Vision

Contribution to Healthy and Prosperous
Society Creation
through Comprehensive Support toPharmaceutical R&D
Driven by a strong sense of mission for the contribution to the quality of life andhealth,we, SRL Medisearch, have achieved remarkable growth and solid performance.
We have always contributed and will do our best to support the pharmaceutical R&D ofthe customers,
rendering high quality services with the forefront of analytical technologies andpreciseness at the peripheral services.

Clinical Study
SupportCRO Services

ClinicalResearchSupport

CRO Services

Monitoring Services to Ensure Data Accuracy and Quality

We use our expertise and fields of specialty to help our clients obtain manufacturing
approval.
Monitoring Services
Here at SRL Medisearch, we provide reliable, quality
monitoring services in line with Good Clinical
Practice(GCP), with the aim of bridging the gap between
pharmaceutical companies and medical institutions sothat safe and effective new drugs can be put to gooduse in a clinical setting as soon as possible. One ofthe key factors for success with clinical trials depends
on selecting the right investigator's site and principle
investigator. By harnessing the wealth of information,
experience and expertise that the Miraca Group has built
up through clinical testing in the medical sector, we areable to quickly and reliably implement projects, including
proposals for investigator's sites, in our capacity as anoutsourcer.

QC Services
Quality control (QC) is a service designed to ensure thatclinical trials are conducted in line with GCP and clinical
trial protocols, and that they are adequately monitored.
Services include inspecting documents preparedby Clinical Research Associates (CRA), trial-related
documents submitted to or obtained by medicalinstitutions, and thecontents of records, as well as checking to make surethat monitoring has been carried out at the correct timeand via the correct methods. In addition to being animportant process in terms of effectively moving projects
forward, QC also helps to enhance monitoring skills, byproviding feedback to CRA on items picked up during
checks by QC staff so that they can make the necessary
improvements. Here at SRL Medisearch, we provide highquality clinical trial data throughout our QC services.

Our Experience•Fields of Specialty
Chronic pain fields
Neuropathic pain
Peripheral neuropathic pain
Central neuropathic pain
Infectious disease fields (MRSA/community-acquiredpneumonia)
Dermatological fields (shingles/herpes)
Hepatitis fields (hepatitis C/cirrhosis)

Subjects

Medical institution

Pharmaceutical company
Serviceoutsourcing

Monitoring

SRL Medisearch
Providing
support forpharmaceuticalcompanies
developing
new drugs

CRA

Reliable and Fast Project Implementation

PRT

Clinical trial protocols

ordinance relating
GCP Ministerial
to standards for pharmaceuticalclinical laboratory tests

SOP Standard operating procedures

Quality Control·Checking trial-related documents·Carrying out process checks·Storing and managing trial-related
documents·Ensuring consistency acrossprepared documents·Providing guidance for monitors•Far-Ranging Experience
Global clinical trial experience
Support for English EDC systems
e-Pro support
Direct support for GCP onsite inspections anddocument-based conformity inspections
Support for various monitoring tools
Experience in running various forms of advertising,including newspaper ads

Quality Management Systems and Human Resource Development
Systematically improving and developing to ensure customer satisfaction
Quality Management Systems
Our aim is to continue providing high quality services andaccurate clinical data, so that we can maintain the trust andsatisfaction of all of our customers conducting clinical
trials. To achieve that, each and every one of employees ismotivated by a strong sense of duty and self-awareness of theneed to protect life and people's health. As wellas going about our duties on a daily basis, we also carry out
ongoing quality improvement activities based on our quality
management systems (QMS).

Providing
products andservices

Training,regulations andSOP preparation

Quality
ManagementSystems(QMS)
Management
meetings

Improvements,research andanalysis

Quality Policy
Our employees strive to make ongoing improvements inline with our QMS and provide high quality products andservices to guarantee Customer's satisfaction, based on
the principle that the Customer always comes first.

