Artificial intelligence (AI) is being adopted by clinical trial sponsors, clinical research organizations (CROs) and site management organizations (SMOs) to drive efficiency. This includes protocol development, site identification, patient recruitment, patient engagement, study monitoring, and study closeout/data review. AI-enhanced data analysis is also a catalyst to the emergence of virtual trials and biosimulation. AI enablement is not without its regulatory and legislative challenges. Access to patient data is highly regulated by privacy, security, and confidentiality rules. In addition, both state and federal legislators have taken interest in regulating AI. Herein we detail leading and emerging applications of AI in the clinical research space, and delineate regulatory and legislative trends shaping the industry.

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