TransCelerate reports on the results of 2019, 2020, and 2021 member company (MC) surveys on the use of intelligent automation in pharmacovigilance processes. MCs increased the number and extent of implementation of intelligent automation solutions throughout Individual Case Safety Report (ICSR) processing, especially with rule-based automations such as robotic process automation, lookups, and workflows, moving from planning to piloting to implementation over the 3 survey years. Companies remain highly interested in other technologies such as machine learning (ML) and artificial intelligence, which can deliver a human-like interpretation of data and decision making rather than just automating tasks. Intelligent automation solutions are usually used in combination with more than one technology being used simultaneously for the same ICSR process step. Challenges to implementing intelligent automation solutions include finding/having appropriate training data for ML models and the need for harmonized regulatory guidance.

AbbVie Pharmacovigilance and Patient Safety Business Process Office North Chicago IL USA

Amgen Pharmacovigilance Operations Los Angeles CA USA

Bayer AG Medical Affairs and Pharmacovigilance Pharmaceuticals Berlin Germany

Genentech A Member of the Roche Group South San Francisco CA USA

GlaxoSmithKline Global Safety Upper Providence PA USA

Merck Healthcare Case and Vendor Management Global Patient Safety Darmstadt Germany

MSD R and D IT Prague Czech Republic

Novartis Chief Medical Office and Patient Safety Novartis Global Drug Development Dublin Ireland

Trinity College Dublin Ireland

UCB IT Patient Safety Brussels Belgium

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