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

1.1 Overview

Pharmaceutical development is an extremely complex affair. Once a promising compound is identified, steps are taken to optimize the chemical properties and formulation, understand the pharmacokinetics, pharmacodynamics, and safety through animal testing, then introduce the drug into humans to identify an efficacious and safe dose that can address some unmet medical need. The process involves countless tests and experiments, identifying clinicians to recruit patients into clinical trials, communicating with vendors for supplies or analysis, and routinely contacting regulatory agencies to ensure standards are met or to disclose any safety signals. There are study data to retrieve, monitor, and prepare for analysis and submission; frequent ...