data management

Best Practices for Designing Study Quality Metrics

Study Quality Metrics (SQM) is a clinical study oversight strategy designed to monitor trial data on a regular basis.  The goal of SQM is to ensure that study hypotheses are not compromised and to take corrective action as early as possible to enhance or improve the quality of study data, thereby ensuring that study results are valid and credible. In part one of our SQM series, Jim Young, MS, Senior Principal Statistician, shares some best practices for creating SQM.


Exploring the FDA’s Prospective Routine Observational Monitoring Program Tools (PROMPT) for Safety Surveillance

In 2007, partly due to several high profile drug safety issues, the federal government imposed the FDA Amendments Act (FDAAA). The FDAAA mandated that the FDA augment existing US drug safety systems by using large repositories of patient healthcare data to proactively monitor potential issues in marketed pharmaceutical products.


A Super Find

Most days you can find UBC employee Donna Gugger immersed in data in support of our pharmaceutical/biotech clients, their products, and patients.  As Director, Clinical Data Management, Donna and her team work on phase I-III clinical trials, phase IV postmarketing trials, Knowledge, Attitude, & Behavior Surveys (KABS), and REMS studies.  Being inquisitive and analytical are vital in her role, and, it seems, in finding an unexpected bright spot in the wake of Superstorm Sandy.

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