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Singapore Clinical Research Institute
CHEUNG Yin Bun PhD CStatChief Scientific Officer
SCRI Overview
What is SCRI’s focus?To IMPROVE PATIENT CARE through innovative clinical research
To develop SCIENTIFIC LEADERSHIP in Singapore and ASEAN sub – regions in the execution of clinical research
To provide a FULL RANGE of CLINICAL RESEARCH EXPERTISE to academic, government agencies and industry
To coordinate MULTI SITE, MULTI NATIONAL NETWORKS for interaction, scientific excellence and enhanced clinical research execution
To facilitate and coordinate SCIENTIFIC COLLABORATION for Research Innovation
Geographic Coverage
Singapore 25 Studies
Thailand 4 Studies
Hong Kong2 Studies
China3 Studies
South Korea4 StudiesTaiwan
2 Studies
New Zealand1 Study
Indonesia3 Studies
Myanmar2 Studies
South Africa1 Study
Malaysia6 Studies
Brunei1 Study
Cuba1 Study
Saudi Arabia1 Study
India2 Studies
Pakistan3 Studies
Philippines 5 Studies
• 27 studies are currently supported
• 15 Singapore sites
• 59 Overseas sites
Bangladesh1 Study
Israel1 Study
Sri Lankan1 Study
Vietnam1 Study
Australia1 Study
SCRI’s ExpertiseResearch Methodology
Project Management
Data Management
Site Monitoring
Evidence Synthesis
Statistical Analysis
Network Management
Information Resource
SCRI’s expertise ranges from a single offering to the full suite required for your clinical needs
Where is SCRI today?52 People ……… 7 MDs; 11 PhDs
24 active studies; 12 multi site; 8 international; 4 locals
Study Design
Protocol Development
Study Management
Analyses
PublicationsSecondary analyses
Training & Education
Biostatisticians…. Epidemiologists…Project Managers…Data Managers…Site Monitors…..Network Managers…..IT Experts….. Administrators
32 articles and 1 book published in 2010
Biostatistics• To support the design and analysis of clinical trials and epidemiological
studies• To develop statistical methods relevant to the improvement of clinical
research
Expertise
• Protocol development and research grant application
• Experimental / survey design• Randomization / sampling schemes• Sample size estimation• Interim analyses• Statistical analyses• Psychometrics• Statistical reports and scientific manuscripts
Head of Department:
CHEUNG Yin Bun, PhD CStatProfessor, Duke-NUS, Singapore;
Adjunct Professor, University of Tampere, Finland
• 1 Senior Biostatistician
• 6 Biostatisticians (5 PhD, 1 MSc)
• 1 Research Assistant (1 RN)
Others:
Visiting consultants
Prof. Chow Shein-Chung
Dr. John Allen
Epidemiology
• To support the design and analysis of clinical trials and
epidemiology studies
• To develop statistical methods relevant to the improvement of
clinical research
Expertise
- Epidemiology- Evidence synthesis- Clinical Practice Guideline development- Research methodology training- Cochrane systematic review training- Critical appraisal of research literature
Head of Department:
Edwin Chan Shih Yen BVMS(Hons), PhDAdjunct Associate Professor, Duke-NUS Graduate Medical School, Singapore Director, Singapore Branch Australasian Cochrane Centre
• 3 Biostatisticians (3 PhD)• 2 Clinical Epidemiologists (1 MBBS, 1 MSc)
Research Operations: Conducting IITs to Industry standards
Head of Department:FENG Ying Ying, Mabel, BSc Applied Biology/Biotechnology
• 1 Senior Project Manager (1 BSc in Biomedical Science) , • 3 Project Manager (1 BSc Biochemistry and Biology, 1
Masters in BA + Doctor of Medicine, 1 Bachelor of Nursing)
• 1 Lead Clinical Research Associate (Master of Business Administration + Bachelor in Pharmacy),
• 2 Senior Clinical Research Associate (2 Bachelor of Science in Nursing)
• 3 Clinical Research Associate (1 Bachelor of Applied Science (Psychology), 1 Diploma in Nursing, 1 BSc in Biomedical Science)
• 1 Research Operations Assistant
• Providing EFFECTIVE, EFFICIENT, HIGH QUALITY single and multisite project management
• Provide MONITORING of studies , GUIDANCE and SUPPORT on compliance regulatory to achieve good quality data
Data Management: Capturing Data to Industry Standards
• CRF design
• Database design
• Discrepancy management
• Oracle Clinical database to cater both paper based and electronic data capture
• MedDRA and WHO Drug Dictionary
Enhance
Head of Department:GAO Hong, MBBS, MD, CCDM
• 2 Data Managers (2 BSc + 1 CCDM)• 4 Data Management Associates (3 Bsc, 1 Dip)• 1 Research Operations Assistant
Expertise
Research Informatics: Conducting Research in the 21st Century
• To develop and customize information technology tools to facilitate the complex clinical research workflow
Expertise
• Oracle clinical with Remote Data CaptureFully validated EDC system for regulatory submission
• Redcap Simple and intuitive EDC system
• RandomizationFlexible, central system for multi centre trials
Head of Department:Damien HONG, BInfo Tech
• 2 Senior Systems Analysts• 2 Systems Analyst• 1 Contractor
Current CRN’sHead of Department:Enny Kiesworo Pharm, MHA, MSc
• 1 Network Manager (RN/MSc/CCRP;)• 3 Clinical Research Network Associates
(2 BSc in Biological Sciences; 1 BSc in Pharmacy)• 1 Administrative Executive (BSc)
DEMENTIA
NETWORK Family Medicine Research Network
Comparing CRO Costs
SCRI (NMRC Rates)
SCRI (Academic
Rates)
SCRI (Commercial
Rate)
CRO 1 CRO 2 CRO 3
CRA (per hour rates)
S$35.80 $66.94 S$94.83 S$197 S$174 S$187
PM (per hour rates)
$47.45 $94.50 S$133.88 S$331 S$297 S$222
CRF per page
S$3.95 $7.00 S$12.00 S$35.10 S$36.10 S$20.40
Quality of ServicePoor0%
Fair3%
Good21%
Very Good45%
Excellent31%
1. Excellent + V Good = 76%2. Good + Fair =24%3. Poor = 0%
SummaryThrough collaboration and coordination, SCRI is committed to:• Developing Capabilities, Infrastructure and
Scientific Leadership for clinical research execution In order to:
• Improve patient care• Enhance the quality and impact of clinical research• Increase the efficiency of clinical research
execution
• 2 day workshop developing competitive grant applications• Hands-on guidance• Best presentation of key elements• Review and discussion of proposal• Collaboration with SCRI quantitative expert to further develop proposal
NEXT WORKSHOP:
19 & 26 Aug 2011 (Fri) 9.00 am - 5.00 pm Biopolis
www.scri.edu.sg
Grant Enhancement Training
Contact Us
Singapore Clinical Research Institute Pte Ltd31 Biopolis Way, Nanos#02-01Singapore 138669
contact@scri.edu.sg www.scri.edu.sg
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