Risk-Based Monitoring Archives - Medical Design Sourcing

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eClinical’s Industry Outlook 2024 report highlights a significant acceleration in AI/ML adoption for clinical trials. Over half of professionals (53%) in functions like clinical operations, data management, and biometrics now see these technologies as central to streamlining trials by 2024, surpassing the emphasis on automation that dominated last year. Despite this hype cycle, a core lesson emerges: progress will be uneven as we learn to harness this new form of “magic.”

The sorcerer’s apprentice: Enthusiasm and the need for mastery

Much like the eager apprentice in Disney’s animated film “Fantasia,” which itself is inspired by Goethe’s “Der Zauberlehrling”(“Sorcerer’s Apprentice“), many in the clinical research field seem eager to unleash the power of AI even before fully grasping the strategic investment required for mastery…

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As a growing number of emerging biopharma companies seek to develop novel treatments for chronic diseases, the clinical trials market could be worth $78.3 billion by 2030.

Clinical trials, however, continue to be difficult and expensive to manage. Yet successful clinical trials, however, remain critical for investors. Small biopharmas are thus looking for guidance in navigating clinical trial design to limit risk and bolster their chance of success.

To help identify what emerging biopharma companies need to know to keep in mind when planning clinical trials, we reached out to two experts at IQVIA. Adrian Kizewski is an associate director of RBQM, digital trial management suite at IQVIA, while Gayle Hamilton is a director in the same division at the company.

What is the difference between Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM)?

Risk-Based Monitoring

Survey: Wielding AI magic in clinical trials requires a master’s touch

What biopharmas should know about RBM and RBQM