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Consultants Corner

Current Issue: November 2008


Electronic Data Capture in Clinical Trials: Four Factors for Success
Cyndee Woelfle, Promedica International

Real-time data access and automated edit checks are just two of the many benefits that EDC can bring to clinical trial management.

Q&A: FDA and ISO Guidance

Guidance for device makers who voluntarily submit ISO audit reports has been delayed by FDA until the end of this year. Will the agency make its new deadline? We asked Nicolaas C. Besseling, principal, BesTech Consulting Services, about that and some related matters.

 
 

Consultants Corner Archives

Fall 2008
  • Chapter and Verse on SOPs
    Take a commonsense approach: writing overly restrictive SOPs can lead your company into trouble.
  • Q&A: Regulatory Reform in Japan: Is It Change We Can Believe In?
    Ames Gross, president and founder of Pacific Bridge Medical, has helped more than 200 medical device companies navigate the often-tortuous business and regulatory practices of countries in the Asia/Pacific region. In this Q&A, he offers some insights on Japan’s regulatory approval process.
Summer 2008
Spring 2008
Winter 2008