CONFIDENTIAL

3H Medi Solution
Global Capabilities

3H Group Introduction

CEO: Ando Sho
Founded: 2009

CEO: Takizawa Hirotaka
Founded: 2005

Planning・Management・Consulting・Sponsor contact

Recruitment・Database・Call center

CEO: Takahashi Yoshinori
Founded:2015
SMO•

First in Japan Consulting CRO
specializing in patient recruitment•

Japanʼs largest patient recruitmentcompany• Japan only SMO able to recruit
patients•

Provide unique patient recruitment
strategy•

Holds patient database of over
820,000 nationwide• Provide solutions to sponsors andsites needs•

Feasibility service using IT such as
Google Map (PASSMAP) anddatabase•

Over 300 diseases and symptoms
database suitable for clinical trials•

90+ seats call center specializing inclinical trials• Patient community enables the SMO
to maximize the enrollment with less
sites

•

Online and offline recruitment
strategies to connect with potential
patients•

Oncology one of its kind in Japan
which provide the solution forOncology Clinical Trial.

•

Highly accurate area and site
selection service•

A system (REGUSYS) to prevent dual
entry of the patient•

Vendor management by patient
recruitment specialistsv

Copyright © 3H medi solution• Enrollment planning for out-patientsand referral patients• Using the Clinical Trial database
increases enrollment with lower cost.

2some pretty spectacularstatistics..

3H Milestone
3H

3H

(Max)

v

Copyright © 3H medi solution

3

CASE STUDY

Phase II Study // Hot Flash/Menopausal Syndromes

Project Summary //SponsorJapanese Pharma

Support from CROee Patient recruitment advertisement
Timing ofconsultation

Throughout trial

TargetHot Flash/ Menopausal Syndromes# of site

17

Target area

All Japan

Medias used

DB, Web ,Newspaper Inserts

Impressive Number //Expert Analysis //Hot flash is said to occur in around 10% of women in Japan. Despite
the high incidence rate, only 50% of patients got diagnosed andreceive treatment because it is the disease that makes it difficult forpatients to realize that they are the patients of the disease and toencourage themselves to go the hospital.
For this study, CROee decided to plan the campaign very
strategically, because the planning in a situation where there was
not affluent information on the potential patients visiting the medical
institution as well as recruiting the mild to moderate hot flash or
menopausal syndromes patients by the set of online campaign aswell as Newspaper Inserts.

50

Hot Flash becomes more prevalent with oldage, and more than half of those are over
50 years of age with this symptom. However,
50% of people try to endure the symptoms without
receiving treatment, and 50% of people even after
having severe climacteric disorders do not do anything.
As a countermeasure, they take supplements, do
exercise or take herbal medicine and without going tohospital. So we targeted the group of this 50% mainly
and succeeded in recruiting the patients. Newspapers
inserts and call centre script made with the help ofgynaecologist expert patient recruitment specialist
played the vital role to convince the patient to go to thehospital and try the new medication which was the oneof the main sources to enrol the patient. Enrolling only
from the sites would have not been that much successful.

CASE STUDY

Phase-Ⅲ Study// OA
Project Summary //CROee Support

Patient recruitment advertisement

Timing of consultation During Clinical Trial
TargetKnee OA, Hip Joint OA

Sites

67

Target Area

All Japan

Tactics

DB, Newspaper・Inserts, Web

Impressive Number

Expert Analysis//
Many people with OA do not get seen by a doctor, and many
will use medications only when they cannot bear the pain.
Therefore, the number of people who visit doctors regularly
is low. CROee’s recruitment advertisements focused on
recruiting those who are troubled by pain rather than onwhether they were receiving treatment for OA or not. Also, toreduce the burden of first visit charge and referral form
charge, we suggested transportation fee reimbursement. As
a result, we could get more patient to participate andachieved 180% of the planned number of randomizations

60

OA becomes more prevalent with old age, andmore than half of those over 40 years of age aretroubled by pain. However, 60% of people try toendure the pain without receiving treatment, and 60% of people
are not satisfied with their treatment outcome. CROee usednewspaper advertisements to target these 60%, and lead many
people to consider doctor visits or new treatment options. This
lead to the successful recruitment of a patient group that could
not have been recruited within sites.

