Tuesday, August 28, 2012

Theorem Clinical Research – “Little Advisor”

 

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When you need a condensed version of ISO 14155:2011, THINK THEOREM.

In many ways, ISO 14155:2011 is the medical device equivalent of the ICH Good Clinical Practice manual for investigational medicinal products. It's an important document packed with vital information every investigator should know in order to perform medical device trials compliant with international standards and best practices.

The ICH GCP manual is very thorough, but it isn't going to be on the NYT Best Sellers List anytime soon.

 
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We have the solution

Theorem Clinical Research has just published the Little Advisor, ISO 14155:2011 for Medical Device Trials. The Little Advisor breaks down all the key concepts into a practical, manageable size, with citations back to the original ISO document in case additional detail is required. Investigators get information and advice they can really use on all the original ISO 14155:2011 topics, including:

  • Qualifications
  • Regulatory/EC
  • Informed Consent Process
  • CIP Compliance
  • Resources
  • Training
  • Device Accountability
  • Documentation
  • Safety Reporting
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Order your copy now

Like CliffsNotes, the Little Advisor gets right to the point and tells you exactly what you need to know without needless detail. We think it should be on every principle investigator's bookshelf. The Little Advisor, ISO 14155:2011 is only $6.99 (plus shipping and handling) and it's available now. Don't think twice. Order your copy now.

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