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Posted by John Lehmann on Tue, Jul 12, 2016

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: Risk Management, FDA, Clinical Research

Posted by John Lehmann on Mon, Aug 10, 2015

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within a clinical trial. To achieve this, the sponsor must invest resources into these different aspects of a clinical trial. One specific aspect of integrating quality involves how risks are approached and managed throughout the course of a study. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released documents in 2013 focused on the integration of traditionally development and manufacturing quality principles, including risk-based approaches into the clinical research industry. FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials” both describe how regulators now expect a quality, risk-based approach when conducting clinical research. These documents are examples of the shift toward quality techniques underway within industry when developing, initiating, and executing studies.

Topics: Risk Management, IMARC Whitepaper, FDA

Posted by John Lehmann on Fri, Jun 05, 2015

Risk Management Whitepaper

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: FDA Guidance, Risk Management, IMARC Research Whitepaper

Posted by John Lehmann on Wed, Mar 04, 2015

Risk Management in Clinical Research

Please take time to review 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: Risk Management, Emily Haglund, GxP Lifeline, Clinical Research

Posted by John Lehmann on Wed, Mar 04, 2015

Risk Management in Clinical Research

As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a new whitepaper that discusses the principles of risk management and their application to clinical research.

Topics: Whitepaper, Risk Management, Guidance Document, IMARC Research, FDA

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Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.