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Navigating the Clinical Trial Process
In this video, we begin to explore why a clinical trial may be required and how to navigate through the clinical trial process. This video focuses on FDA regulations. Future videos delve into the clinical trial process as regulated by Health Canada, the Medicines and Healthcare products Regulatory Agency, and the relevant regulations in EU and EEA countries. This video sets the stage for our next segment on the products liability implications of clinical trials.
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Products Liability
This video begins with a quick overview of products liability law as it applies to the life sciences industry then a discussion of how products liability may become an issue for those running clinical trials, and lastly, what you can do to reduce your exposure to liability.
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The Informed Consent Process
Part three, we review the informed consent process. If you are ready to start phase one of your clinical trial, you might begin with subject recruitment through advertising. Once you have a group of individuals who are interested in participating in your clinical trial, this is where the informed consent process begins.
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Clinical Trial Agreement
This video discusses the importance of the clinical trial agreement (CTA), which is essential for outlining the roles, responsibilities, and obligations of all parties involved to ensure regulatory compliance and patient safety.
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Vetting Your Institutional Review Board (IRB)
Part 5 of this clinical trial series focused on the critical topic of vetting your Institutional Review Board or IRB. Ensuring your IRB is appropriately qualified and prepared is essential for mitigating risks in your clinical trials. This video will cover questions like: What is an IRB? Why is IRB oversight crucial for clinical trials? And how can you vet your IRB to ensure compliance with regulatory requirements?
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Comparing Clinical Trials in the UK vs. the US
In Part 6 of the this series, we’ll be taking a closer look at how the UK clinical trial approval process differs from that of the FDA here in the United States. Our goal is to help US-based clinical trial sponsors better understand what to expect if they’re considering running a trial in the UK—whether that’s to support FDA approval, to enter the UK market, or as part of a broader global strategy.
