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Compliance In Focus

remote services

LEARN MORE ABOUT REMOTE SERVICES

Keep Your Clinical Trial Moving from a Distance

You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.

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Posted by John Lehmann on Wed, Mar 04, 2015

21 CFR 312 vs. 812: What’s the Difference?

On Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials.  Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

Topics: BioEnterprise, 21 CFR 812, FAIR Shake. Training Technique, 21 CFR 312

Posted by John Lehmann on Wed, Mar 04, 2015

Four Tips on Navigating the Regulatory Environment in Europe

A MedCity News article provided four tips on how best to navigate the regulatory environment in Europe.  There is an increasing trend by medical device manufacturers to seek the European Union’s CE Mark for their initial regulatory approval.

Topics: Regulatory Environment in Europe, BioEnterprise, AxioMed, REU Associates