SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL …
10
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. S E O U L NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
Transcript of SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL …
Contact UsSeoul 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.
S E O U L NATIONAL UNIVERSITY BUNDA N G H O S P I TA LC L I N I C A L T R I A L S C E N T E R
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Mission and Vision
Seoul National University Bundang Hospital Clinical
Trials Center is an state-of-the-art academic clinical re-
search center of excellence with full-service operational
capabilities. We aims to provide the best research en-
vironment for investigators, sponsors and participants
under the first digital general hospital in Korea.
Mission
Advancing medical research and treatment for patients
through providing a state-of-the-art center for ethical,
scientific, and efficient clinical trials
Vision · Best quality and reliability for clinical trials
· Best model for industry-academia-research network
· Best technology for conducting advanced researches
· Global leading center for geriatric clinical trials
About Us
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
l Open in March, 2003
l First full digital general hospital in Korea
l First stage 7 hospital outside of North America (HIMSS Analytics)
l 1,381 Beds l 6,000 Outpatient visits per day
l 659 Physicians l 262 Faculty members
l 8 Specialty clinic centers l 254 Investigators
l 21 Staff at SNUBH CTC
03_Seoul National University Bundang Hospital (SNUBH)03_Education and Research lab
07_Institutional Review Board (IRB)
Designated as agency Pharmaceutical Clinical Trials_09
Designated as agency enabling to conduct Medical Device Clinical Trials_06
Designated as Clinical Trial Center for Medical Device by the Ministry of Health and Welfare of Korea_05
Approved as Gene Therapy Agency_06Approved as Human Biobank_08Designated as Quintiles Prime Site for Global Clinical Trials in Korea_10Designated as Global Center of Excellence in Geriatric Early Clinical Trials by the Ministry of Health and Welfare of Korea_11AAHRPP Accreditation_12
11_Clinical Research Institute
11_Preclinical Research Lab
02_Medical Research Collaboration Center07_Human Research Protection Center
09_Clinical Trial Center (SNUBH CTC)
03_SNUBH CTC reorganized under Biomedical Research Institute
03_Recruitment a Faculty as Clinical Pharmacologist05_Research Ward in SNUBH CTC
11_E-IRB system
02_1st Symposium to celebrate the designation as Global Center of Excellence
SNUBH Overview Organization
Biomedical Research Institute
Clinical Trials Center
President at SNUBH
Director at Biomedical Research Institute
Clinical Trial Center
Center for Pharmaceutical Research
Center for Medical Device Research
Experimental and Clinical Research Center
Lab for Experimental Research
Lab for Convergence Research
Preclinical Research Center
Center forHuman Research Protection
Medical Research Collaboration Center
Research Administration Team
Director
Center forPharmaceutial
Research
Steering Committee
Center for Medical Device
Research
Clinical Trial Support Global Center of ExcellenceClinical Pharmacology
Research Ward Pharmacy
OutpatientRoom
Early Clinical Trial&
Research ConsultingSpecimen
Management Room
Administration
Global ClinicalTrial Support
President at SNUBH
Director at Biomedical Research Institute
Clinical Trial Center
Center for Pharmaceutical Research
Center for Medical Device Research
Experimental and Clinical Research Center
Lab for Experimental Research
Lab for Convergence Research
Preclinical Research Center
Center forHuman Research Protection
Medical Research Collaboration Center
Research Administration Team
Director
Center forPharmaceutial
Research
Steering Committee
Center for Medical Device
Research
Clinical Trial Support Global Center of ExcellenceClinical Pharmacology
Research Ward Pharmacy
OutpatientRoom
Early Clinical Trial&
Research ConsultingSpecimen
Management Room
Administration
Global ClinicalTrial Support
HistoryConstitution & Opening Approval & Designation
About Us
2003
2004
2006
2007
2010
2011
2012
2013
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Systematic management for subjects- Correct administration of investigational drugs according to study protocol - Consistent observation and accurate report on adverse events- Computerized monitoring system with access to the electronic medical records(EMR) of the main hospital
Independent outpatient roomsOnline reservation system via MSRIComputerized monitoring system equipped with access to EMR
Research Ward
Outpatient room
PK support- Research sample collection, separation, storage, and delivery to the central clinic laboratory
Main equipment- Deep freezers (-70 ℃) - Refrigerators (-20 ℃) - Refrigerators (4 ℃) - Centrifuges- Balance (0.01g) - Thermometer- Hygrometer
Equipment management- Annual calibration and validation for all equipments- Temperature recording device annually calibrated
Specimen Management Room
FacilitiesFacilities
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
Main equipment- Patient monitoring systems with ECG, BP, SPO2- Central monitoring system - Non-invasive blood pressure monitors - Infusion pumps - Emergency carts- Defibrillators
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Investigational product management- Management of Investigational Product- IP prescription filled and double-check- Preparation of IP with aseptic condition in clean room- Medication counseling to subject- Record IP accountability and related forms
Main equipment- Bio Safety Cabinets in clean room- Pharmaceutical refrigerators (2-8 ℃)- Constant temperature chambers (20-25 ℃)- Pharmaceutical freezers (≤-20 ℃)- Cabinets for IP (15~25 ℃)- Cabinets for returned IP- Repeater pump
