Insight on AI – July 2026, Issue 16

Welcome to the July, Issue 16 edition of Artificial Vigilance, Essjay Solutions, Insight on AI, dedicated to helping pharmacovigilance professionals understand, engage with and adapt to the rapidly evolving world of artificial intelligence.

Innovation

Genesis Makes AI Evidence Synthesis Platform and Releases it for Free

Genesis Research Group has released its EVID AI evidence synthesis platform free of charge to eligible life sciences organisations and researchers until the end of 2026. Designed to bring evidence review into a single environment, the platform aims to reduce the time teams spend manually searching, screening and monitoring scientific literature.

Developed by Genesis scientists and refined through two years of use on client projects, EVID AI supports rapid evidence searches, targeted literature reviews, ongoing surveillance and full systematic reviews. The platform has been designed around workflows in health economics and outcomes research, real-world evidence, medical affairs and market access.

AI-assisted evidence synthesis could allow specialists to spend less time finding information and more time interpreting it, particularly in pharmacovigilance and other evidence-intensive functions. However, poorly designed searches or missed studies could introduce bias, meaning human oversight, validation and transparency remain essential to maintaining scientific integrity.

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Industry News

MethodHub and Datafoundry Join Forces to Integrate AI with Pharmacovigilance

MethodHub Software and Datafoundry have formed a strategic partnership aimed at delivering AI-powered pharmacovigilance solutions to pharmaceutical, biotechnology and life sciences organisations. The collaboration combines MethodHub’s expertise in PV operations, regulatory compliance and global service delivery with Datafoundry’s specialist AI technology for drug safety.

The technology includes Safety AI for end-to-end case management, Signal AI for signal detection and false-positive reduction, and multilingual AI-powered literature monitoring. Together, the companies aim to help organisations replace fragmented manual processes with more connected and automated safety workflows while maintaining compliance with expectations from regulators including the FDA and EMA.

The partnership reflects a wider shift towards AI implementation as an ecosystem rather than a standalone software purchase. As adverse event volumes and regulatory complexity increase, combining validated technology with experienced PV professionals, governance frameworks and regulatory expertise could help teams automate repetitive work while focusing more attention on higher-value scientific and clinical priorities.

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Regulation News

EMRN’s AI Workplan Celebrates its 3rd Birthday: Here’s How it Evolved

Three years after the European Medicines Regulatory Network began formalising its approach to AI, its workplan has progressed from exploring potential applications to creating practical regulatory structures for responsible adoption across the medicines lifecycle. Developed through the HMA-EMA Big Data Steering Group, the initiative aims to support productivity, automation, improved data insights and stronger regulatory decision-making.

The network has since developed internal AI expertise, guiding principles for large language models and an AI Observatory for horizon scanning, while translating its experience into practical guidance for regulators and industry. Its coordinated structure also helps establish more consistent expectations across European national competent authorities.

International cooperation is becoming increasingly important too, with the EMA and FDA publishing joint Good AI Practice principles for drug development. As the workplan enters its fourth year, the emphasis is moving towards governance, guidance and collaboration that can provide organisations with greater clarity and regulatory predictability when adopting AI.

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AI News

The Year of the AI Agent, and the Reckoning to Come

Agentic AI is rapidly becoming one of the technology industry’s biggest areas of investment, with nearly three-quarters of companies expected to deploy AI agents within two years. Yet governance is struggling to keep pace, with only 21% of organisations reporting mature frameworks for controlling what autonomous systems are allowed to do.

Questions are also emerging around whether current enthusiasm matches genuine business value. Gartner predicts that more than 40% of agentic AI projects could be cancelled by the end of 2027 because of rising costs, unclear returns and inadequate risk controls, while warning that many vendors are simply “agent washing” existing automation technologies.

For highly regulated industries such as pharmacovigilance, the opportunity may lie in introducing autonomy gradually. As increasingly capable and affordable AI systems emerge, organisations that combine automation with close supervision, clear controls and human accountability are likely to be best positioned to benefit.

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