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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



2010 Conference Explores the eCTD



February 17, 2010 | eCliniqua, along with CHI and Bio-IT World, is hosting the inaugural eCTD 2010 conference at the Crowne Plaza Philadelphia Downtown on March 10, 2010.

The conference will be co-located with the Summit for Clinical Ops Executives (SCOPE), a four-day cluster of events taking place March 8-11, 2010.

The electronic Common Technical Document (eCTD) was introduced two years ago and promises to streamline the submissions process. (See, "The eCTD--a Six-Month Checkup") To date, over 30,000 eCTD sequences have been submitted to the FDA. But there are still challenges to adoption and implementation.

The eCTD 2010 conference will explore tips for achieving efficiency and compliance in electronic submissions.The day-long even will feature presentations on: 

  • How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submission
  • Global Submission Management from Concept to Realization
  • Taking eCTDs off the Critical Path to Drug Development
  • Electronic Signatures & Regulatory Processes, What Agencies are Saying

View conference details and register today at www.clinicalops.com/ctd. Mention key code ECL & save $300 off your registration.

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