CMIC Co Ltd, a contract research organisation (CRO) jointly owned by US investment firm Blackstone and Japan-based CMIC HOLDINGS Co Ltd, announced on Tuesday that it has partnered with Bluenote, an agentic AI platform for life sciences designed to streamline regulatory and clinical documentation workflows.

Through this collaboration, CMIC and Bluenote will deploy agentic AI across clinical development to help biopharma sponsors enhance the speed, quality, and scalability of clinical trial operations and regulatory submissions.

Bluenote's agentic AI platform supports documentation across all development stages, including protocols, statistical analysis plans, clinical study reports, eCTD modules, and CMC documentation. It is designed to align with global regulatory requirements, including ICH, FDA, PMDA, and EMA, and provides traceability to source data, validation guardrails, and automated quality review.

Shunji Katayama, CMIC representative director and president, said: "AI has the potential to fundamentally reshape pharmaceutical development at a time when the role of CROs is rapidly evolving. CROs are increasingly expected to operate as technology-driven partners, and AI is central to CMIC's long-term transformation. We are honoured that Bluenote has selected CMIC as a major CRO partner, and by combining our deep clinical development expertise with Bluenote's advanced agentic AI technology, we aim to redefine how clinical programmes are executed and accelerate the delivery of innovative therapies to patients in Japan and around the world."