Plan vs Result //Plan

Result7 Months

7 Months

Referrals

668

1,295

Registered

35

63

Recruitment Period

CASE STUDY

Phase III Study //Alcoholism
Project Summary //CROee Support

Patient recruitment advertisement

Timing of consultation Before the Trial
TargetAlcoholism

Sites

80

Target Area

All Japan

Tactics

DB, Inserts, Web

Impressive Number

2

Alcohol dependence is called the “disease of denial”,
and it is difficult for patients to realize their disease

andExpert Analysis//
Although this is a condition with many potential patients, we
had no information regarding patient profile for those that
visit hospitals (severe disease) and those that are ourrecruitment targets (mild ~ moderate disease). Therefore,
we ran a pilot plan to test our hypothesis on a small scale,and used the result to characterize the second screening.
The recruitment plan was modified twice during therecruitment period. Through strategical planning andoptimization, we achieved 115% of the achievement target
within 4 months.

receive treatment. Patient eligibility was confirmed
through the call centre in two steps, the second step
being a hearing held by qualified staff such as clinicalpsychologists (2ndscreening). This allowed us to successfully
recruit for alcohol dependence, which was considered a very
challenging project.

Plan vs Result //Plan

Result14 Months

10 Months

Referrals

1,996

1,079

Registered

500

575

Recruitment Period

CASE STUDY

Phase III Study // Overactive bladderProject Summary //CROee Support

Patient recruitment advertisement

Timing of consultation Before the Trial
TargetOAB wet

Sites

107

Target Area

All Japan

Tactics

DB, Inserts, Web

Impressive Number //76.6

Expert Analysis //An example of successful site selection. The sites selected
for this study were all very favourable for the referredpatients in terms of location and time slots for visits.
Especially 95% of the sites were within 10 minutes walking
distance. The visit rate of referred patients was 76.6%,
which is significantly higher than the average of 40~60%.
Also, by being stringent with the selection criteria forreferrals, less than the anticipated number of referrals were
made, resulting in decreased burden for sites.

When the number of referrals are high,sites cannot handle contacts with thesubjects in a timely manner, resulting inincreased numbers of unresponsive patients or cancellations.
The contact center helped with coordinating the first visit andpassed on information about the patient onto sites, resulting in ahigh first visit rate after referral and an effective path torandomizations.

Plan vs Result //Plan

Result6 Months

6 Months

Referrals

1,579

684

Registered

500

473

Recruitment Period

CASE STUDY

Phase II Study // Endometriosis

Project Summary //Support from CROee Patient recruitment advertisement
Timing ofconsultation

Throughout trial

TargetEndometriosis# of site

15

Target area

All Japan

Medias used

DB, Web

Impressive Number //10Expert Analysis //We started with advertisement strategies that are said to be thegold-star standard for patient recruitment, but few patients meeting
the inclusion criteria showed up. Advertisement design andmessages also had influence on the type of patients that ended up
responding, which had mostly mild symptoms. Halfway through thestudy, we altered the advertisements and brought the surgery
criteria to the forefront. This resulted in an increased number ofpatients that met the criteria, but was not sufficient for us to recover
before the recruitment period ended.

Endometriosis is said to occur in 5-10% of
women. Despite the high incidence rate, only
10% of patients receive treatment. For thisstudy, only patients diagnosed by laparoscopy andlaparotomy were eligible. Under this inclusion criteria,
CROee’s feasibility research revealed that only 10% ofendometriosis patients would be eligible. Depending on the
inclusion criteria, diseases with high incidence rate may
require strategies as vigorous as those for rare diseases.

