EPS Corporation

Company Brochure

Ever
Progressing
SystemLarge Pharmaceutical Market for
R&D Driven Companies
CAGR: 5.0% +Top 3

Patented products(excl. NAS)

Market Sizein the World

CAGR: 10.0% +Patented products(incl. NAS)
NAS: New Active Substances

Japan Clinical Trials and EPS Performance

EPS
PerformanceJapan

MRCT % of
Total Trade

Oncology
Study

Regenerative
Medicine

Rare
Disease65%

1000 +

60 +

200 +

Protocols

Protocols

Protocols

—

—

—

60 %

Approx.

One Stop Platform Ecosystem
EPS Dynamically Responds to and Solves Biotech Companies’ Needs
EPS Established an ecosystem to support foreign biotech companies entering the Japanese market

Japanese
Population
data?

Important
Regulatory
Requirements?

Requirements for
manufacturing,
distribution, sales?

Japan
Unique Processes?

Requirements after
Approval in Japan?

Information
dissemination

Development
Strategy
Consulting

Postmarketingsurveillance
supportManufacturing
Sales
Distribution
SupportGlobal Research Business
EPS Corporation serves as a clinical research“Gateway” to Japan

We provide a One Stop Solution for all your outsourcing needs!

AcrossBordersMulti
Functions

Local
Knowledge

Therapeutic
Area

Our “One Stop Solution” brings
together the individual services
needed by you, our customers.
Seamless communication helps
you understand the status ofeach service and leads yourproject to the optimal quality
completion goal.

Development
Strategy

ICCC (In Country Clinical Caretaker)
SponsorEPS Group companies cover all your service needs, from first-in-man
through to marketed product with our One Stop Solution.

EPS(Acts as ICCC)

Clinical Trial
Vendors

Sites

PhaseⅠ

PMDA

Phase Ⅱ
Phase Ⅲ

Sponsor outside Japan
ICCC inside Japan(EPS)CRO
PMDA◦CTN submission.
◦Safety reporting
including
ICSR/DSUR.

IMP/NIMP◦Confirm
importation
process.
◦Compliance with
GCP and other
J-Regulations.

Submission&
Approval

Sites◦Contracts.
◦IRB documents.
◦Safety reporting.
◦IMP & Lab kit
delivery.

Document
Archive
SMO◦Store essential
documents inaccordancewith J-GCP.

Post
Marketing
Surveillance(PMS)

Clinical Research Services for Pharmaceutical and Medical Device Clients

Site Management and Support Services for Clinical Sites

CSO

4

Drug
Pricing&
Product
LaunchContract Medical Representativeand PMS Services

Global Research BusinessJapan to Overseas & Overseas to Japan

Global Presence of EPS and Partners

EPS supports cross-borders clinical development
By collaborating with strategic partners, EPS utilizes country
specific expertise to seamlessly provide support for overseas
expansion, from consulting to acting as a Gateway for clinicaldevelopment, as well as regulatory compliance.

Global Project management structure
SponsorGlobal PM
Regional PM

RM
CRA

RA

CRA

CRA

DM

MW

RA

RA

Stats

PV

Country A

Country B

ClinicalOperation

Japan

Regulatory Affairs Capability
CountryJapan
South Korea
EPS
TaiwanChina
United States
CanadaEuropeSingapore
Hong Kong
Partners
Malaysia
Philippines
Australia
New Zealand
India

EPS Also Provides a Functional Service Provider (FSP) Model
Flexible and compliant with regulatory requirements

Vendors

Drug
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓

Medical Device
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓

Pharmacovigilance

Data
Science

Project
Management

Regulatory
Consulting

Operations staff coverage
Location
Japan
South Korea
TaiwanChina
United States
United Kingdom
Netherlands
Singapore
Hong Kong
Partners
Malaysia
Philippines
Australia
New Zealand
India

EPS

PM

CO

DM

SA

RA

PV

QM

✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓

✓
✓
✓
✓
✓
✓
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✓
✓
✓
✓
✓
✓

✓
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✓
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✓

CentralScientificAnalysis &Leadership
DSMB
✓
✓
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✓
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✓
✓
✓: Local staff ＊: Central Service

