An Introduction to Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP® and SAS®

Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS - Chapter 1

It’s difficult to overstate the complexity of the pharmaceutical development process. Encompassing countless tests, patient recruitment and detailed safety and efficacy evaluations -- all while adhering to demanding regulatory requirements -- it’s no wonder that drugs take years to reach the market and costs continue to rise.

In particular, antiquated clinical trial monitoring practices are proving to be time consuming, expensive and prone to error. What can be done to help accelerate time to market and rein in costs, while ensuring the validity and integrity of clinical trial results?

In Chapter 1 of Risk-Based Monitoring and Fraud Detection in Clinical Trials, author Richard Zink suggests revolutionizing the clinical trial process by eliminating manual, paper-based data review methods.  He outlines interactive software-based techniques for:

  • Creating a centralized view of trial data to alert you to quality and safety issues at clinical sites.
  • Uncovering patient and investigator misconduct within the clinical trial.
  • Accelerating the review process so that reviewers don’t spend precious time on previously examined data.

 

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