Plan & Results //Plan

Result3 months

5 months

Referrals

68

39

Registered24

1

Recruitment Period

CASE STUDY

Phase III Study // Schizophrenia

Project Summary //CROee Support

Patient recruitment advertisement

Timing of consultation During the Trial
Targetschizophrenia

Sites

13

Target Area

All Japan

Tactics

DB, Web

Impressive Number //２Expert Analysis //Follow-up with patients over the long span of 2 years tomonitor changes in their disease state is something that
could only have been done because of our volunteer
database. By regularly following-up with patients, thecommunicator built a trust relationship with the patient.
Because of this, the patient was willing to call us to andreport changes in their disease symptoms, which made it
possible for them to clear the difficult criteria of visiting thesite during an acute exacerbation.

Schizophrenia has a bipolar nature which consists of“on” and “off” periods. This study’s targets were
patients who were experiencing an acute episode of“on”. Because it was difficult to predict when patients would
have an episode, we recruited patients who were stable andfollowed-up with them biweekly so that we would be able tocatch them when they were close to having an episode andrefer them. This was a strategy that required communicationand trust between the communicator and schizophrenic
patient..

Plan vs Result //Plan

Result27 Months

24 Moths

Referralsー8Registered4

3

Recruitment Period

Seikatsu Kojo Website

l Japan's largest healthcare
information and monitoring
information website
l 840,000 member databases thatwould like to participate inmonitorsl More than 200 diseasecategories
l More than 100,000 clinical datal More than 150,000 dosing
informationl More than 10,000 monitor
referrals per year
l Able to make disease awarenessads and advertise clinical trials● Steering Company 3H Clinical Trials K.K.
● Media Name ”Seikatsu Kojo Web"□URL http://www.seikatsu-kojo.jp/● Ratio of male to female: 1:1□ Monthly PV count 2 million PVs● Number of monthly visitors 300,000● 10,000 patients enrolled per month

STRICTLY PRIVATE AND CONFIDENTIAL Copyright 2019. 3H medi solution Inc.

10

Database(880,000 Patients)

94,000 people

138,000 people

71,000 people

35,000 people

73,500 people

1,800 people

14,300 people

26,000 people

38,500 people

102,000 people

15,200 people

8,800 people

18,000 people

880,000 people

14,900 people

6,800 people

5,300 people

694,000 people

Registered different conditions
Registered conditions
Disease by categoriesv

Database(880,000 Patients)
Registered Conditions TOP50
RANK

Disease Name

# Registered

RANK

1

Hypertension

37,681

2

Seasonal Allergy

33,7753Hyperlipidemia

4

Allergic Rhinitis

5

Disease Name

# Registered

26

Appendicitis

2,700

27

Iron-deficient Anemia

2,654

27,20228

Allergic Conjunctivitis

2,602

19,68629

Sinusitis

2,527

Insomnia

15,14530

Endometriosis

2,470

6

Depression

13,65931

Chronic Urticaria

2,463

7

Bronchitis

12,84632

Dysmenorrhea

2,392

8

Atopic Dermatitis

12,04333

Glaucoma

2,091

9

Acne

11,45634

Type I Diabetes

2,086

10

Type II Diabetes

9,679

35

Panic Attack

1,910

11

Uricemia (Gout)

9,237

36

BPH

1,709

12

Venous Thrombosis

9,151

37

Angina Pectoris

1,632

13

Tinea Pedis

7,967

38

IBS

1,611

14

Back Pain

6,371

39

Schizophrenia

1,563

15

Dry Eye

5,880

40

Carpal Tunnel

1,516

16

Constipation

5,757

41

Rheumatoid Arthritis

9,447

17

Hypertriglyceridemia

5,568

42

Menopause

1,374

18

Uterine Fibroids

4,554

43

Cataracts

1,342

19

Peptic Ulcer

4,355

44

Chronic Gastritis

1,325

Myocardial Infarction

1,194

Pneumonia

1,165

20

Overactive Bladder

4,277

45

21

GERD

4,225

46

22

Osteoporosis

4,195

47

Arrhythmia

1,105

Dysautonomia

997

23

Alzheimer

4,011

48

24

Shingles

3,698

49

Joint Deformation

974

25

Duodenal ulcer

3,071

50

Seborhheic Dermatitis

939

Copyright © 3H medi solution

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Membership information data in possession
Item