Quality control of Equipment- Annual calibration and validation for all equipments- Access control facility with fingerprint recognition
Pharmacy
Facilities
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Focused on early clinical trialsClinical pharmacologic research and consultation for development of new drugService area
- First-in-Human Study - Pharmacokinetics/Pharmacodynamics- Food interaction/Drug interaction - Bioavailability/Bioequivalence- Thorough QT study - Special Population PK: Elderly - Pharmacometrics; Modeling & Simulation - Bridging Strategy consultation- Exploratory IND study
Phase 1 Clinical Pharmacology Unit
Facilities
Independent space in clinical centerComputerized monitoring system equipped with access to EMR Online reservation system via MSRI
Monitoring Room
Meeting for clinical research staffOrientation for subjects Audit and inspection Videoconference system
Conference Room
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER2008
2008
2009
2009
2010
2010
2011
2011
2012
2012
Clinical Trials in the last 5 years
Phase Specific-Clinical Trials
Clinical Trial Experiences
Phase I Phase II Phase III Phase IV
52
1312
18
1612
2931
4441 34
91 3 2 2 112 18 12 16
58
82
7163
SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL CLINICAL TRIALS CENTER
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Panel 2 Panel 3 Panel 4Panel 1
Clinical Trial Support System
2003 Established2005 Registered to Office of Human Research Protection(OHRP) 2005 Registered to Department of Health and Human Service(DHHS), Federal Wide Assurance2012 AAHRPP accreditation2012 e-IRB system (http://e-irb.snubh.org)
4 panels 4 meetings a month (weekly meeting)41.8 days from initial submission to approval (full review)15.3 days from initial submission to approval (expedited review)
IRB (Institutional Review Board)
IRB protocol review (initial)
IRB
Human Research Protection Center HRPP Acting
Committee
President at SNUBH
12120
236
596 598
756
902
1322
16341592
IRB Office
Check on trend of clinical trials locally and internationally
Support researchers in compliance with regulatory
Education & Training
Regulatory Affairs
QualityAssurance Unit
HumanResearch Protection
IRB review
IRB meeting
IRB SOP
IRB committee
IRB website
IRB review fee
Researchers
Administration
IRB committee
Quality Management on clinical trials
Audit on Clinical researchers
Audit on IRB
Receipt of complaints from subjects participating in clinical trials
Promote impor-tance of clinical research institutions to potential subjects
Provide information on clinical trials to potential subjects
Encompass all of the components of the institutions (subjects, researchers, and sponsors, IRB) Protect the right, safety, and welfare of subjects to participate in clinical trialsImprove the quality of clinical trials.
HRPP (Human Research Protection Program)
Emergency System Support
Integrated system to:
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
1 Chief of CPR team 1 Chief of CPR team
1 Nurse in charge
1 Anesthesiologist
1 Nurse in charge
1 Anesthesiologist
1 DedicatedSenior nurse in CPR
1 Charge Nurse at MICU
3 Residents 3 Residents
DAY TEAM 08:00 AM
- 10:00 PM
3000
NIGHT TEAM 10:00 PM
- 08:00 AM
3000
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
Clinical Trial Support SystemPreclinical and Clinical Molecular Imaging Center
Development and synthesis of disease/target -specific nano-mole-cules and molecular imaging probes
Synthesis and radiolabeling of drug candidates
Clinical molecular imaging
Subject enrollment and manage-ment
Production of radioisotopes
Development of cyclotron tech-nologies
Support for radiotracer develop-ment
Imaging protocols
Image analysis/quantification
Biological interpretation
Preclinical and clinical molecular imaging center established in 2008 is only one center in Korea to provide innovative solutions using molecular imaging for drug discovery and development. The center provides bio pharmaceutical companies and academic research centers with molecular imaging technologies and services for accelerating their drug development processes.
Tel: 82-31-787-2933 www.bioimaginglab.re.kr
Nano-Molecular Chemistry
Clinical Imaging
Preclinical molecular imaging
Production and management of animal models
Preclinical ImagingCyclotron
Image Analysis Research for Technology Development
Research Support for Drug Development
Education and Training of Lab Personnel
Industrialization
Medical cyclotronHot cellsF-18 synthetic modulesC-11 synthetic modulesHPLC/GC systemsLC/MS/MSNMRRadio-TLC scannersGamma countersBeta-Counter
NanoPET/CT system (small animal)NanoSPECT/CT system (small animal)PET/CT systems (human)SPECT/CT systems (human)Optical Imaging systemBeta-microprobe systemIn vivo microdialysis systemAutoradiography system
Lab animal facilitiesAnimal model productionAnimal care and monitoring systems
Nano-molecular chemistry lab Preclinical and clinical imaging lab
Animal lab
Waters Xevo TQ-S Mass Spectrometer AB SCIEX Triple Quad™ 6500 LC/MS/MS System
Analysis of conc. of IP or metabolites from body fluid
Expertise in Geriatric Clinical Trials
International Center LeadingGeriatric Early Clinical Trials
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.
First Geriatric Center in Korea
Preclinical/Clinical Molecular
Imaging CenterNeuroscience Center
A state-of-the-art IT infrastructure
National Central Dementia Center
Guidelines & DATA for Geriatric Clinical Trials
Distribution of CGA Systemic Clinical Trials Center in Elderly
CRC Support Service for IIT
SIT in place via MOU with Global partners
Large Population
Comprehensive Geriatric Assessment
Rapid Enrollment Specialized in Geriatric Diseases
A Mecca for the treatment of
geriatric diseases
Clinical Trial Capabilities in
Elderly
SEOU
L NATIO
NAL U
NIVERSITY BU
ND
ANG
HO
SPITAL CLINICAL TRIALS CEN
TER
