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SAS Institute Risk-Based Monitoring & Fraud Detection in Clinical Trials using JMP & SAS
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Discover the transformative power of "Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS." This essential guide is designed to improve efficiency and reduce costs in clinical trials through centralized monitoring techniques. Ideal for professionals in the pharmaceutical industry, this book provides practical methodologies that enhance data quality and safety during clinical development.
This book focuses on the application of risk-based monitoring (RBM) utilizing JMP and SAS software. It addresses the challenges of traditional on-site monitoring, which can be both time-consuming and costly, often consuming up to one-third of a trial's budget. With an emphasis on proactive data analysis, it empowers clinical trial teams to identify potential issues early and streamline their review processes.
Key Features:- Centralized Monitoring Techniques: Learn how to implement RBM for effective oversight of clinical trial data.
- Comprehensive Analyses: Incorporate recommendations from TransCelerate Biopharm Inc. for enhanced data integrity.
- Fraud Detection Methods: Utilize innovative techniques to identify potential patient or investigator misconduct.
- Visual and Analytical Tools: Explore novel methods for data visualization that facilitate informed decision-making.
- Regulatory Compliance: Stay updated with recent guidance documents on risk-based approaches to clinical trials.
- Accessible to All Team Members: Designed for a diverse audience including clinicians, statisticians, and data managers.
- Part of SAS Press Program: Join the community of professionals benefiting from SAS Institute's trusted resources.
This book is an invaluable resource for clinical trial teams looking to enhance their monitoring processes. By adopting the strategies outlined in "Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS," organizations can take a proactive approach to data quality, ensuring the safety of trial participants and the integrity of results. Whether you are a clinician, statistician, or data manager, this guide will help you streamline your reviews and improve the overall quality of your clinical trials.
⚠️ WARNING (California Proposition 65):
This product may contain chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm.
For more information, please visit www.P65Warnings.ca.gov.
- Q: What is the page count of this book? A: This book contains two hundred sixty-eight pages. It provides detailed methodologies for risk-based monitoring in clinical trials.
- Q: What are the dimensions of the book? A: The book measures seven point five two inches in length, zero point six one inches in width, and nine point two five inches in height.
- Q: What type of binding does this book have? A: This book is available in paperback binding. This makes it flexible and easy to handle for practical use.
- Q: How can I apply the methodologies described in the book? A: You can apply the methodologies through JMP Clinical software. It guides users in centralizing monitoring techniques for clinical trials.
- Q: Is this book suitable for beginners? A: This book is focused on intermediate users. It assumes some prior knowledge of clinical trials and JMP methodologies.
- Q: Who is the intended audience for this book? A: The intended audience includes clinicians, statisticians, data managers, programmers, regulatory associates, and monitors.
- Q: How should I store this book? A: Store this book in a cool, dry place to avoid damage. Keeping it upright on a shelf will help maintain its shape.
- Q: Can this book help improve the quality of clinical trials? A: Yes, this book provides analytical methods to enhance data quality and safety reviews in clinical trials.
- Q: Are there any safety considerations while using the methods from this book? A: Yes, the methodologies focus on safety and quality in clinical trials. They help identify potential misconduct and enhance participant safety.
- Q: What if the book arrives damaged? A: If the book arrives damaged, you should contact the seller for their return or exchange policy. Most sellers will arrange a replacement.
- Q: Is there a warranty for this book? A: Typically, books do not come with a warranty. However, check the seller's policies for any guarantees.
- Q: What are the key features of the methodologies in this book? A: The book features risk-based monitoring techniques, fraud detection methods, and visual analytical techniques for clinical trial data.
- Q: Does this book discuss regulatory guidance on clinical trials? A: Yes, it highlights recent regulatory guidance documents on risk-based approaches for clinical trials.
- Q: How can this book help streamline clinical trial reviews? A: This book provides practical analyses and examples that help clinical trial teams streamline their review processes.
- Q: Is the author experienced in this field? A: Yes, the author Richard C. Zink is knowledgeable in clinical trials and the application of JMP methodologies.
- Q: What is the primary focus of this book? A: The primary focus is on improving efficiency and reducing costs in clinical trials through centralized monitoring techniques.