CONFIDENTIAL人の健康と幸せをつなぐH 3H Medi Solution Capabilities 3H Group Patient Centric Services Oncology & Orphan Disease In Home Clinical Trial Asian Network
3H medi solution CEO: Ando Sho Founded: 2009 Planning • Management • Consulting • Sponsor contact . First in Japan Consulting CRO specializing in patient recruitment . Provide unique patient recruitment strategy . Feasibility service using IT such as Google Map (PASSMAP) and database . Highly accurate area and site selection service . A system (REGUSYS) to prevent dual entry of the patient . Vendor management by patient recruitment specialists
3H clinical trial
CEO: Takizawa Hirotaka Founded: 2005 Recruitment • Database • Call center Japan's largest patient recruitment company Holds patient database of over 820,000 nationwide Over 300 diseases and symptoms database suitable for clinical trials 90+ seats call center specializing in clinical trials Online and offline recruitment strategies to connect with potential patients Oncology one of its kind in Japan which provide the solution for Oncology Clinical Trial. 3H cts CEO: Takahashi Yoshinori Founded:2015
SMO
• Japan only SMO able to recruit patients • Provide solutions to sponsors and sites needs • Patient community enables the SMO to maximize the enrollment with less sites • Enrollment planning for out-patients and referral patients • Using the Clinical Trial database increases enrollment with lower cost. 3H Milestone some pretty spectacular statistics.. 3H is providing its services to 15/TOP, 20 Global Pharma 3H   has worked with 26/TOP 30 Japanese pharma We have referred the patients to more than We support clinical trials/year Subjects enrolled in last 5 years. Our patient recruitment supports contributed to reduce the clinical trial
● Japan's largest healthcare information and monitoring information website ● 840,000 member databases that would like to participate in monitors ● More than 200 disease categories ● More than 100,000 clinical data ● More than 150,000 dosing information ● More than 10,000 monitor referrals per year ledia 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. 3日
Database (880,000 Patients)
Database (880,000 Patients) Registered conditions Disease by categories Circulatory Malignant Tumor · Pediatric
Endocrine Registered Conditions TOP50
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Collection of patient voices from our 856,000 database members using: internet, contact center, mail surveys, face-to-face, communities…etc., Segmented data relating to diseases, lab stats, drug administration are also attainable. 856,000members >583 disease categories ● Disease data 250,000 ● Laboratory data 150,000 ● Drug use data 350,000
Internet Research
On patients with specific diseases is possible even with a low budget over a short period hone Research Member hearing conducted nationwide by specialized communicators Mail Research Most suited towards elderly members Original copy of survey can be kept for records Community Research Best method for observational day-to-day records such as patient occasion and disease status
Depth Interview
For hearing the patient's real voice which may be sometimes difficult with surveys (insight research) Group Interview Conduct insight research efficiently through open- discussion forums with patients iJ6JiJ06 itstile
 016929

Online survey
Compatible with most devices
Digital diary
Diet, lifestyle, medication intake, health status, etc. are recorded
Mobile behavior observation
Observe patient behavior through app installed on 3H’s C-Phone device Patient journey Visualize patient action/feelings: Disease onset→Hospital→ Diagnosis→Prescription→Medication
Online forum
(MROC) Members with the same health
Social media analysis
Extract disease and health information through social media and analyze

Media outreach
● Study specific page o Online Media outreach o Offline Media Outreach o KOL study session, lecture, seminar o Disease awareness events o Physicians referral o Pharmacy outreach ● Direct Mail MEDIAFLAG About 220,000 About 2,300,000