5

Optimal Clinical Development Strategy Package
To reduce complexity,
EPS proposes the most effective Clinical Development Strategy
based on our experiences, knowledge, and opinions of KOLs.
Traditional Model
Consultation with PMDA for Japan development
Phase Ⅰ (Outside Japan)

PhaseⅡ (Outside Japan)

Japan Phase Ⅰ

Join MRCT PhaseⅢ
MRCT Phase Ⅲ (Outside Japan)

New Model (without Phase Ⅰ in Japan)
Consultation with PMDA for Japan development

Based on Population data and Medical Needs
Phase Ⅰ (Outside Japan)

Join MRCT Directly
MRCT Phase Ⅲ

PhaseⅡ (Outside Japan)

Strategic Consultation Team

Clinical
Strategy
Development

Regulatory
Affairs

Informal
PMDA
Meeting
FormalPMDA
MeetingStandard Process of Clinical Strategy
Development & PMDA consultation

Project
Management

Biostatistician

Numbers of PMDA Consultations

13+ years

Quick Study Start Up
Site Start Up

Enrollment & Treatment

To shorten Study Start Up period,
EPS can provide the most effective Study Start Up process bycollaboration with EP-Link (EPS Group SMO company)
EPS Group Proposal

BeforeProject
Contract
After
Project
Contract

EPS

EP-Link◦Competitive study
information(Actual and Forecast)◦Site information◦Enrollment forecast basedon past experiences

Collaboration between
EPS and EP-Link
Proposal of the most suitable enrollment plan

Site Opening and patient enrollment starts

Early opening of Sites
andEnrollment Start

Consideration of
additional sites,
etc.

Contributing to Quick Start after Contract

Data Driven
Site Selection &Recruitment

500+
Relationships with highperforming sites

80% +Met required timeline andpatient recruitment goals.

NEW
NORMAL

Since its founding in 1991, EPS Group has grown as a Japanese pharmaceuticalcontract research organization (CRO) pioneer and a leading company meeting ourcustomers' needs with their drug development. We have made constant efforts to
expand and grow our services to provide One-Stop service which covers Drug
Development to Post-Marketing Pharmacovigilance under EPSHD's groupmanagement. Additionally promoting our Decentralized Clinical Trial (DCT)
platform and creation of new solutions utilizing Real World Data have been
implemented to enhance our business. We will contribute to the development of
the healthcare industry by creating high added value solutions such as new service
models and using digital technologies, and the strength of Japan's largest domestic
site management organization (SMO)EP-Link an EPS company. Moreover, we will
fulfill our mission: contribution to society, optimizing and promoting clinical trials
in Japan which helps solve the drug loss issue in Japan.

EPS will create "the new normal of CROs".
What provides our major “professional service” are human resources. We have
improved our service capabilities through expertise, solid teamwork, and taking
care of and growing our employees in the medium- and long-term time frame.
Also, our business has been expanded by thinking highly of connections withpeople.
As a trusted partner to our customers, we will focus on “enhancement of expertiseand quality of service”,“improvement of productivity and creation of a sustainablegrowth model”, organizational management, work style reform, and “establishingan energetic and positive organization”.
Consequently, we will build the ideal model as “the new normal of CROs”. We arededicated to continuous improvement so as to create a future where people live ahealthy and fulfilling life, and deliver medicine to patients promptly.

Experience

EPS has an overwhelming number of contracts in the field of oncology and clients
think “EPS when it comes to oncology”. Also, EPS has an abundant track record inhighly challenging fields such as Central Nervous System, Cardiovascular, andDesignated Intractable Diseases. EPS is also known as a front-runner in the field ofRegenerative Medicine. In Clinical Trials and Post-Marketing surveillance, we haveestablished a system that allows us to quickly and comprehensively handle
everything from planning to completion. We have earned the trust of our clients forour expertise and responsiveness.

Knowledge Management

Our strengths lie in our ability to provide a full range of services from Drug
Development to Post-Marketing Pharmacovigilance, and our know-how which
covers a wide range of disease areas. At EPS, professionals in various fields are fully
prepared to comply with the regulations such as ICH E6(R3) GCP Principles. The EPS
team is also contributing to the improvement of the industry as a whole bysynergistically utilizing and sharing its knowledge and expertise with other relatedorganizations.

