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Originally Published MX September/October 2006

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Managing Clinical Trials

The team selected to conduct a clinical trial for a device manufacturer should include personnel with expertise in regulatory affairs and clinical trial management. When identifying skills and resources required for a successful trial, medtech executives should consider the following.

  • Clinical trial monitors need to be properly qualified and trained. Expecting sales
         representatives to monitor a clinical trial is a high-risk strategy.
  • One clinical trial monitor can properly manage about 8 to 12 sites per year, depending on the
         complexity of the trial. If there are 30 sites in a trial, at least three monitors will be needed.
  • Per-patient costs vary with the complexity of the trial, but are usually in the range of $1000 to
         $5000. Coronary stent and similarly complex trials may command higher per-patient fees.
  • External monitoring costs about $2000 to $3000 per site visit, depending on the complexity
         of the trial.
  • Data management should be undertaken with a database that is compliant with "Electronic
         Records; Electronic Signatures" (21 CFR 11), the FDA regulation governing electronic
         methods of maintaining and approving compliance-related records. Microsoft Excel and
         Access databases are not compliant with 21 CFR 11. The cost of data management will
         depend on the number of patients and the number of case report form pages required.

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