Clarivate Unveils Agentic AI to Streamline Life Sciences Regulatory Safety Workflows

Clarivate has launched an agentic artificial intelligence assistant designed to help life sciences companies manage regulatory compliance and safety workflows more efficiently. The new capability applies autonomous, task-oriented AI capabilities to repetitive regulatory tasks — from case intake and triage to standardized report generation and audit trail creation — with the goal of reducing manual review time and improving consistency across global operations.

The assistant is aimed at pharmacovigilance, drug safety and broader regulatory teams that face growing volumes of adverse-event data and increasingly complex cross-border reporting requirements. By automating routine steps and surfacing prioritized work items, agentic AI can help teams focus on escalations and judgment calls that require human expertise. Clarivate positions the tool as a complement to existing safety systems and databases rather than a replacement, enabling integration into established workflows and recordkeeping systems.

Key benefits highlighted include faster case processing, more uniform application of regulatory rules, and improved traceability for audits and inspections. For multinational programs, the assistant can help reconcile differing regional submission formats and accelerate preparation of regulatory filings. In practice, that means potentially shorter cycle times for safety assessments and regulatory reporting, and clearer documentation to support compliance with authorities such as the FDA and EMA.

Clarivate’s announcement arrives as life sciences companies contend with rising data volumes from clinical trials, real-world evidence, and post-market monitoring. Industry leaders have increasingly turned to machine learning, natural language processing and automation to extract structured insights from unstructured reports, spot safety signals earlier, and maintain regulatory readiness.

While agentic AI promises efficiency gains, successful deployment typically depends on careful validation, strong governance and human oversight to ensure accuracy and regulatory defensibility. Organizations adopting these tools will need to define roles, escalation protocols and quality controls so that automated outputs are auditable and consistent with company policies.

Overall, Clarivate’s agentic AI assistant underscores a broader shift in life sciences operations toward intelligent automation, where AI accelerates routine regulatory work while leaving strategic and clinical judgment to human experts. The move may help companies reduce administrative burden and speed safety-related decision-making as regulatory expectations and data flows continue to evolve.