Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs) are important forces assisting sponsors and investigators in conducting clinical studies and are frontline workers responsible for controlling and ensuring the quality of clinical studies. With the continuous enhancement of China's technological and R&D capabilities, along with changes in regulatory policies and the environment, the pharmaceutical industry in China is accelerating its upgrade toward original innovation and internationalization. The number of domestic and international multicenter clinical studies is rapidly increasing, which places higher demands on the quality of clinical studies.

Under the new circumstances, to provide more standardized professional services for CRAs and CRCs and to ensure the execution quality on the front line of clinical studies, the Shanghai Center of Biomedicine Development commissioned the Shanghai Pharmacological Society to organize and compile two group standards—"Shanghai Specification for Capacity Evaluation of Clinical Research Associate" and "Shanghai Specification for Capacity Evaluation of Clinical Research Coordinator"—based on relevant domestic and international laws and regulations and from the perspectives of individuals, enterprises, and clinical study institutions. In accordance with the procedures for issuing group standards, after data collection, argumentation and revision, soliciting opinions, and multiple modifications and improvements, a draft for review was formed. After being reviewed and approved by the Shanghai Pharmacological Society, the above two group standards were released on March 25 and officially announced for implementation on March 29.

Under the leadership and organization of the Shanghai Center of Biomedicine Development, UnionClin had the honor to participate along with more than a dozen centers and enterprises, including the First Affiliated Hospital of Naval Medical University (Changhai Hospital), Zhongshan Hospital Fudan University, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Drug Evaluation and Inspection Center, Shanghai Pharmacological Society, and Tigermed, in jointly completing the group standard " Shanghai Specification for Capacity Evaluation of Clinical Research Associate". It is hoped that the initiative can further ensure the scientific rigor and standardization of the clinical study execution process to promote the continuous improvement of clinical study standards in the pharmaceutical industry of China.

UnionClin has established nine major professional service modules to provide sponsors with end-to-end services from strategy to implementation; and to provide clinical research centers with digital systems and dedicated CRC teams. Supported by intelligent systems and technology development, driven by PI and site requirements, centered on project progress and quality, and using a system + CRC innovative model for deep collaboration with hospitals and experts, we build a fast, efficient, high-quality, and professional digital innovative SMO for clinical research services to provide clinical operation-related services for innovative drugs in advantageous therapeutic areas and to accelerate the progress and reduce costs for new drug clinical projects.

The above content is sourced from Shanghai Center of Biomedicine Development