EPNextS,Inc.

Clinical Trial Business

Advancing Drug Development through Integrated CRO and SMO Expertise

Clinical trials are essential to modern drug development. They provide scientific validation of a therapy’s safety, efficacy, and quality before patients receive it in clinical settings. Because trials must be conducted under strict regulatory oversight and ethical standards, they require coordinated operations—from protocol planning and patient enrollment to monitoring, data handling, and reporting. As a leading Contract Research Organization (CRO), the EPNextS Group supports pharmaceutical companies, biotechnology innovators, and healthcare institutions by delivering precise, efficient, and globally compliant clinical trial services.

In Japan, the EPNextS Group also fulfills the role of a Site Management Organization (SMO). Although the term “SMO” may be less common outside Japan, it plays a crucial role in the country’s trial infrastructure. EP-Link, our SMO subsidiary, supports hospitals and clinics nationwide, ensuring smooth site initiation, consistent patient enrollment, and accurate data collection. By providing hands-on operational support, EP-Link bridges the gap between detailed protocols and the realities of daily clinical practice.

By combining CRO strategies with SMO execution, the EPNextS Group offers a unified operational model that reduces delays, strengthens data reliability, and improves overall trial quality. This structure is especially valuable for multi-center studies, rare disease research, and specialized trials requiring close collaboration with healthcare professionals.

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 is committed to improving the way clinical trials are conducted. Our focus is not only to follow conventional methods, but to introduce approaches that make trials more efficient, more accessible, and more patient-centered.
We incorporate digital tools, real-world data, remote monitoring, and decentralized trial models that help reduce patient burden, minimize travel requirements, and maintain continuity even in changing healthcare environments. These innovations enable sponsors to run complex studies more smoothly while ensuring scientific integrity and compliance with regulatory standards.
Such advancements are particularly impactful in rare diseases, pediatric studies, long-term follow-up research, and trials involving geographically dispersed patients. By enabling participation regardless of location and by modernizing trial operations, we help make groundbreaking treatments available to patients earlier—without sacrificing quality or ethics.

Clinical Trial Companies of the EPNextS Group

EPS Corporation
  • Study planning and protocol development
  • Feasibility assessments and regulatory consultation
  • Monitoring, data management, biostatistics, safety operations, and medical writing
  • Support aligned with international standards for global development
EP-Link Co., Ltd.
  • One of Japan’s largest CRC and SMA networks
  • On-site operational support, patient engagement, and adherence to trial procedures
  • Smooth coordination with physicians, nurses, and research departments
Total Trial Management
Consulting Co., Ltd.
  • SMO support in Taiwan and across Asia
  • Local regulatory communication and cross-border coordination
  • Strengthening Asian clinical execution in cooperation with EPS and EP-Link

Our Clinical Trial Advantage

Powerful Acceleration of New Drug Development through: Delivery × Full Support
Consulting × Specialization

Advantage01

Strong Delivery Capability

With approximately 1,100 CRAs and 1,300 CRCs, we maintain one of the largest delivery infrastructures in Japan.
All personnel receive standardized training in GCP, patient safety, monitoring, and communication.
Specialized teams support data management, biostatistics, safety management, and trial secretariat functions.

Advantage02

Comprehensive Support and Consulting

We assist sponsors throughout the entire clinical development process—from initial planning to regulatory submission.
Our consulting includes protocol design, feasibility evaluation, patient recruitment strategies, risk-based monitoring design, and global submission planning.
We build development plans that are scientifically sound, ethically responsible, and practically feasible.

Advantage03

Specialized Medical Expertise

We have extensive experience in oncology, neurology, dermatology, regenerative medicine, rare diseases, and vaccines.
These therapeutic areas require advanced scientific knowledge and long-term observation.
Our experts support high-quality study execution, patient safety, and data reliability in complex trials.

Value-Added Services

SYNOV-R

A remote SDV system allowing secure access to electronic medical records and other source data, reducing travel and improving monitoring efficiency.

Patient Link

A patient referral network connecting suitable participants from partner clinics to trial sites, contributing to faster and equitable enrollment.

PPIVoicebook

A solution promoting Patient and Public Involvement (PPI), helping sponsors incorporate patient perspectives into trial design and decision-making.

Consent Support

Video-based informed consent support that provides clear, easy-to-understand explanations for patients and families, improving comprehension and transparency.

Risk-Based
Monitoring
(RBM)

Monitoring plans designed by experienced specialists who focus on essential data and reduce unnecessary workload.

Virtual Go

A data-driven decentralized clinical trial (DCT) model enabling remote participation for patients who cannot regularly visit investigational sites.

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