This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic…
- United States Food and Drug Administration (FDA): Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (August 2013)
- European Medicines Agency (EMA): Reflection Paper on Risk Based Quality Management in Clinical Trials (November 2013)
…it’s most likely here to stay.