation will discuss how a first-in-class solution is enabling companies to manage their trials through automated dataflow management across the many disparate data sources, providing vendors and sponsors alike with the intelligence about their trials in-stream and without impact to their current technology landscape.
3:20 Networking Break and Exhibit Viewing
3:15 Networking Refreshment Break and Exhibit Viewing
3:50 Integration of EDC with other eClinical Systems
Ed Kellar, EDC Implementation Lead Consultant, Wyeth
Wyeth has recently implemented the Rave EDC system. As part of the implementation process we are integrating EDC with approximately a dozen eclinical systems. Lessons learned during this implementation process will be discussed.
4:20 Technology Spotlight - Sponsored by 
Integration of ePRO with other eClinical Systems
Sheila Rocchio, MBA, Vice President of Product Management, PHT Corporation
During a clinical trial, there are several different data streams from the patient. This topic will review what you need to know about electronic Patient Reported Outcomes (ePRO), including the multiple types of ePRO systems, the history of the technologies of ePRO, and the rationale for using ePRO. The talk will then delve into integration of ePRO with other eClinical systems with a discussion focus on:
- Case Studies of types of integration: EDC, IVR, and Adaptive Trial design
- CDISC Standards
- Business Case for integration
| PANEL |
4:50 Panel with Speakers - The Sponsors’ Perspective: Working With EDC
Moderator: Catherine Célingant, Senior Director Clinical Data Management, Millennium, The Takeda Oncology Company
Topics:
- How is ancillary data being handled, e.g., is it going into the EDC system or into a separate database?
- What are companies using as their central data base; pros and cons
- How do companies deal with the use of the internet, e.g., when performance is slow
- How are the EDC systems integrated with IVRS and Trial Management Systems
Panelists:
- John Aggerholm, eClinical Senior Project Director, Research & Development, Novo Nordisk
- Chris Connor, Director, Product Management, Phoenix Data Systems
- Ed Kellar, EDC Implementation Lead Consultant, Wyeth
- Bruce Baily, Senior Director IVRS, Premier Research
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5:20 Networking Cocktail Reception
6:30 Close of Day