Artificial intelligence to usher in new era of drug safety automation

Genpact’s new Pharmacovigilance Artificial Intelligence solution promises to transform drug safety data management and reporting…


Genpact is investing in leading digital technologies that are transforming industries. Genpact’s Pharmacovigilance Artificial Intelligence (PVAI) will be the life sciences industry’s first fully-integrated, end-to-end adverse event (AE) processing solution, leveraging intelligent automation to not only dramatically reduce the effort of processing adverse events, but also to enable an AI-driven level of real-time predictive analytics and actionable insight not previously possible.

As life sciences companies face escalating AE volumes for their products and increasing pressure to improve quality and compliance while reducing costs, they are looking for breakthrough solutions to help them transform their pharmacovigilance operations.

Genpact’s PVAI offering brings together and integrates optical character recognition, robotic process automation, natural language processing, and machine learning technologies to automatically extract and code AE data from unstructured and semi-structured source documents – eliminating manual workflow, saving pharmaceutical companies significant time and resources, and helping to establish a scalable PV operating model. Most importantly, the solution continuously builds predictive insights as more and more AE goes through it over time.

“Industry leaders have stated that the current manually-intensive approach to AE processing is simply not sustainable and needs an innovative approach. Through robust pilot testing with clients, our new PVAI solution has proven that the vast majority of case processing can be successfully automated in a fraction of the time and cost,”

said Balkrishan Kalra, senior vice president and business leader, Consumer Goods, Retail, Life Sciences and Healthcare, Genpact.  “We continue to invest in PVAI and are excited to bring this holistic, unique and market-leading, AI-driven digital proposition to the industry.”

As part of its investments in PVAI, Genpact recently acquired the assets and team of November Research Group (NRG), a Berkeley, California-based leading provider of product vigilance software. The transaction added NRG’s domain expertise and fully-featured pharmacovigilance Software-as-a-Service, contributing to PVAI’s pioneering approach to automating drug safety operations in the life sciences industry. Terms of the deal were not disclosed.

“The November Research Group team is very excited to be part of the Genpact PVAI team and combining our deep domain expertise and our PV solutions with their AE data extraction engine, analytics, and innovative AI approach to provide a truly game-changing PV solution,” said Brad Gallien, vice president, November Research Group.  “Together, we are creating a new paradigm for drug safety.”

Genpact currently serves the majority of global life sciences companies, helping pharmaceutical and medical devices companies pursue global growth, achieve cost reduction, increase speed to market, and improve regulatory compliance by providing a range of digital solutions, analytics services, and business process transformation expertise. Genpact has a large life sciences regulatory services business stemming from its acquisition of Pharmalink in 2014.