This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based monitoring (RBM) approach may be the best method to support clinical studies while keeping an eye on compliance.
Resources from this episode:
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Guidance for Industry (2013)
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A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers - Draft Guidance for Industry (2019)
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Tackling the Challenges of Transitioning to Risk-Based Monitoring
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About Our Guest:
Amanda Coogan, Senior Customer Partnership Manager, Remarque Systems
Amanda spent the first 12 years of her clinical research career in clinical operations for university hospitals and medical device firms supporting domestic and international studies. She then transitioned to the software industry, where she has served for 6 years as a consultant, subject matter expert, and project manager to small and large pharma, medical device, and CRO customers supporting their implementation of Risk-Based Quality Management. In addition to working with customers to optimize their use of technology within their RBQM strategy, she provides clinical trial operation expertise to support software product development. She can be reached at acoogan@remarquesystems.com
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