CMIC Co., Ltd., a contract research organization (CRO) jointly owned by Blackstone and CMIC HOLDINGS Co. Ltd.,  announced a strategic partnership with Bluenote, a leading agentic AI platform for life sciences that streamlines 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.

As one of the largest CROs in Japan with more than 30 years of experience, CMIC supports global pharmaceutical and emerging biopharma companies across APAC and worldwide. Through this partnership, CMIC will integrate Bluenote's AI agents across end-to-end clinical development workflows, moving beyond standalone AI tools. CMIC expects this will accelerate select regulatory and clinical documentation processes by up to 75%.

"AI has the potential to fundamentally reshape pharmaceutical development at a time when the role of CROs is rapidly evolving," said Shunji Katayama, Representative Director & President of CMIC Co., Ltd. "CROs are increasingly expected to operate as technology-driven partners, and AI is central to CMIC's long-term transformation. We are honored 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 programs are executed and accelerate the delivery of innovative therapies to patients in Japan and around the world."

"CMIC is setting a new standard for clinical operations," said Fatima Sabar, CEO & Founder of Bluenote. "They built the CRO industry in Japan, and now they are among the first to deploy agentic AI at scale. We're proud to partner with CMIC to help transform how clinical development is delivered worldwide."