Indegene Launches NEXT Medical Writing Automation to Streamline Complex Medical Writing Workflows with GenAI

Medical writing teams are under constant pressure to deliver precise, regulatory-ready documents within tight timelines, often while navigating fragmented data and evolving compliance needs. NEXT Medical Writing Automation addresses these challenges head-on. It combines Indegene’s decades of domain knowledge with the power of its AI engine, Cortex. As a life sciences-specialist knowledge engineering and multi-agent orchestration platform, Cortex by Indegene enables life sciences leaders to adopt and scale this transformative technology with enterprise-grade governance.

Purpose-built by experienced medical writers, NEXT Medical Writing Automation operates within familiar environments like Microsoft Word, auto-generating compliant drafts that adapt to diverse sponsor formats and workflows. It integrates seamlessly with Regulatory Information Management (RIM) systems, maintaining traceability and consistency across documents.

With automated scheduling, intelligent task assignments, and robust data flow integration, NEXT Medical Writing Automation helps life sciences organizations scale operations efficiently while maintaining a strong compliance backbone. As document requirements grow and scrutiny intensifies, such solutions become essential to sustaining operational excellence. “We see this platform as more than automation—it’s about elevating the entire practice of medical writing,” said Sameer Lal, SVP, Enterprise Medical Solutions, Indegene. “Writers can now focus on strategic tasks and critical thinking, while the platform manages the heavy lift of data and formatting.”

The launch of NEXT Medical Writing Automation is consistent with Indegene’s ongoing commitment to advancing medical writing capabilities. It also builds on Indegene’s strategic growth, following the acquisition of Trilogy Writing & Consulting GmbH (Trilogy) last year, a global provider of specialty medical writing services across clinical, regulatory, safety, and medical content. Together, these strengthen Indegene’s ability to support market authorization applications and deliver comprehensive medical writing solutions worldwide.