【編集用】 2016 04 JP SRD Pamphlet

1 SRD GROUPSRD GROUP CRO SMO CRO SMO CRC IRB SRD SRD Support of Research and Development Group Profile I IV CRA CRC QA QC MedPlus1 Co., Ltd. SMO CRO I IV Group History1989 2 1992 3 1997 4 1999 3 ( ) SMO 2001 SMO SMONA 2003 SRD 100% SRD 2004 2 5 2005 SRD Support of Research and Development 2008 20 10 2009 5 2010 SRD 2011 SRD 2012 SRD 4800 2013 SRD SRD 25 15 2014 CSR 2015

2 MedPlus1 Co., Ltd. 3 CRO JCROA QA JSQA OPMA SMONA JMCA FIRM JACIC SMONA QA JSQA SRD JSOT JEMS MMS JSAAE QA JSQA Greetings & Company Profile 1989 Unmet Medical Needs CRO Support of Research and Development

3 Future 1989 3 1 5,000 216 2016 4 104-0032 3-4-8 RBM 2F TEL 03-5543-0296 FAX 03-5543-0184 E-mail URL CRO GCP Support of Research and Development Company Organization & Revenue

4 Revenue 2000200120022003200420052006200720082009 2010201120122013201420152016 (Estimates)Revenue5468221120110513231620 1450170016001175135017101920214020502390 2540# of Employees2532385070859712012410913016118 2187202216235050100150200250300050010001 500200025003000# of EmployeesRevenue 1,000,000 JPY Revenue# of Employees Project SystemProtocol(CTP)ReviewCommitteeProjec tManagerMedicalAdviserMedicalWritingDMBi o-statsQualityControlMonitoringLeaderSML CRAV enderStudySite CRA Data MVR CTP ICF CSR CTP DM CRF SAP QC MVR SRD CRA Sub-Monitoring Leader (SML), Monitoring Leader (ML)

5 Support of Research and Development SRD SRD PDCA Risk Based Monitoring & Management Project Management tool Monitoring manualOn-site monitoringCTP violation & Issue occurrenceCase analysisSolution set upInfo. sharingPlanDoCheckActIssue IdentificationRisk EvaluationSRD I. II. CRA III. I II CRF IV. V. SDV Service Description QC DM GCP I IV PMDA QC DM GCP CRO SMO * USA, EU.

6 AUS CRO Support of Research and Development 2015 4 QC DM GCP GCP QC DM GCP GCP CRO SMO ICH FDA EMA MR Experiences & Achievements CNS SRD SRD Support of Research and Development Skelton 25 Oncology; 24 Derma.

7 & Sensory Organ; 23 CNS; 12 Circulatory Organ; 6 Metabolism & Internal Secretion; 5 Immunology; 5 Respiratory; 4 Hematology; 4 Digestive Organ; 3 Gynecology; 2 Infectious Disease; 2 Others; 12 Organ; 23 Device Details# of SubjectsClassification*Extracorporeal circulation apparatus for familial hypercholesteremia40 IIIR ehabilitation system for lower back pain60 IIBleach agent for teeth62 IIIP otential therapy apparatus for shoulder stiffness20 IIContact lens40 IIIHome oxygen therapy apparatus for chronic cardiac insufficiency8 IILaser therapy apparatus for varicose vein90 IIIR ehabilitation system for upper limb with hemiparatic stroke patients40 IILaser therapy apparatus for benign prostatic hyperplasia95 IIIT hrombectomy catheter or acute ischemic cerebrovascular disease52 IVLaser therapy apparatus for varicose vein90 IIIA rtificial cardiac valve for a valvular disease of the heart50 IVMonopolar Radiofrequency system20 PMSD ental implant material20 IVExperiences &

8 Achievements ICF CRF IRB Support of Research and Development Number of ProtocolNumber of On-Site AuditIndicationScope of WorkDuration# of Subjects# of SitesArteriosclerosis obliteransMonitoring5 years7020 Chronic heart failureContracts and monitoring, year10015 Chronic heart failureContracts and monitoring, years20040 Rheumatoid arthritisTotal support5 years100025 Ulcerative colitisContracts, Patient registration, and monitoring, years20010 Treatment outcome study of medical deviceContracts, Survey collection, DM6 years3500230 Hyper-LDL-cholesterolemiaMonitoring3 months27020 OsteoporosisContracts, Patient registration, and monitoring, years1500150 AsthmaRetrospective (patient medical background) study2 years36030 CRA Sub-Monitoring Leader (SML), Monitoring Leader (ML) Project Manager SRD ClientCountryIndication/ Type of StudyA Pharm.

9 (US)JapanHemophilia / Phase IA Pharm. (US)JapanHemophilia / Phase IIIB Pharm. (US)JapanAlzheimer s Disease / Phase IIIC Pharm. (US)JapanRheumatoid Arthritis / Phase IID Pharm. (Germany)JapanAsthma / Phase IIID Pharm. (Germany)JapanAsthma / Phase III (Long)E Pharm. (Germany)JapanAtopic Dermatitis / HPA Axis Study + Phase II bF Pharm. (Japan)SingaporeDry Eye / Consultation of RecruitmentsG Pharm. (Japan)JapanPancreatic Cancer / Phase IIIH Pharm. (Japan)JapanSevere Atopic Dermatitis / Phase II bCRO (Swiss) with US Device CompanyJapanGynecology / PMS (Medical Device)010203020052006200720082009201020 1120122013201420152022111112122323201227 22101011123 Number of ProtocolNumber of On-Site AuditExperiences & AchievementsSupport of Research and Development CRO SMO 48 19 24 10 OTC 24 CRO IND IRB CRO CRO

10 BE 24 42 5 / 14 15 PMDA QMS SRD International ActivitiesCSIA SMO CRO 2015 CSIA Support of Research and DevelopmentClinical Development Support for Pharmaceuticals, Medical Devices, and Generic DrugsFirst SMO & CRO Alliance in ASIAFor Supporting Healthcare Company in the World Services CRA SMO CSIA ICH-GCP CSIA CTMS.