Creation ofValuable Solutions
EPS contributes to the development of
the healthcare industry to shape a future teemingwith health and fulfillment.

Medical Quest

Through the development of pharmaceuticals, we have supported medical care andthe pharmaceutical industry which is an important part of the social infrastructure.
We will continue to contribute to the development of medical care by making fulluse of new technologies and Information and Communication Technology (ICT). In
Decentralized Clinical Trials (DCT), which is expected to become widespread soon,
we have already established a front-runner position and have been implementing a
DCT platform. We intend to focus on the patient engagement and utilization of healthcare
data and further develop our business in the areas of community medicine and healthpromotion. We will continue to be deeply involved in creating a fulfilling living
environment for people by taking a more encompassing perspective view of medicine.

Global Development

Simultaneous global drug development programs with global trials crossing nationaland regional boundaries are increasing in number. We work towards optimizing clinical
trials in Japan and to enhance our business approach to pharmaceutical companies
and startup biotechnology companies with the goal of enabling more clinical trials
to be held in Japan. Also, we are continuing to grow as a global CRO by organizing
systems which holistically support pharmaceutical development.

Takehisa Yamada
Representative Director,
EPS Corporation

EPS'
Targeting Position
Academic
researcher

Pharmaceutical
Company

Medical Device
Company

IVD Reagents
Company

An indispensable partner in resolving
challenging issues

Food withhealth claims
Company

We support your new initiatives with our collective
knowledge and experience. We will propose andimplement the most appropriate solutions.
If you have any such needs or concerns with challenging
issues, please contact us first.

Post Marketing
Surveillance

An indispensable partner in problem-solving thatcan work with you from the start of your project tothe finish line.

Clinical Trials
Clinical Research

DCT platform
1

SafetyInformation

The DCT platform
promoted by EPS

1Considerationof introduction

Planning

EPS is working on building a structure that will support
implement,and operate Decentralized Clinical Trials (DCT) as acentralized service center between not only sponsors and institutions
but also service providers and patients. We offer a one-stop service
throughout the clinical trial life cycle that covers consulting for
preparing a DCT during the study planning phase to reviewing andproposing improvement plans at the end of clinical trials.

Stakeholder
coordination2

Beforecommencement
Introduction
preparation

Planning

DCT platform
Medicalinstitution
support

Improvement
proposals

4

Operation

Review

3

In progress

At the end※ Examples of support contents

11

Patient Engagement Support Solution

Patient Engagement inpharmaceutical development.
We believe that once “patients-centric clinical
trials” get implemented a trustworthy
relationship between our customers and patientswould be built and the domestic clinical trials
would be promoted improving the public image.

Patient Survey Service
EPS Patient Engagement

Patient Interview Service

PLS ＊ Creation Service

Patient Involvement coordinator(EP-Link Co., Ltd.)

Patient Involvement coordinator
Material Review Service

Plain Language Summaries (PLS) A brief description of the clinical trial results in everyday language that is understandable to trial patients and their families
who do not have a medical or scientific background

EPG Groups' Three Unique Strengths

01“Patient Involvement coordinator”,
a specialized profession in patientengagement.
As patient involvement coordinators, our highly expert
CRCs act as a bridge connecting patients who cooperatewith the pharmaceutical development and our clients.

02

Patient engagement support.
As a neutral observer, we unbiasedly
draw out patients’ true opinions with ano direct conflict of interest.

103

Total support fused by
CRO's and SMO's strengths.
The expert diverse teams comprising
members from EPS Group gives full
support from planning to preparing
reports.

CMC Regulatory Affairs

ClinicalDevelopment
Services

In the field of CMC, our expert staff apply highly specialized skills to perform thetasks described below. They deliver regulatory affairs services with impeccablequality in support of customers inside and outside Japan across a broad range ofactivities. Our CMC services range from support for drug substance filings anddrug product approvals to advice on GMP and consistency check.

Data Management

Medical Writing

With one of the largest teams of data
human resources in Japan, we derive
data accurately and quickly, regardlessof the domain or study phase.

