Navigation Links
CBI Announces FDA Participation at Upcoming Forum on Clinical Trial Investigator Portals
Date:10/28/2009

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.

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.

SOURCE Center for Business Intelligence


'/>"/>
SOURCE Center for Business Intelligence
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. YM BIOSCIENCES ANNOUNCES COMPLIANCE WITH AIM RULE 26
3. Emisphere Technologies, Inc. Announces Pricing of Registered Direct Offering
4. BioLife Solutions Announces Exclusive CryoStor(TM) Supply Agreement With the New England Cryogenic Center, Inc.
5. Carrington Announces Nasdaq Communication; Prepares for Shares to Be Quoted on the OTC Bulletin Board and Pink Sheets
6. China Kangtai Cactus Biotech Files 2nd Quarter 2007 10QSB and Announces Unaudited Quarterly Results
7. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
8. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
9. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
10. Angiotech announces additional diameters of sutures to further expand its Quill(TM) SRS PDO product line
11. CNS Response Announces Fiscal Third Quarter 2007 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... , ... June 27, 2016 , ... ... bring innovative medical technologies, services and solutions to the healthcare market. The company's ... of various distribution, manufacturing, sales and marketing strategies that are necessary to help ...
(Date:6/27/2016)... 2016  Liquid Biotech USA ... a Sponsored Research Agreement with The University of ... from cancer patients.  The funding will be used ... with clinical outcomes in cancer patients undergoing a ... be employed to support the design of a ...
(Date:6/24/2016)... on a range of subjects including policies, debt and investment ... Speaking at a lecture to the Canadian Economics ... the country,s inflation target, which is set by both the ... "In certain areas there needs to be frequent ... not sit down and address strategy together?" He ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial ... Cary 5000 and the 6000i models are higher end machines that use the more ... the spectrophotometer’s light beam from the bottom of the cuvette holder. , FireflySci ...
Breaking Biology Technology:
(Date:5/12/2016)... 2016 WearablesResearch.com , a brand of ... results from the Q1 wave of its quarterly wearables ... consumers, receptivity to a program where they would receive ... insurance company. "We were surprised to see ... Michael LaColla , CEO of Troubadour Research, "primarily because ...
(Date:4/28/2016)... , April 28, 2016 Infosys ... (NYSE: INFY ), and Samsung SDS, a global ... that will provide end customers with a more secure, fast ...      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ) , ... but it also plays a fundamental part in enabling and ...
(Date:4/26/2016)... -- Research and Markets has announced the ...  report to their offering.  , ,     (Logo: ... forecast the global multimodal biometrics market to grow ... 2016-2020.  Multimodal biometrics is being implemented ... healthcare, BFSI, transportation, automotive, and government for controlling ...
Breaking Biology News(10 mins):