SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER

Contact Us Seoul National University Bundang Hospital Clinical Trials Center 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-707, South Korea Tel : 82-31-787-3941~2 E-mail : [email protected] We appreciate your interest in our center.

SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER - -

Best quality and reliability for clinical trialsBest quality for and reliability industry-academia-research network Best for model conducting advanced for Best technology researches geriatric trials clinical for Global leading center · · · · · · · · scientific, and efficient clinical trials and efficient scientific, Vision Seoul National University Bundang Hospital Clinical Seoul National University Clinical Bundang Hospital state-of-the-art is an Center re Trials clinical academic with full-service operational of excellence center search en the best research provide aims to We capabilities. sponsors and participants for investigators, vironment Korea. hospital in general under the first digital Mission Mission and Vision patients for and treatment medical research Advancing state-of-the-arta providing through ethical, for center

BUNDANG HOSPITAL HOSPITAL BUNDANG CLINICAL TRIALS CENTER UNIVERSITY SEOUL NATIONAL SEOUL NATIONAL About Us About SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER Lab for Lab for Lab for Center for for Center for Center Research Center for Center Center for for Center Medical Device Experimental Research Experimental Research Convergence Research Convergence Experimental and Medical Research Medical Research Pharmaceutical Research Pharmaceutical Clinical Trial Clinical Trial Center Medical Device Research Medical Research Device Collaboration Center Collaboration Clinical Research Center Clinical Research Lab for Lab for Lab for Preclinical Research Center Research Preclinical Center for for Center for Center Human Research Protection Human Research Research Research Team Administration Research Center for Center Center for for Center Medical Device Experimental Research Experimental Research Convergence Research Convergence Experimental and Medical Research Medical Research Pharmaceutical Research Pharmaceutical Clinical Trial Clinical Trial Center Medical Device Research Medical Research Device Collaboration Center Collaboration Clinical Research Center Clinical Research Preclinical Research Center Research Preclinical Human Research Protection Human Research Research Research Team Administration Excellence Trial Support Trial Global Clinical Administration Global Center of Global Center Excellence Trial Support Trial Global Clinical Administration Global Center of Global Center Director at at Director Specimen Pharmacy Management Room President at SNUBH at President Biomedical Research Institute Biomedical Research Director at at Director Specimen Pharmacy Research Center for Center Director Management Room Pharmaceutial Pharmaceutial President at SNUBH at President Clinical Trial SupportClinical Trial Biomedical Research Institute Biomedical Research Room Research Center for Center Director Outpatient Pharmaceutial Pharmaceutial Research Ward Research Clinical Trial SupportClinical Trial Room Outpatient Research Ward Research & Steering Committee Steering Early Clinical Trial Research Consulting Research Clinical Trials Clinical Trials Center Organization Institute Research Biomedical Clinical Pharmacology & Steering Committee Steering Early Clinical Trial Research Consulting Research Clinical Pharmacology

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_06 _08 _11 _12 _06 _10 Health and Welfare of Korea Welfare Health and AAHRPP Accreditation Designated as agencyDesignated conduct enabling to Medical Device Clinical Trials Medical Device for Center Trial as Clinical Designated of Korea the MinistryWelfare by of Health and Agency Therapy as Gene Approved Biobank as Human Approved Trials Clinical Global for Site Prime as Quintiles Designated in Korea in of Excellence as Global Center Designated the Ministry by ofTrials Geriatric Early Clinical Approval & Designation Approval Trials as agency Clinical Designated Pharmaceutical Outpatient visits per dayOutpatient members Faculty Investigators 2013 2007 2010 2011 2012 2003 2004 2006 6,000 262 254

l l l E-IRB system 11_ Research Institute Research Preclinical Research Lab Research Preclinical Clinical Research Institute Clinical Research Global Center of Excellence Global Center 11_ Education and Research lab and Research Education 11_ Research Ward in SNUBH CTC Ward Research Institutional (IRB) Review Board 03_ Clinical Trial Center (SNUBH CTC) Center Trial Clinical 05_ 07_ Human Research Protection Center Protection Human Research 09_ Medical Research Collaboration Center Medical Collaboration Research 07_ Staff at SNUBH Staff CTC Beds Physicians Specialty clinic centers Constitution & Opening Constitution 02_ SNUBH CTC reorganized under Biomedical SNUBH CTC reorganized

03_ 1st Symposium to celebrate the designation as the designation celebrate to 1st Symposium Recruitment a Faculty as Clinical Pharmacologist Recruitment a Faculty

02_ 03_ Seoul Bundang Hospital (SNUBH) University National 21 1,381 659 8 First full digital general hospital in Korea hospital general full digital First North stage 7 hospital outside of America (HIMSS Analytics) First Open in March, 2003Open in March,

l History l l l l l SNUBH OverviewSNUBH l About Us About 03_ SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER

