Press

Buzzreach Inc. (Head office: Minato-ku, Tokyo; CEO: Takateru Inokawa) has launched a project management support service that can be implemented even under limited budgets and human resources, as part of an effort to revitalize clinical research and investigator-initiated clinical trials in Japan.

This service is based on our clinical trial and clinical research support platform ” StudyWorks® ” and provides a support system that includes case collection support from recruitment managers in collaboration with partner medical institutions, project management support from clinical research coordinators, research design consultations and DCT (decentralized clinical trial) design support from industry specialists, and strengthening collaboration between industry, academia, government, and patients by leveraging regional collaboration.

For more information on the service, please visit: 
https://buzzreach-cr-pms.studio.site/

Press release here

Background: National policy to “strengthen drug discovery capabilities” and develop a clinical research system

In its policy document for 2025, the Ministry of Health, Labour and Welfare clearly states that the establishment of an international-standard clinical research system is a pillar of strengthening drug discovery capabilities. The ministry is also considering system design and legislation to accommodate new testing methods such as the introduction of AI and decentralized clinical trials (DCT). (See: ” 2025 Summary of Future Directions for Promoting Clinical Trials and Clinical Trials” by the Clinical Research Committee of the Health and Science Council. )

On the other hand, at medical institutions, especially university hospitals and research institutes,

• Lack of research support system
• Complexity of regulatory compliance (Specified Clinical Research Act, GCP, etc.)
• Lack of research funds
• Shortage of specialists such as CRCs and data managers

Structural issues such as the above still exist. In particular, in designated clinical research and investigator-initiated clinical trials, it is difficult to ensure a sufficient operational system like that of pharmaceutical company-initiated clinical trials, and in many cases the burden is concentrated on individual researchers.

Service Overview

This service is designed around the following three pillars: “shortage of human resources,” “unified management of multi-institutional collaborative research,” and “improving case accumulation.”

Provision of business management infrastructure by StudyWorks®	– Research progress management , multi-center progress management, document management, communication between stakeholders, subject recruitment, progress visualization, etc. are all centrally managed on the cloud.
Case accumulation support by recruitment managers	・Improve the speed of case registration through collaboration with local medical institutions (utilizing partner sites)
Project management support by clinical research coordinators	・Schedule management and monitoring support for auxiliary research secretariat
Design support from industry specialists	・Research design consultation ・DCT design support ・Digital tool implementation design ・Patient-centric design

Expected effects

Shortening the case registration period
Reducing the burden on researchers
Increasing the number of research studies conducted
Creating non-medical revenue opportunities for medical institutions

Comment from Representative Director and CEO Takateru Inokawa:

Japan’s designated clinical research and investigator-initiated clinical trials are an important foundation for supporting the development of innovative medical technologies and rare disease treatments. However, a structure that relies on the efforts of individual researchers cannot be considered sustainable.

Buzzreach aims to raise the bar on Japan’s research capabilities and bring new treatment options to patients more quickly through an “implementable support model” that combines technology and specialized human resources.

Future developments

• Strengthening comprehensive collaboration with university hospitals and core hospitals
• Expanding the network of local medical institutions (partner sites)
• Strengthening collaboration between industry, government, academia and patients
• Expanded functionality for DCT (Distributed Clinical Trials)

Buzzreach will promote the creation of a sustainable infrastructure for clinical research and investigator-led clinical trials by building a Japanese version of the DCT ecosystem.

Press release here