CMIC Collaborates With Bluenote to Accelerate Clinical Documentation by Up to 75%

• CMIC Co., Ltd., a contract research organization (CRO), has partnered with Bluenote to deploy agentic AI across clinical development operations.

• The companies say the technology could accelerate certain regulatory and clinical documentation processes by up to 75%.

CMIC Co., Ltd. has announced a strategic partnership with Bluenote to deploy agentic artificial intelligence across clinical development workflows. The collaboration aims to support biopharma sponsors in improving the speed, quality, and scalability of clinical trial operations and regulatory submissions. 

The agreement brings together CMIC, a contract research organization (CRO) jointly owned by Blackstone and CMIC HOLDINGS Co. Ltd., and Bluenote, an AI platform developer focused on life sciences documentation workflows. Under the partnership, CMIC will integrate Bluenote’s AI agents across end-to-end clinical development activities. 

Bluenote’s platform supports documentation across multiple stages of drug development, including clinical protocols, statistical analysis plans, clinical study reports, electronic common technical document (eCTD) modules, and CMC documentation. The system is designed to align with regulatory requirements set by organizations such as the International Council for Harmonisation (ICH), the U.S. Food and Drug Administration (FDA), the Pharmaceuticals and Medical Devices Agency (PMDA), and the European Medicines Agency (EMA). 

CMIC said the integration of agentic AI into its workflows is expected to accelerate certain regulatory and clinical documentation processes by up to 75%. The company has more than 30 years of experience supporting pharmaceutical and biotechnology companies across Asia-Pacific and other regions through clinical development services. 

“AI has the potential to fundamentally reshape pharmaceutical development at a time when the role of CROs is rapidly evolving.” 

Shunji Katayama, Representative Director and President of CMIC Co., Ltd.,