Human Resource Development
Basic policy on human resource
development
To grow up continuously toward
time to come, SRL Medisearch
regards“human resourcedevelopment”as a primary
importance management subject.
We plan and carry out various
educational training programs forraising human resources with a highsense of ethics and the speciality towork widely.

Leadership

We develop education and training programs designed
to energize individuals and the organization as a whole,taking into account essential skills and abilities thatemployees need to master, as well as leadership. We
also provide support for employee career development.

Professional
development

We are constantly improving specialist training inline with departmental business plans and standard
operating procedures (SOP), in an effort to develop
professional human resources.

Improving
quality andservices

We carry out human resource development with the aimof sharing the values set out in our QMS between all
employees, based on an understanding that everything
depends on the quality of our products and services.

Privacy Policy

We, SRL Medisearch Inc. believes it is its social responsibility to handle personal information including specific personal information
properly under the Privacy Policy given below.
We intend to do our best to protect such information by improving the system and management method for the protection ofpersonal information.
1. Observance of laws and regulations
We comply with laws, regulations, and executive orderregarding the proper handling of personal information
including the Act on the Protection of Personal Informationand the Act on the Use of Numbers to Identify a Specific
Individual in the Administrative Procedure.

3. Safety measures
Our policy is to take preventive measures against theforecasted hazard to which the personal information isexposed, such as illegal access, loss, destruction, alterationand leakage and to take suitable countermeasures should an
incident or accident occur.

2. Proper handling of personal information
We specify the purpose of use to collect, use, disclose
personal information in a proper and fair manner within thelimits of necessity in connection with the execution of ourservices.
We handle personal information to be collected within thescope of purpose of use and take measures to prevent any
such information from being used for any other purpose.

4. Request for disclose and complaints handling
We faithfully and swiftly correct, add, delete or suspend
corresponding information based on verification of therequest.
Kaoru Nakajima
President & CEO
SRL Medisearch Inc.

Clinical Study Support

Full Support, from Preparing Sample Collection Kits to Coordinating Operations
Establishing the best partnership to meet our customers' varying needs

Clinical laboratory tests are essential to all companies and organizations conducting clinical trials.
As professionals in handling clinical laboratory test data, we specialize in clinical trials here at SRL
Medisearch and offer support for customers engaging in harmaceutical R&D.In the field of new drug
development, driven by the need to provide highly effective and safe pharmaceuticals of the highest
quality as quickly as possible, we provide cutting-edge analysis technology and precise, high qualityservices. Combining advanced technologies, a wealth of expertise, an extensive distribution networkand effective IT solutions, we aim to establish the best partnership possible with our customers andinvestigator's site, as part of our comprehensive support services for pharmaceutical R&D.

Preparationof sample
collection kits

Site registration

Collection

Samplemanagement

Transportation

Boxes fordifferent storage
temperatures

Data
management

Provision ofdata

Deliveryby airDeliveryby roadSRL

Our uniquelydeveloped collection
boxes are divided
into three sections(room temperature,refrigerated andfrozen), to ensurethat samples
are collected
at the optimumtemperature.

Samplecollection andtransportation

We use a rangeof distribution
networks totransport samples
quickly andsafely.
Pre-analysis maintenance andmanagement
We store samples for PK or PD
analysis in a deep freezer at -80°C.

Web-Based Ordering System

Post-analysis maintenance andmanagement
As a rule, we store any remaining
samples after analysis (blood serumor plasma) in a freezer at -20°C
until the end of the study.

Orders for sample collection kits, setup, and sample collections can all be requested online.
Our web-based ordering system is accessible from anywhere at any time, and even allows
customers to check the status of their orders.

"Sizai-Navi""Setup-Navi""Site-Navi"

Comprehensive Support Underpinned by the Latest Technology
Precisely catering to customers' needs as a leading company

Central Laboratory for Clinical Trials
At our central laboratory, we carry out the safety
testing and PK/ADA analyses essential to clinical
trials. We are ISO-15189- and CAP-certified, andoperate as a Good Laboratory Practice (GLP)
facility.