Site supports
。 Poster 。 Brochure 。 Pocket Protocol 。 Newsletter to physicians 。 Video tool 。 iPad tools 。 KOL Video 。 Recruitment Training to site staffs Recognition of the study at sites increase by providing materials and tools that will motivate study coordinators and site staffs Oncology Department some pretty spectacular statistics.. 14
3日100+ KOLs Over 100 cancer specialists support Many professors/deans Oncolo Medical Supporter A medical representative who agreed to cooperate with 3H Oncolo information site.
Our website is visited not only by patients, but also by many pharmaceutical/medical related staffs 16
Triple-negative breast cancer Muscle-invasive bladder cancer Esophageal cancer Low-grade Non-Hodgkin Iymphoma GIST Rare cancer (baske Small-cell lung cancer. Non-metastatic castration-resistant Malignant pleural mesothelioma Achievement（include plans） : More than 80 trials: Brain tumor : 2、Head and neck cancer : 1、 Salivary gland cancer : 1、Non-small cell lung cancer : 9、Small-cell lung cancer : 3、Breast cancer : 5、Malignant pleural mesothelioma : 5、Esophageal cancer : 2、Gastric cancer : 2、Hepatocellular carcinoma : 1、Renal cell carcinoma : 2、Bladder cancer : 3、Colorectal cancer : 1、GIST : 1、Prostate cancer : 1、Malignant lymphoma : 6、 Leukemia : 7、Multiple myeloma : 1、Rare cancer basket study : 1、Melanoma : 2、Unknown primary cancer : 1、Solid cancer : 1、Bone metastasis sarcoma : 1、uterine carcinosarcoma : 1、Small intestine adenocarcinoma : 1、Glioma : 1 • Ads for hematologic cancer are increasing and has a very high responsive rate • Ads for immune checkpoint inhibitor is decreasing but has a high responsive rate • Connections with sites go up and  medical investigator trials are increasing as well BRCA breast cancer
◆Rare disease information site RareS. ◆URL：https://raresnet.com/ ◆since : 2018 Feb～ ◆Relation : NPO incurable disease network ◆page views : 20,000/month ◆active users：1,000/month ◆Patient Organization : 109 ● latest news : Collect and publish news related to rare diseases ● various types of rare diseases : designated rare diseases+rare cancers, pediatric chronic specific diseases ● clinical trial information : posting information about studies which are recruiting participants. ● event information : information on national events held by various organizations. ● Incurable disease medical liaison council・Posting information on updates of these organizations
『Approach : "Patient-centered / Digitizing" for Virtual clinical trial』
Planning with the University of Tokyo
Home visit clinical trial ’s with Physicians Development method reflecting patient opinion Introducing IOT for Patient Centricity Device delivery management（Japan's only mechanism） Recruitment Web contents for each disease / contents for IC support 『A specialized company that recruits subjects』 &つなぐ3H P-Guardian Patients Cancer Information Sites "oncolo" Wearable devices PHE-HER To view the data Family PC/Smartphone Remote second Opinion application Existing Zervis Oncole Use of accumulated data Al Algorithm Implementation Patient PHR Registry, Cooperation between PHR Servers and EHR Servers, etc. Cloud PHR Server Application to Clinical Trials Simplifying clinical trials Cost reduction EDC Serverい
3H In-Home Clinical trial Support Model for Japan 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 Completed Virtual Study for ONCOLOGY 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
*The actual number of sites we have made contracts as investigational site is over 300
1. Conduct Patients Feasibility in each country 2. Conduct cultural adaptive tactics in each country
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. 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+) 25
①By entering the progress information, you can share the information in real time basis ②The notification mail function allows you to know that information has posted on ipass+( patients has been introduced to sites by the contact center) ③CRC can access the call script answers given by the potential participants through the reader sheet. ※since the reader sheet contains personal information, it is available only to SMO staff. ④It is possible to exchange personal information of the candidates securely through ipass+(an account will be granted for each user) ＜Information that can be viewed＞ 【Sponsor/CRO】patient information（with no personal information）、progress 【for medical institutions】patient information（with personal information）、progress ＜viewable information＞ Content script of the call center After confirming the initial eligibility with the candidate the information will be posted on ipass+ institution/sponsor/ CRO Contact center
Copyright © 3H medi solution
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iPASS+ is a system to provide referrals information to the site 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 can log in to the iPASS+ with ID & password to view referral information.
3H Global Contact at:  imran@3h-ms.co.jp