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:1/19/2017)... Ky. and HOUSTON ... Inc. ("NX Prenatal") today announced the formation of ... together leading clinicians and industry veterans who enhance ... company as it accelerates development of its novel ... to provide medical, clinical and strategic guidance for ...
(Date:1/19/2017)... (PRWEB) , ... January 19, 2017 , ... ... of product vigilance software to leading biopharmaceutical and medical device manufacturers and regulators, ... a fully 21 CFR Part 11-compliant email client designed to provide product vigilance ...
(Date:1/19/2017)... ... 18, 2017 , ... The American Medical Informatics Association (AMIA) ... Sharing Policy. Specifically, the nation’s leading informatics experts, said data sharing plans should ... AMIA recommended that NIH earmark funding for researchers to produce and execute data ...
(Date:1/19/2017)... NEW YORK , Jan. 18, 2017 /PRNewswire/ ... expected to reach USD 92.9 billion by 2025, ... Research, Inc. Pharmaceutical industry has been adaptive of ... functions as early as 2002. Among the services ... the forerunners. For instance, Johnson & Johnson was ...
Breaking Biology Technology:
(Date:12/16/2016)... 16, 2016 The global wearable medical device market, in ... 2021 from USD 5.31 billion in 2016, at a CAGR of ... ... technological advancements in medical devices, launch of a growing number of ... connectivity among healthcare providers, and increasing focus on physical fitness. ...
(Date:12/15/2016)... Mich. , Dec. 15, 2016  There is ... car doors or starting the engine. Continental will demonstrate ... Las Vegas . Through the combination ... Start and Entry) and biometric elements, the international technology ... of vehicle personalization and authentication. "The integration ...
(Date:12/7/2016)... to a new market research report "Emotion Detection and Recognition Market by Technology ... End User, And Region - Global Forecast to 2021", published by MarketsandMarkets, the ... USD 36.07 Billion by 2021, at a Compound Annual Growth Rate (CAGR) of ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):