Contents

Hematology parameters
WBC count

Total Bilirubin

Uric acidRed blood cellcount

AST(GOT)】

Nitrogen urate

Age/SexMale/female age

Address

National prefectures/national municipalities

Date of birth

Day of birth

Hemoglobin
content

ALT(GPT)】

Creatinine

Height/Weight/BMI

Height (cm)/Weight (kg)Hematocrit

ALP

Na

Date of completion

Date Month Year

MCV

LDH

K

Occupation

Students, company officers, officials, civil servants, self-employed, nonemployed, freeters, housewives, etc.

MCH

y-GT

CI

Drinking/Smoking

Drinking (yes/no) Smoking (yes/no)

MCHC

CPK

LDL cholesterol

Desired information

Clinical trials, beauty care, cosmetics and health foods

Platelet countHemoglobin A 1 C

Desired guidance
methodTelephone, e-mail, fax, and direct mailFasting plasma
glucoseTP

Total cholesterol

Systolic blood pressure (top)Desired contact time

Weekdays, Saturdays, Sundays, and Hours

A/G

HDL-ChoMedical information

Disease information, blood test data, medication information, etc.

Diastolic blood pressure(bottom)

ALB

TriglycerideTime of data extraction

Area

Disease name * All disease categories are more than 300

Endocrine metabolic
diseaseType 1 diabetes mellitus, type 2 diabetes mellitus, suspected diabetes mellitus, obesity, hyperuricemia, hypercholesterolemia, pediatric, etc.

CardiovasculardiseaseHypertension, atrial fibrillation, angina pectoris, heart failure, venous thrombosis, etc.

Digestive disorder

Ulcerative colitis, reflux esophagitis, gastric ulcer, Crohn's disease, irritable bowel syndrome, taste disorder, etc.

Respiratory disease

Bronchial asthma, pneumonitis, chronic obstructive pulmonary disease, respiratory infection, COPD, pediatric, etc.

Orthopedic disease

Low back pain, osteoporosis, rheumatoid arthritis, osteoarthritis of the knee, etc.

Neurologic disorders

Sleep disorder, sleep apnea syndrome, Alzheimer's dementia, other dementia, Parkinson's disease, Restless syndrome, cerebral infarction, pediatric,etc.

Psychiatric disorders

Schizophrenia, depression, social-anxiety disorder, anorexia, PTDs, panic disorder, epilepsy, bipolar disorder, pediatric, etc.

Renal, hepatic, andbiliary diseases

Renal impairment, hepatitis B/C, tumor, cirrhosis, liver dysfunction, etc.

Skin disease

Acne vulgaris, psoriasis vulgaris, atopic dermatitis, chronic urticaria, tinea unguium, herpes zoster, seborrheic dermatitis, pediatric, etc.

Recruitment outreach (Online/Offline)
Media outreach•Study specific page•

Online Media outreach•

Offline Media Outreach•

KOL study session, lecture, seminar•

Disease awareness events•

Physicians referral•

Pharmacy outreach•Direct Mail
About
220,000

Event
v

About
1,410,000
About
3,000,000
Copyright © 3H medi solution

About 2,300,000

14Site Supporting Tools
Site supports

INSERT GRAPHIC•

Poster•Brochure•

Pocket Protocol•

Newsletter to physicians•Video tool•

iPad tools•

KOL Video•

Recruitment Training to site staffs

Recognition of the study at sites increaseby providing materials and tools that will
motivate study coordinators and site
staffsv

Copyright © 3H medi solution15

3H Group Features ＆ Digitization Activities『A specialized company that recruits subjects』
Volunteers-Our position-

