FDA Compliance Office Wants To Find Clinical Trial Problems In Time To Correct Them
The agency is seeking a quality-by-design approach to clinical trials so sponsors can identify potential risks to patient safety and trial implementation up-front and take steps to avoid them.
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Agency yields to some, denies other industry requests in final guidance that declines to lay out one prescriptive monitoring path.
Recent Duke University survey found that firms predominately conduct frequent visits to each clinical investigator site but "the rationale behind any specific monitoring approach does not appear to be evidence-based."
Output from the Clinical Trials Transformation Initiative, whose executive board was named May 5, is expected to lead to new FDA clinical trial guidance