OverviewDay 1Day 2 PDF Download Sponsor Press Pass Request Brochure
OverviewDay 1Day 2 PDF Download Sponsor Press Pass Request Brochure
8 Secrets to EDC SuccessBy: Phoenix Data Systems
Full Service EDC as an Alternative to OutsourcingBy: Phoenix Data Systems
CRF: Patient Compliance Triples with e-Diaries
The eCTD – a Six-Month Checkup
Build vs. Buy: Considerations for EDC Investment
Corporate Support Sponsor
Lead Sponsoring Publications
7:30 am Registration and Morning Coffee
8:00 Chair Opening Remarks
9:10 Selecting an EDC Vendor: Focus on Business Needs and Vendor Capabilities!John Aggerholm, eClinical Senior Project Director, Research & Development, Novo Nordisk9:40 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 SitesSteven Olsen, M.S., Principal, SJO Consulting, LLC11:10 Site Coordinator’s Perspective: Impact of EDC on the Clinical SiteTracey 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, firstname.lastname@example.org
1:45 Electronic Data Capture Training For Clinical Research TrialsTina 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 Remark2:50 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 CorporationNick Neri, Vice President of Technology, PharmaPros CorporationWith 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 SystemsEd 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 SystemsSheila Rocchio, MBA, Vice President of Product Management, PHT CorporationDuring 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:
4:50 Panel with Speakers - The Sponsors’ Perspective: Working With EDCModerator: Catherine Célingant, Senior Director Clinical Data Management, Millennium, The Takeda Oncology Company
5:20 Networking Cocktail Reception
6:30 Close of Day
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