RBQM implementations fail not because the software is wrong — but because the human environment surrounding it was never engineered.
Fred Blais
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Fred Blais, RBQM Lead at CluePoints, has spent the last 13 years of his 19-year clinical trial career inside Central Statistical Monitoring and Risk-Based Quality Management. His experience has led him to a conclusion – RBQM implementation failure is caused by a lack of understanding of human behavior – not faults in the software. He discusses how design decisions based on behavioral science mirror ICH E6(R3) and what is needed to produce extraordinary outcomes.
Articles by Fred Blais
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