Medical Device CRO Blog

Posted by John Lehmann on Tue, Dec 08, 2015

Using Risk Management in Clinical Research

Please take time to view Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline. The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.

Topics: ISO 14155, Risk Management, GxP Lifeline

Posted by John Lehmann on Wed, Mar 04, 2015

Understanding the Difference Between FDA Regulations and ISO 14155

As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155. IMARC Research has created a new whitepaper that highlights these differences.

Topics: Federal Regulations, ISO 14155, CFR 21, IMARC Research Whitepaper

Posted by Kelly Schindelholz on Wed, Mar 04, 2015

What Do I Do When Source is Incorrect?

In general, most hospitals and clinics use electronic medical records (EMR), or a mix of electronic and paper medical records. Often paper records are scanned into the EMR in order to house all records for a particular patient in one location.

Topics: ISO 14155, Electronic Medical Records, Source Documentation, Clinical Monitoring

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Understanding the Difference Between FDA Regulations and ISO 14155

What Do I Do When Source is Incorrect?

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