About CRC

Sunway Medical Centre’s Clinical Research Centre (SunMed-CRC) commenced in August 2009 in response to the demand for evidence-based practice as well as SunMed’s wish to participate significantly in medical research.  CRC is dedicated primarily towards  coordinating all research involving human subjects. Such research studies may be related to:

  • pharmaceutical products,
  • medical devices,
  • medical radiation and imaging,
  • surgical procedures,
  • medical records,
  • biological samples,
  • and/or epidemiological, social and psychological investigations.

CRC seeks to promote ethical and reliable clinical research according to the international and local Good Clinical Practice (GCP) standards. We bridge communication between investigators and their counterparts; and assist with feasibility assessments conducted by interested parties. Apart from facilitating SunMed to secure research projects, we assist in documenting and tracking progress of the clinical researches conducted. In response to the demand for evidence-based clinical research, we seek to increase participation of SunMed and to contribute significantly to the health and research industry.

VISION

To be one of the leading research centres in the ASEAN region

MISSION

To set up a world class Clinical Research Centre for the conduct of Clinical Trials and Research in line with Good Clinical Practices for advancement of medicine and improvement of clinical outcomes.

We are committed:

  1. To act as a centralized coordinating body for all research activities in SMC.
  2. To promote quality research amongst consultants and staff in SMC.
  3. To provide research-related administrative and technical support and training to consultants and staff.
  4. To forge and strengthen research partnerships with Academia, Malaysian Ministry of Health, and Pharmaceutical and Research Organizations.

Services

Clinical Research Centre (CRC), established within Sunway Medical Centre, is essential to the conduct of clinical research initiated in SunMed and therefore the facilities and resources are made available to meet the needs of sponsors/contract research organization (CRO), investigators, and all subjects.  Such services include:

  • Feasibility Studies.
    CRC assists consultants to review feasibility of protocols received from pharmaceutical     companies or CROs, taking into consideration of the resources, patient pool, patient     indication, facilities and services required in conducting the study in an institution.
  • Ethics Review.
    We have an institutional committee, the Sunway Medical Centre Independent Research Ethics Committee (SREC) constituted of medical professionals and non-medical members, whose responsibility is to ensure the rights, safety and well-being of human subjects involved in a clinical trial. It is compulsory for all studies involving human subjects at SunMed to be reviewed and approved by SREC for conduct.
  • Legal Review.
    We have in-house legal advisor that review the provisions of the agreements involved.
  • Pre-Clinical Trial Organising and Planning.
    CRC reviews the trial design and procedures to ensure that SunMed has the expertise and facilities to conduct the relevant procedures. CRC liaises and discusses with relevant departments and consultants on the protocol procedures to ensure any concerns are dealt with efficiently.
  • Clinical Trial Operations.
    Managing key deliverable issues, personnel, data, finance and operational matters in line with hospital policies to meet sponsor/CRO’s, GCP and regulatory requirements.
  • Site initiation and closure.
    We provide venue for site initiation and closure. CRC ensures that all pre-initiation and     initiation procedures are performed accordingly to meet GCP and regulatory requirements.

CONTACT

Address SunMed Clinical Research Centre
F-03-02, Block F
Sunway Geo Avenue
Jalan Lagoon Selatan,
Bandar Sunway, 47500 Selangor
Tel. No. +603 8601 1079
Fax No. +603 8601 1069
Emails sunmed-crc@sunway.com.my
edwinbt@sunway.com.my

Active Clinical Trials

No. Study Title Targeted Patients Recruitment Status
1. A Randomized, Double-blind, Parallel group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (SAMSON-II) Patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer Recruiting
2. A randomized, double blind, double-dummy, placebo controleed, 3-arm, parallel group study in pediatric subjects aged 10 through 17 to evaluate the efficacy and safety of BG00012 and BIIB017 for the treatment of relapsing-remitting multiple sclerosis Patients with relapsing-remitting Multiple Sclerosis Recruiting
3. A prospective, multicentric, single arm study to evaluate the safety and efficacy of the unity-b biodegradable balloon-expandable biliary stent system in subjects with biliary strictures(“study”) Patients with Biliary Strictures Recruiting
4. Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer in Asia Patients with Advanced Breast Cancer Recruiting
5. An international observational study in emerging markets to estimate the burden of illness in adult atopic dermatitis patients Patients with Atopic Dermatitis Closed
6. A Two-year, Two-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing The Efficacy And Safety Of Brolucizumab Versus Aflibercept In Adult Patients With Visual Impairment Due To Diabetic Macular Edema Patients with Diabetic Macular Edema Closed

