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Fourth Annual Auditing Forum Scheduled
07.19.2010
Oct. 2010 Orlando, Expert Techniques, Panel Discussions and Case Studies Presented
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Norton Audits Adds Monitoring Audits to Services
05.14.2010
Monitoring Report Reviews and On-Site Monitor Audits Completed for First Clients
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Consulting – Expert Advisement and Services


Whether you are a Clinical Investigator, Sponsor, CRO, IRB or other Clinical Research Organization, our independent expertise combined with direct experience in regulatory agencies and hundreds of organizations like yours allow us to provide project-based and advisement services to assist you in achieving your goals.

Our Consulting Experience and Offering Includes, but is not limited to:
  • Mock FDA Inspections
  • Site Qualifications
  • Organization Risk Assessments
  • Study Budget Preparation
  • Protocol and Associated Forms Development
  • Policy and Standard Operating Procedure (SOP) Development
  • Assisting Clinical Investigators in the process of Obtaining Clinical Trials
  • Preparing for or Responding to FDA and Sponsor Inspections and Audits
  • FDA Submission Preparation, Including:
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • Pre-Market Application (PMA)
    • Medical Device 510(k)
    • Post-Market Surveillance Activities
For more information or to request our Services, please contact us.
 
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