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