) ) ℃ ) ℃ ℃ - Research sample collection, separation, storage, storage, sample collection,- Research separation, clinic laboratory and delivery central the to (-70 - Deep freezers - Refrigerators (-20 - Refrigerators (4 - Refrigerators - Centrifuges (0.01g) - Balance - Thermometer - Hygrometer all equipments for and validation calibration - Annual annually calibrated device recording Temperature - PK support Main equipment Outpatient room Outpatient rooms Independent outpatient via MSRI Online reservation system EMR to equipped with access system monitoring Computerized RoomSpecimen Management Equipment management Equipment

- Infusion pumps - Emergency carts - Defibrillators Main equipment SPO2 BP, with ECG, systems monitoring - Patient system monitoring - Central monitors blood pressure - Non-invasive

Facilities access to the electronic medical to access of the main hospital records(EMR) - Consistent observation and accurate - Consistent report events on adverse with system monitoring - Computerized Systematic management for subjects for management Systematic of investigational administration - Correct study protocol to drugs according Research Ward Research BUNDANG HOSPITAL HOSPITAL BUNDANG CLINICAL TRIALS CENTER UNIVERSITY SEOUL NATIONAL SEOUL NATIONAL Facilities SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER ) ℃ ) ℃ ) ℃ ) ℃ - Annual calibration and validation for all equipments for and validation calibration - Annual facilityrecognition with fingerprint control - Access - Bio Safety Cabinets in clean room in clean Cabinets - Bio Safety (2-8 refrigerators - Pharmaceutical chambers (20-25 temperature - Constant - Cabinets for returned IP returned for - Cabinets pump - Repeater - Pharmaceutical freezers (≤-20 freezers - Pharmaceutical IP (15~25 for - Cabinets Quality control of Equipment Quality control Main equipment

- Preparation of IP with aseptic condition in clean room of IP with aseptic condition - Preparation subject to - Medication counseling forms and related IP accountability - Record - Management of Investigational Product - Management of Investigational filled and double-check- IP prescription Investigational product management Investigational Pharmacy BUNDANG HOSPITAL HOSPITAL BUNDANG CLINICAL TRIALS CENTER UNIVERSITY SEOUL NATIONAL SEOUL NATIONAL Facilities SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER Conference Room Conference staff clinical research Meeting for subjects for Orientation inspection and Audit system Videoconference Monitoring RoomMonitoring center in clinical Independent space EMR to equipped with access system monitoring Computerized via MSRI Online reservation system - Pharmacokinetics/Pharmacodynamics - Bioavailability/Bioequivalence PK: Elderly- Special Population consultation Strategy - Bridging

- Pharmacometrics; Modeling - Pharmacometrics; & Simulation - Exploratory IND study Study - First-in-Human interaction interaction/Drug - Food study QT Thorough - Focused on early clinical trials Focused drug of new development for and consultation research pharmacologic Clinical Service area Phase 1 Clinical Pharmacology Unit Pharmacology 1 Clinical Phase BUNDANG HOSPITAL HOSPITAL BUNDANG CLINICAL TRIALS CENTER UNIVERSITY SEOUL NATIONAL SEOUL NATIONAL Facilities SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER

12 34 16 63 2012 2012 1 16 41 12 71 2011 2011 2 Phase IV Phase 82 18 44 18

2010 2010 2 Phase III Phase 12 31 12 58 2009 2009 3 Phase II Phase 9 13 29 52 2008 2008 1 Phase I Phase Phase Phase Trials Specific-Clinical Clinical Trials in the last 5 years in Trials Clinical

BUNDANG HOSPITAL HOSPITAL BUNDANG CLINICAL TRIALS CENTER UNIVERSITY SEOUL NATIONAL SEOUL NATIONAL Clinical Trial Experiences Clinical Trial SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER

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1 Chief of CPR team Human 1 Nurse in charge potential subjectspotential information Provide on clinical trials to subjectspotential Receipt ofReceipt fromcomplaints subjects participating in clinical trials impor Promote tance of clinical research institutions to 1 Anesthesiologist Research Protection Research

- 3000 10:00 PM 08:00 AM at MICUat

3 Residents NIGHT TEAM Quality 1 Charge Nurse1 Charge Assurance Unit Assurance Quality Management on clinical trials on ClinicalAudit researchers IRB on Audit