Networks

Can know“the patientʻs voice”

Sponsor

3H-Group856,000

Patients

・Oncology・Rare Disease
・Pharmacy『Approach : "Patient-centered / Digitizing” for Virtual clinical trial』
Virtual-ct
Home Visit -ct

Planning with the University of Tokyo
Home visit clinical trial ʼs with Physicians

App

Development method reflecting patient opinion

IoT

Introducing IOT for Patient Centricity

Provisioning

Device delivery management（Japan's only mechanism）

Recruitment

Web contents for each disease / contents for IC support

3H P-Guardian
Patients

Medicalinstitutions

Medical information

Cancer Information Sites"oncolo"EHR Server

Electronic medical
records

Guardian
EMR Server
PHE-HERTo view the data

Wearable devices

Alert

Family PC/Smartphone

Cloud PHR Server

Remote second
Opinion application

Pad

Existing Zervis Oncole

Use of accumulated data

Application to Clinical
TrialsAI Algorithm
Implementation

Patient PHR Registry,
Cooperation between PHR Servers and EHR Servers, etc.

Simplifying clinical trials
Cost reduction
EDC Server

17In Home Clinical Trial Service
3H In-Home Clinical trial Support Model for Japan

Patients at home

Nurse

Study Site

Central Lab
Sponsor

Following services are based on RFP request.
･Study set-up･In home materials, Site set up, IM･In-home visits･Nurse setup & training･Visit coordination & management

Medical Information Provision Formeconsent(planned)

Completed
VirtualStudy for
ONCOLOGY

analysis
Alert

Study Details: Siteless Virtual Study of Adverse Event Monitoring Applications in Cancer Patients
site less Virtual Study for Validation of Adverse Events Monitoring Application in Oncology
Indication: Projected number of subjects with advanced cancer
Patients: 100 subjects
Study Period: November 2019 to March 2020
Objectives: P-Guardian Systems Validation and Exploration of Changes in Patients' Quality of Life
Scheduled scale: PRO-CTCAE(Weekly), FACT-G(Monthly)
Sensor-Acquisition Scale: Activity (Calorie, METs), SpO2, Heart Rate, Sleeps

Offices and affiliated Investigational Sites

Kanto area
Tokyo : 57 sites
Saitama : 3 sites
Kanagawa : 10 sites
Total : 70 sites

Kansai area

Tokyo Headquarter

Osaka : 26 sites
Hyogo : 8 sites
Total : 34 sites

Hachioji Office

Kyushu area
Fukuoka : 22 sites
Total : 22 sites

Osaka Office
Fukuoka Office*The site number above represents our core sites*The
as investigationalsite is over 300© 3H medi solutionv actual number of sites we have made contractsCopyright20

Asian Network of 3H medi solutionv

Copyright © 3H medi solution21

Merit behind 3H medi solution
Asian Network

Local
CRO

SMO

Advertising
AgencyDatabase
Company

AdvocacyGroup

1.

Covering all the necessary tactics for patient recruitment with local Vendors/Support.

2.

Inculcating local vendors with the Know-how of Japanese PRO and Quality.

MedicalInstitution

3. Our local vendor are well-versed in local clinical trial regulations and culturally affluent.
4. Multiple country project management by 3H medi solution Global professional of patient recruitment
5. Managing the referred patients at sites from Referral to Randomization by referral management system(iPASS+)v

Copyright © 3H medi solution22

Referral Management System: iPASS+
ReferralFirst VisitIC
Development
Development
PhaseⅠ〜Ⅲ

Randomization

Market launch

Recruited

Post-market

iPASS+ is a system to provide referrals information to thesite securely. All the referrals from our advertisement will
be screened through our call centre. All the information
about referrals will be uploaded to iPass+ Each site canlog in to the iPASS+ with ID & password to view referral
information.

v

Copyright © 3H medi solution

23

Thank you
To know more please contact:

imran@3h-ms.co.jp