The EPNextS Group's Clinical Trial Business boasts one of the most significant service delivery capabilities in Japan. We staff approximately 1,100 Clinical Research Associates (CRAs) and 1,300 CRCs, all of whom provide high-quality services through robust training and support systems.
Furthermore, we secure abundant human resources for services targeting pharmaceutical companies, including data management and statistical analysis, as well as services for medical institutions, such as trial secretariats and Institutional Review Boards (IRBs). This ensures our ability to provide a stable service.
Clinical Trial Business
Pioneering the Future of Medicine through Clinical Trials
The clinical trials we conduct are the first step toward realizing innovative medicine, serving as a vital bridge that connects the aspirations of patients, healthcare professionals, and pharmaceutical companies. The EPNextS Group’s Clinical Trial business—encompassing Contract Research Organization (CRO), Site Management Organization (SMO), and global collaboration—is continually evolving to support the development of revolutionary drugs and medical devices right at the trial sites. Our mission is to deliver future treatments to patients as quickly and reliably as possible. To achieve this, we deliver this optimal support by prioritizing “Speed,” “Quality,” and “Trust,” and by adapting flexibly to the changing landscape.
Technological advancements, such as the use of AI and Real-World Data (RWD), are driving increased efficiency and accuracy in drug development. Furthermore, by organically linking our CRO and SMO functions, we deliver comprehensive support, from the initial phase of a trial through to its operation, data capture, and analysis—aiming to reduce the burden on sites while ensuring swift development.
In addition, by strengthening our collaboration with overseas partners and leveraging our global clinical trial network, we are working to create an environment where patients in Japan can access new treatments simultaneously with the rest of the world.
We are committed to walking alongside all stakeholders as a trusted partner in co-creating the future of medicine.
Head of Clinical Trial Business Segment Hisayuki YOKOSE
The EPNextS Group’s Clinical Trial Business
The EPNextS Group is significantly advancing pharmaceutical and medical device clinical trials by enhancing and evolving our CRO and SMO services.
We go beyond simply combining the functions of CRO and SMO (mere addition). Instead, we maximize the synergy between the two (multiplication) to realize the provision of higher-quality and more valuable services.
Pioneering the Future of New Drug Development with Innovative Trial Support
The EPNextS Group's Clinical Trial Business has established a comprehensive system to consistently support domestic and international clinical trials, particularly in Clinical Operations, through EPS Corporation (CRO function) and EP-Link Co., Ltd. (SMO function). Additionally, we operate an SMO business overseas through Total Trial Management Consulting Co., Ltd., a subsidiary of EP-Link Co., Ltd., located in Taiwan.
EPS Corporation, as a CRO, provides integrated services, including planning and proposal development during the trial planning phase; monitoring, data management, and statistical analysis during the trial execution phase; and medical writing and application services during the submission phase.
EP-Link Co., Ltd., as an SMO, maintains a medical institution support system through Clinical Research Coordinators (CRCs) and Site Management Assistants (SMAs) that covers the entirety of Japan, holding the No. 1 market share in Japan.
Clinical Trial Companies of the EPNextS Group
EPS Corporation
A CRO providing end-to-end services, including trial planning, monitoring, data analysis, and regulatory submission support.
EP-Link Co., Ltd.
An SMO providing clinical trial execution support via CRCs, in partnership with nationwide medical facilities.
Total Trial Management
Consulting Co., Ltd.
Consulting Co., Ltd.
A Taiwan-based SMO providing support for clinical trial execution and regulatory affairs across the Asian region.
Our Clinical Trial Advantage
Powerful Acceleration of New Drug Development through:
Delivery × Full Support
Consulting × Specialization
Advantage01
Delivery(Resource Capability and Quality)
Advantage02
Full Support & Consulting
The EPNextS Group's Clinical Trial Business offers comprehensive support for the entire process, from trial planning and execution through to regulatory submission.
In terms of development strategy, regulatory strategy, site selection, and regulatory submissions, our highly experienced members, who possess extensive expertise and proven track records, provide optimal consultation to fully support our clients' strategy development.
Advantage03
Specialization
The EPNextS Group's Clinical Trial Business has extensive experience across a wide range of therapeutic areas, including oncology, rare diseases, psychiatric/neurological disorders, regenerative medicine, dermatology, and vaccines.
Our expert staff, deeply knowledgeable in their respective fields, will offer the most suitable proposals tailored to each client's development objectives and strategies, thereby significantly enhancing the probability of success in clinical trials.
Our Unique Solutions / Value-Added Services
A next-generation remote SDV system that enables secure and direct access to source documents, such as electronic medical records, from remote locations
A service where the EPNextS Group intermediates in referring eligible patients for clinical trials from partner medical institutions to the trial-conducting medical institutions
Supporting the promotion of Patient and Public Involvement (PPI) and patient-centered drug development (Patient Centricity)
A comprehensive, one-stop service for creating video content to be used for procedures such as informed consent
Proposing a Risk-Based Monitoring (RBM) service that is customized to the unique characteristics of each study, leveraging our highly experienced specialists, diverse methodologies, procedures, and tools
Advancing the "Virtual Go" concept to promote Decentralized Clinical Trials (DCT), leveraging our deep expertise in data science and proven track record