Conducting clinical research in medical device studies using a quality systems approach

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imarcMDFDA is encouraging a quality systems approach to conducting clinical trials. The Clinical Trials Transformation Initiative (CTTI) established the Quality by Design initiative for clinical research. Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks.

Well-designed randomized clinical trials are the most reliable way to get unbiased information to achieve this outcome. However, poor quality and inefficiency in clinical research can seriously limit the number of questions that can be answered about the appropriate uses of new medical products, and also significantly delay access to new therapeutic innovations.

This whitepaper addresses what utilizing a quality systems approach to clinical research means, why a quality systems approach is important and initial steps to consider taking when conducting a clinical trial using a quality systems approach.

Have you implemented a quality systems approach to conducting clinical trials?

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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