- Affairs 3000 Training Regulatory 10:00 PM 08:00 AM Education &Education 3 Residents and internationally Support inresearchers withcompliance regulatory Researchers Administration IRB committee ofCheck on trend clinical trials locally 1 Dedicated DAY TEAM DAY Senior in CPR nurse IRB Office IRB review IRB meeting IRB SOP IRB committee IRB website fee IRB review 1 Nurse in charge 1 Anesthesiologist Improve the quality the trials. of clinical Improve SupportEmergency System HRPP (Human Research Protection Program) Protection Research HRPP (Human to: system Integrated IRB) and sponsors, (subjects, of the institutions researchers, of the components all Encompass of subjects participate to and welfare in clinical trials safety, right, the Protect 1 Chief of CPR team

1592 2012 1634 2011 Panel 4 Panel 1322 2010 902 2009 Committee HRPP Acting Panel 3 Panel 756 2008 IRB 598 2007 596 2006 Panel 2 Panel 236 2005 AAHRPP accreditation e-IRB (http://e-irb.snubh.org) system Established Protection(OHRP) Office to of Human Research Registered Department to of Health and Human Service(DHHS),Registered Wide Assurance Federal

120 2004 SNUBH

President at President Panel 1 Panel Human Research Protection Center Protection 12 2003 IRB protocol review (initial) review IRB protocol 15.3 days from initial submission to approval (expedited review) (expedited approval initial submission to from 15.3 days 4 panels (weekly4 meetings a month meeting) (full review) approval initial submission to from 41.8 days 2012 2012 2003 2005 2005

IRB (Institutional Board) Review Clinical Trial Support System Trial Clinical SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER AB SCIEX Triple Quad™ 6500 LC/MS/MS System Quad™ 6500 LC/MS/MS Triple AB SCIEX Preclinical and clinical imaging lab imaging and clinical Preclinical NanoPET/CT (small animal) system NanoSPECT/CT (small animal) system PET/CT (human) systems SPECT/CT (human) systems Optical Imaging system system Beta-microprobe system In microdialysis vivo system Autoradiography Analysis of conc. of IP or metabolites from body fluid from of IP or metabolites of conc. Analysis Waters Xevo TQ-S Mass Spectrometer TQ-S Xevo Waters HPLC/GC systems HPLC/GC LC/MS/MS NMR scanners Radio-TLC Gamma counters Beta-Counter lab Animal Lab animal facilities model production Animal systems and monitoring care Animal Nano-molecular chemistry lab Medicalcyclotron Hot cells modules F-18 synthetic modules C-11 synthetic Research forResearch Industrialization of Lab Personnel Research Research Support for Drug Development for Education Education and Training Preclinical Imaging Preclinical Technology Development Technology Preclinical molecular imaging Preclinical of and management Production animal models - - Cyclotron Image Analysis Image analysis/quantification interpretation Biological nologies develop Support radiotracer for ment Imaging protocols Production of radioisotopes Production tech of cyclotron Development Preclinical and clinical molecular imaging center established in center molecular imaging and clinical Preclinical solutions innovative provide to in Korea one center 2008 is only and development. discovery for drug using molecular imaging and academic companies bio pharmaceutical provides center The and serviceswith molecular imaging technologies centers research processes. development their drug for accelerating 82-31-787-2933 www.bioimaginglab.re.kr Tel: - -

Clinical Imaging Clinical

Nano-Molecular Chemistry Clinical molecular imaging and manage Subject enrollment ment candidates Development and synthesis of and synthesis Development -specific nano-moledisease/target probes cules and molecular imaging of drug and radiolabeling Synthesis

Preclinical and Clinical Molecular and Clinical Imaging Center Preclinical Clinical Trial Support System Trial Clinical Expertise in Geriatric Clinical Trials SEOUL NATIONAL BUNDANG HOSPITAL UNIVERSITY CLINICAL TRIALS CENTER

National Central Dementia Center

Preclinical/ Clinical Molecular Neuroscience Center Imaging Center International Center Leading A Mecca for the First Geriatric treatment of A state-of-the-art IT Geriatric Early Clinical Trials Center in Korea infrastructure geriatric diseases

SNUBH, research- oriented, with expertise in geriatric disease area, was designated as Global Center of Excellence in Early Clinical Trials (GREATS) by the Ministry of Health and Welfare in No- vember, 2012. SNUBH will be subsidized for continuous upgrades in infrastructure and manpower throughout the year 2017. GREATS under SNUBH CTC aims to create new business model enabling to place geriatric early clinical trials from global and local sponsors. Furthermore, the center will lead the way to grow/ strengthen capabilities of SNUBH CTC towards globalization. Guidelines & DATA for Geriatric Clinical Trials Large Population Distribution of CGA Systemic Clinical Trials Center in Elderly Clinical Trial Specialized in Geriatric Rapid Enrollment SIT in place via Capabilities in Diseases CRC Support Service for IIT MOU with Global Elderly partners

Comprehensive Geriatric Assessment