CBI Announces FDA Participation at Upcoming Forum on Clinical Trial Investigator Portals

CBI Announces FDA Participation at Upcoming Forum on Clinical Trial
Investigator Portals

BOSTON, Oct. 28 /PRNewswire/ -- The Center for Business Intelligence (CBI), a
division of Advanstar Communications, is pleased to announce the FDA's
participation in a panel on Regulatory Risks, Compliance and Validation at
their Inaugural Conference on Clinical Trial Investigator Portals, coming up
November 2 - 3, 2009 at the Doubletree Hotel in Philadelphia, PA.

Jonathan Helfgott, Consumer Safety Officer, CDRH Division of Bioresearch
Monitoring of the FDA, will join Munther Baara, Director, Clinical Business
Systems and Processes, Wyeth Pharmaceuticals; Steve Sweeney, Head, Clinical
Operations, Infinity Pharmaceuticals; Diane Nedelkoff, Director, Clinical and
Investigator Portal Solutions, InnovoCommerce; Steve Stowers, Business
Capability Management, R&D Global Development Informatics, Bristol-Myers
Squibb; and Mark Vermette, Senior Director, Global IT CTMS, Quintiles on a
panel discussing risk-based validation, 21 CFR Part 11 compliance, two-way
discussion boards and implementation versus installation.

Other opportune sessions include:

-- Selecting the Development Route for a Clinical Trial Investigator
Portal
(Dory Rodriguez, MBA, Clinical Systems Lead, Takeda Global Research
and
Development, Inc. and Bill Dornback, B.S., Clinical Systems Lead,
Takeda
Global Research and Development, Inc.)

-- Survey Investigators and Clinical End Users to Optimize Portal Design
(Diane Nedelkoff, Director, Clinical and Investigator Portal
Solutions,
InnovoCommerce)

-- Ensuring Sponsor and Site ROI from Portal Implementation (Alison
Shurell, Vice President, Life Sciences Product Marketing, IntraLink)

-- Clinical Trials Portals and Data Integration for Patient Recruitment
Success (Jaime Cohen, Director, Data Management, TCN e-Systems)

-- Employ an Enterprise Clinical Trial Portal to Offer Significant Time
and
Cost Savings (Lisa La Luna, Senior Vice President, Corporate Business
Development and Implementation, ePharmaSolutions)

-- Key Decision Points in the Initiation and Deployment of a Global
Investigator Portal (Steve Stowers, Business Capability Management,
R&D
Global Development Informatics, Bristol-Myers Squibb)

-- Development of a Clinical Trial Operations and Management (CTOM)
Roadmap
Strategy - Leverage Portals to Drive Value and Efficiency (Munther
Baara, Director, Clinical Business Systems and Processes, Wyeth
Pharmaceuticals)

-- From Weeks to Clicks - How Portal Technologies Improve Cycle Times and
Increase Efficiencies of Clinical Trials (Greg Cohee, Director,
eClinical Services, PHARMICA Consulting)

-- Leverage a Portal as an Investigator Relationship Management Tool (Len
Rosenberg, Ph.D., RPh, President and CEO, Diasome Pharmaceuticals)

-- Apply Governance Standards to Utilize the Investigator Portal as a
Gateway to the Enterprise (David M. Rose, M.D., MPH, Research
Scientist,
Office of Research and Development, Department of Veterans Affairs)

Sponsors and Exhibitors include: ePharma Solutions, Pharmica Consulting, TCN
e-Systems, innovocommerce, INTRALINKS, FireCrest Clinical, NextDocs, Compass
IRB and Blue Sky Broadcast.

For more information on this event, please visit http://www.cbinet.com/Portals
or call 800-817-8601. If you would like to apply for a press pass, please
contact Lauren Donoghue at lauren.donoghue@cbinet.com or 339-298-2262.

About CBI:

A subsidiary of Advanstar Communications, CBI Research, Inc. offers
Pharmaceutical and Healthcare conferences that serve senior executives and
government officials by providing a unique platform for highly focused content
and ideal networking opportunities with senior policy- and decision-makers.
CBI events provide you with concrete, real-life examples that you can begin to
apply at your organization immediately for significant impact on costs and
revenue. For more information, please visit http://www.cbinet.com.

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SOURCE Center for Business Intelligence

Lauren Donoghue, +1-339-298-2262, lauren.donoghue@cbinet.com