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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 Tue, Mar 27, 2018

What Makes A Well Controlled Clinical Trial?

A well-controlled clinical trial is much like a well controlled experiment. They are both rooted in the cornerstone of the scientific method. What exactly is a clinical trial? According to clinicaltrials.gov, “In a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, for example, diet.” In the 21 CFR 314.126, the FDA lays out regulations as to what makes an “Adequate and Well-Controlled study” as one that has:

Topics: Well-Controlled Clinical Study, clinicaltrials.gov

Posted by Sandra Maddock on Mon, Jul 09, 2018

Conducting a Well-Controlled Clinical Study When Clinical Data is Required

There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

Topics: Clinical Data, Well-Controlled Clinical Study, FDA, 510(k)