Support for Molecular-Targeted Drug
Development (Biomarker Screening)

Biomarkers
We handle a wide range of biomarkers, including the following.
· EGFR (HER1) · HER2/erbB2 · K-RAS · C-KIT (DNA)· FGFR · EML4-ALK · c-Met and more

We conduct a wide range of tests integral totoday's precision medicine, including genetic tests(NGS/qPCR), IHC staining, and FISH testing.

Biological Safety Testing(Quality Testing)
We carry out various quality tests set forth by
the ICH for biopharmaceuticals and cell/tissueengineered medical products using biologicaltechniques.

Mycoplasma detection
using culture method

Viral CPE assay (in vitro)

Mycoplasma detection
using DNA staining

Global Clinical Trials
We serve as a single point of contact for global
clinical trials, providing projects with the samefull-support system as our central laboratory
services in Japan.
By linking up services with leading test centersthroughout Asia, we can, for instance, offer
accompaniment during Site Initiation Visits (SIVs),
sample collections from sites, and more efficientinternational shipping costs, so that overseas
clinical trials go forward smoothly.

Breast cancer tissue
EGFR (HER1)

Breast cancer tissue
HER2/erbB2

Quality Tests
1) Sterility testing (Japanese Pharmacopoeia)
2) Mycoplasma testing (Japanese Pharmacopoeia, biologicalproduct standards)· Culture methods, DNA staining, PCR
3) Endotoxin testing (Japanese Pharmacopoeia)
4) In vitro assays for CPE, HA and HAd5) Virus-free testing· HBV, HCV, HIV-1, HTLV-1 and B19V
6) Other tests (potency assays, etc.)◎ We carry out tests at two different levels, according to thesponsor's requirements.
1. Study-related documents review by QAU in line with the reliabilitystandards for application documents as stipulated under Article 43
of Pharmaceutical and Medical Device Act.
2. Tests at GLP facilities, carried out by GLP organizations (QAU forfacility tests only)

Medisearch Model
Linking up services
with some of Asia's
leading test centersSouthKorea

SRL
MedisearchPhilippines

TaiwanJapan

Singapore

Malaysia
China

Hong
Kong

ThailandClinical Research Support

One-Stop Support for Clinical Research

We provide consistent support from the preparation stage all the way to the finish, focusing
on the testing needed to build evidence for clinical research.
Establishmentof researchgroup

Drafting ofresearchplan/ICforms/CRF
Participating
facility
supportOther clinicalresearchrelated
services

Testingcentric
support

Auditing

Subject
registration

Establishment of Research GroupAs a research office, we support all operations
involved in the launching of the research,
including preparations, scheduling, and kickoff
meetings, through briefings with research
representatives.

Drafting of Research Plan/IC
Forms/CRF
We prepare drafts of any research plans,
informed-consent-related briefing materials,
and case report forms (CRF) needed for clinicalstudies.

Participating Facility Support
For participating facilities, we coordinate support
for applications to ethical review boards andcontracted research agreements. We also holdstartup meetings and coordinate testing materials
and operations, as well as briefings on theresearch protocol and methodology, and any othernecessary coordination.

Datamanagement

Monitoring

Subject Registration /Data
Management
We create electronic data capture (EDC) systems
for registering subject data and collecting survey
items. We also manage data by controlling andcoordinating operations throughout the durationof the research.

Monitoring
To control the quality of the research, we prepare
monitoring plans in line with the research design, andconduct both central monitoring and onsite monitoring.

Auditing
We perform auditing according to audit plans inorder to assure the quality of the research.

Other
Clinical research-related services

・We have access to testing knowledge, testing techniques (SRL), and a nationwide
sample collection network.
・We possess GCP-based project management knowledge, expertise, and skills,
grounded in our experience with pharmaceutical development support andmulticenter study support.
・We command a wide-ranging network, including our Group and business partners.