In high utilization of quality, speed,
productivity, expertise, and supply
capabilities, we provide reliable support
for all clinical trials including oncology
and other highly challenging clinical trials.

Statistical Analysis

Import Customs Clearance Support, Packaging, Drug Allocation (labeling),
Case Registration, Randomization, Supplying Management andStorage and Delivery Support
We offer comprehensive services of drugs, devices and products used in clinical trials.
Our holistic support covers everything about drugs used in clinical trials, such as
performing a simulation of prepared number of drugs during planning, importcustoms clearance, secondary packaging/blinding, building Randomization and Trial
Supply Management (RTSM) system and preparing for collection and discard.

Development Strategy and Regulatory
Affairs Consultation, Clinical Trial Planningand PMDA Consultation Support

Achieving speedy andhigh accuracy analysis,
we provide full support
from statistical analysis
planning to the reportingof analysis results.

Regulatory submission
outsourcing(eCTD, Gateway)

Clinical Trial
Implementation

We provide a wide range of support fromdevelopment planning to clinical trial planning,
consultation, and project management.

Data Monitoring Committee,
Central Evaluation Support andImaging CRO Services
In a case of using a third party that
evaluates interim data of clinical
trials, we provide full support,
covering planning and reviewing
flow through the reporting results.

Monitoring

Development
Planning

In high utilization ofquality, speed,
productivity, expertise,and supply capabilities,
we provide reliablesupport for all clinical
trials including oncology
and other highly
challenging clinical trials.

Central Monitoring
While utilizing a variety of systems toconfirm the risk status of clinical trials, wewill select the appropriate combination ofcentral and on-site monitoring process.

1

NDA Application

We supports regulatory
submissions from preparation
through approval with awealth of experience and abroad range of services.

Good Clinical Practice (GCP)
Audit
EPS' independent audit
department provides effective
and excellent auditing services.

TMF and Materials Management
We ensure quality by aligning clinical
trial documents with customer needs
and adhering to document
management methodologies thatcomply with both Japanese andinternational regulations.

Post-Marketing
Surveillance
Servicessurveyrting theBefore sta
ervicessulting S
PMS Con

Listing of applicable
SOPs for GPSP and GVP

Support for RMP(Risk Management Plan)
creation

Monitoring
We offer flexible resource planningand efficient monitoring methods
from contract execution and caseregistration and data entry promotion
to termination procedures.

Support forProtocolDevelopment

Medical Writing
Statistical Analysis

Risk Management Plan
Creation
We will propose a scientific andefficient risk management planin compliance with the latest
regulations and support safetymeasures from development
to post-marketing.

Monitoring

Data Management

Contract
negotiations with
Medical Institutions

rvicesection Se
Self-Insp
ervices
eillance S
rv
u
S
g
n
eti
Post-Mark

Data Management

Statistical Analysis

We have one of the best systems inJapan that can participate in all
stages of the investigation process
and contribute to improving theoverall quality and speed of theinvestigation by foreseeing risks.

Full-Support from statistical analysis
planning to analysis results report.

14

Medical Writing
Responding flexibly to clients' requests
for consultation on research plans toefficiently producing high-quality
documents.

Clinical
Research
Services

Medical Writing
We comply with all regulations
and guidelines and deliver highquality documents to meetcustomer needs.

Data Management

Statistical Analysis

With analysis in mind, we
systematically collect andclean data for every
therapeutic area and phase,relaying data of appropriatequality to the next stage ofstatistical analysis.

We enables speedy andhighly accurate analysis
with full support from thestatistical analysis
planning stage toreporting the results.

Thesis publication

Research systems
and structures
Project managers withspecialization in clinical researchbuild optimal systems andstructures for each research project.

Research

Audit
Research planning andConsulting
We provides broad support,
from planning and researchplanning through consultationand project management.

Research plan

15

Research secretariat

Monitoring

As an integral part of clinicalresearch management.we
provide all necessary
support for research
operations.

Customers may selectonsite or central
monitoring, depending on
the risk and required
quality of the research.

System, vendor,
and site audits inaccordance withaudit plans.

https://www.epsi-global.com

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