RiskBased Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS,Used

RiskBased Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS,Used

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Improve efficiency while reducing costs in clinical trials with centralized monitoring techniques using JMP and SAS.International guidelines recommend that clinical trial data should be actively reviewed or monitored; the wellbeing of trial participants and the validity and integrity of the final analysis results are at stake. Traditional interpretation of this guidance for pharmaceutical trials has led to extensive onsite monitoring, including 100% source data verification. Onsite review is time consuming, expensive (estimated at up to a third of the cost of a clinical trial), prone to error, and limited in its ability to provide insight for data trends across time, patients, and clinical sites. In contrast, riskbased monitoring (RBM) makes use of central computerized review of clinical trial data and site metrics to determine if and when clinical sites should receive more extensive quality review or intervention.RiskBased Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS presents a practical implementation of methodologies within JMP Clinical for the centralized monitoring of clinical trials. Focused on intermediate users, this book describes analyses for RBM that incorporate and extend the recommendations of TransCelerate Biopharm Inc., methods to detect potential patientor investigator misconduct, snapshot comparisons to more easily identify new or modified data, and other novel visual and analytical techniques to enhance safety and quality reviews. Further discussion highlights recent regulatory guidance documents on riskbased approaches, addresses the requirements for CDISC data, and describes methods to supplement analyses with data captured external to the study database.Given the interactive, dynamic, and graphical nature of JMP Clinical, any individual from the clinical trial team including clinicians, statisticians, data managers, programmers, regulatory associates, and monitors can make use of this book and the numerous examples contained within to streamline, accelerate, and enrich their reviews of clinical trial data.The analytical methods described in RiskBased Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS enable the clinical trial team to take a proactive approach to data quality and safety to streamline clinical development activities and address shortcomings while the study is ongoing.This book is part of the SAS Press Program.

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Shipping
We ship your order within 2–3 business days for USA deliveries and 5–8 business days for international shipments. Once your package has been dispatched from our warehouse, you'll receive an email confirmation with a tracking number, allowing you to track the status of your delivery.

Returns
To facilitate a smooth return process, a Return Authorization (RA) Number is required for all returns. Returns without a valid RA number will be declined and may incur additional fees. You can request an RA number within 15 days of the original delivery date. For more details, please refer to our Return & Refund Policy page.

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Warranty

We provide a 2-year limited warranty, from the date of purchase for all our products.

If you believe you have received a defective product, or are experiencing any problems with your product, please contact us.

This warranty strictly does not cover damages that arose from negligence, misuse, wear and tear, or not in accordance with product instructions (dropping the product, etc.).

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