Key Points Of FDA's Quality Management Maturity Program, Tips For Preventing Clinical Trial Fraud, and More
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Welcome to the Clinical Trial Insights newsletter, featuring strategic insights and expert opinions on designing and running clinical trials. Each edition covers the latest trending articles on?ClinicalLeader.com.
In this week's issue, we'll review the FDA's Quality Management Maturity Program, how to design a clinical trial protocol with patient and FDA collaboration, tips for preventing clinical trial fraud, the benefits of eConsent, and other popular insights.
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TOP 5 READS OF THE PAST WEEK
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance. In this article, Peter Calcott of calcott consulting reviews key points of the program.
On a recent episode of Clinical Leader Live!, hosted by Life Science Leader Chief Editor Ben Comer, clinical trial experts Mitchell Katz, Ph.D., SVP, global clinical operations at Kyowa Kirin, Inc.- U.S.; Jessica Powell, VP, clinical operations at Alto Neuroscience; and Michael Krams, chief quantitative medicine officer at Exscientia, sat down to discuss the quintessential do’s and don’ts of modern clinical trials.
Clinical trial fraud is an all too common problem that affects the integrity of scientific and medical advancement. There will always be bad actors, but there are various things that sponsors can do to identify potential issues and subsequently build trust in research. Harbor Clinical shares several strategies for upholding due diligence and substantially reducing the risk of fraud in clinical trials.
领英推荐
“Research” is usually part of a physician's education, but clinical research is not. Yet, sponsors typically want physicians with clinical trial experience when looking for principal investigators (PIs).To help develop the next gen of PIs, Lauren Ballina Chang of Clinical Research Fastrack shares five best practices for building up the best PIs in the industry.
An electronic informed consent (eConsent) solution provides multiple benefits to patients, caregivers, and clinical trial staff. Yet several barriers still prevent widespread adoption. IQVIA Technologies takes us on a deep dive into the data substantiating experiences with electronic informed consent to better understand their positive impact on the outcomes of clinical trials.
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