Selecting outstanding sites is the key in running a well-controlled clinical trial. Failure to identify outstanding sites could result in added costs and could lead to delays in bringing much ...
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In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. ...
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This post is sponsored by IMARC Research, Inc.Per federal regulations, 100 percent of investigative products must be accounted for at all times so they are not used for an incorrect ...
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This post is sponsored by IMARC Research, Inc.For all clinical trials, operating in compliance with the federal regulations, the agreements, the investigational plan, and the requirements of the IRB is ...
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This post is sponsored by IMARC Research, Inc.The regulations surrounding clinical trials can be difficult to understand and interpret, even for monitors well-versed in the parts of the Code of ...
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This post is sponsored by IMARC Research, Inc.The key players in a clinical investigation are infamously made up of Sponsors, monitors, investigative sites, and patients. A fundamental part of the ...
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This post is sponsored by IMARC Research, Inc.Compliance with the Federal Regulations, Agreements with the Sponsor, Investigational Plan, and Requirements of the IRB play a vital role in the FDA ...
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This post is sponsored by IMARC Research, Inc.Without a good working knowledge of Good Documentation Practices in clinical research, unintended consequences may occur. When it comes time for an inspection, ...
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This post is sponsored by IMARC Research, Inc.Since the August 2011 release of the draft guidance document by the FDA on a risk-based approach to monitoring, there has been a ...
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This post is sponsored by IMARC Research, Inc.“You do a really good job with complex trials.”We’re lucky to say that we’ve heard this from several clients over the years. But, ...
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This post is sponsored by IMARC Research, Inc.Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.” Although the ...
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This post is sponsored by IMARC Research, Inc.As a medical device focused CRO, we are often asked the difference between the investigational drug and medical device clinical research process. We ...
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This post is sponsored by IMARC Research Inc.To monitor is more than a title. It is a mindset.While procedures, checklists, guidance documents, report templates and all sorts of other things ...
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This post is sponsored by IMARC Research, Inc.Our popular Top 10 list of FDA warning letter findings is back! To assemble the list, IMARC’s clinical monitoring team reviewed warning letters ...
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The roles that documentation serves in clinical research are to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical ...
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