Completed Clinical Trials

No. Study Title Targeted Patients Study Status
1. An Asia Pacific non-randomized, open-label phase II study evaluating the safety and efficacy of FOLFIRI plus cetuximab (Erbitux) or FOLFOX plus cetuximab as first-line therapy in subjects with KRAS wild-type metastatic Colorectal cancer (APEC-Study) Patients with metastatic colorectal cancer Closed
2. Phase 3, Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis Patients with Rheumatoid Arthritis Closed
3. A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy Patients with Rheumatoid Arthritis Closed
4. A Phase 2, Randomized, Double-blind Assessment of Efficacy and Safety of PF-04171327 (1, 5, 10, 15 mg Dose, Daily) Compared to 5mg and 10mg Prednisone Daily and Placebo Daily in Subjects with Rheumatoid Arthritis over an 8 Week Period Followed by a 4 Week Period of Tapering of Study Drug Patients with Rheumatoid Arthritis Closed
5. A 24-Week Randomized, Open-Label, 3 parallel-group comparison of once and twice daily biphasic insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects in adequately controlled on sitagliptin and metformin Patients with Type 2 Diabetes Mellitus Closed
6. A 24 week randomised, open label, 3 parallel-group comparison of once and twice daily biphasic insulin aspart (BIAsp) 30 plus sitagliptin and twice daily BIAsp 30, all in combination with metformin in insulin naïve type 2 diabetic subjects inadequately controlled on sitagliptin and metformin. Patients with Type 2 Diabetes Mellitus Closed
7. Efficacy and safety of agomelatine (25 mg/day with blinded potential adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, versus venlafaxine XR (75 mg/day with blinded potential adjustment up to 225 mg/day), 2-arm parallel groups, international multicenter study Patient with Generalized Anxiety Disorder Closed
8. A randomized, phase ii, placebo controlled study of gdc-0068, an inhibitor to akt, in combination with fluoropyrimidine plus oxaliplatin in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma Closed
9. A Long-term, Open-label Follow-up Study of Tasocitinib (CP-690,550) For Treatment of Rheumatoid Arthritis Patients with Rheumatoid Arthritis Closed
10. A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of ischemic cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). Patients with Rheumatoid Arthritis Closed
11. A 24-month, phase IV,randomized,double masked, multicenter study of ranibizumab monotherapy or ranibizumab in combination with verteporfin photodynamic therapy on visual outcome in patients with symptomatic macular polypoidal choroidal vasculopathy Patients with symptomatic macular polypoidal choroidal vasculopathy Closed
12. An Observational Study on Prevalent Antihypertensive Prescription practices in private hospital in Malaysia: Excellence Patients with hypertension Closed

About SREC

The Sunway Medical Centre Independent Research Ethics Committee (SREC) is a committee established under the authority of Sunway Medical Centre Berhad (SunMed). It evaluates the ethical aspects of research in SunMed, ensuring that they are reliably conducted in accordance with both international and Malaysian standards of ‘Good Clinical Practice’ (GCP).

SREC holds as its primary responsibility the safe-guarding of the rights, safety, and well-being of all research subjects. As per GCP requirements, members of the SREC are drawn from medical and non-medical sectors to ensure sufficient objectivity and independence from SunMed clinicians undertaking the research. The Clinical Research Centre (CRC) is the Secretariat to SREC.

OBJECTIVES AND SCOPE

The Objective of SREC are to

  • protect the rights, safety, dignity and well being of the subjects of research
  • promote ethical principles in human research
  • provide special attention to research involving vulnerable subjects and use of genetic testing
  • facilitate ethical research through efficient and effective review processes
  • provide competent review and monitoring of human research projects whilst they are active
  • promote awareness of the ethical conduct of human research

SCOPE

The Scope of the SREC’s operations manual is applicable to all members of SREC and persons conducting research in SunMed. The scope also encompasses the following:

  • terms of reference of the SREC which include:
    • responsibilities,
    • membership requirements,
    • terms of appointment,
    • liability coverage,
    • conditions of appointment,
    • offices, quorum & meeting requirements,  
    • use of independent panel and
    • education of members.
  • procedure for  submitting an application to the SREC for
    • approval to conduct research projects or to make amendments to a previously SREC approved research,
    • Reviewing of applications by SREC,
    • decision-making and the communication of decisions of the SREC,
    • following up and monitoring of approved research,
    • SREC documentation and archiving.

SREC Members (Year 2020-2021)

Name Gender Earned Degree Primary Specialty Occupation Affiliation With SunMed
Dato’ Dr Chang Kian Meng (Chairperson) M MBBS,MRCP,FRCP,FRCPA (Haem) Scientific Consultant Haematologist Yes
Assoc. Prof. Dr. Quek Kia Fatt (Vice-Chairperson) M PhD, FRIPH Scientific Lecturer of Community Health, Jeffrey Cheah School of Medicine & Health Sciences No
Dr. Felix Yap Boon Bin M MD (UNIMAS) MRCP (UK) AdvMDerm (UKM) Scientific Consultant Dermatologist Yes
Mr Edwin Tan (Secretary) M BSc Scientific Senior Manager, CRC Yes
Dr Chow Yock Ping F PhD Scientific Senior Research Scientist Yes
Mr. Lau Ngee Boon M NA Non-scientific Business Manager No
Mr Tey Woei Hann M Legal Non-scientific Assistant Manager Legal Services Yes
Mr. Mah Seng Cheng M MCE Non-scientific Sales Manager No
Ms Wan Mun Yi F Pharmacy Scientific Assistant Manager, Pharmacy Yes
Dr Eni Juraida Bt. Abdul Rahman M MBBCH (Alexandria), M.MED in Paediatric (UKM) Scientific Consultant Paediatric Haematologist-Oncologist Yes
Dr. Naresh Govindarajanthran M MBBS (UKM), MS (UKM) Scientific General Surgery, Vascular Surgery Yes
Prof Dr Abhi Veerakumarasivam M PhD (Oncology & Genetics) Scientific Professor Department of Medical Sciences No
Shaniz Chan F BSc Non-scientific Senior Manager Yes

FORMS

Research Approval Application Form
Research Amendment Application Form    
Research Progress Report Form
Research Closure Report Form    

CHECKLIST

Research Approval Application Checklist    
Informed Consent Form and Written Subject Information Checklist           
Genetic Research Checklist

Note: All the forms and checklist are to be sent to you separately

CONTACT

Address SREC Secretariat
C/O SunMed Clinical Research Centre
F-03-02, Block F
Sunway Geo Avenue
Jalan Lagoon Selatan,
Bandar Sunway, 47500 Selangor
Tel. No. +603 8601 1079
Fax No. +603 8601 1069
Emails sunmed-crc@sunway.com.my
edwinbt@sunway.com.my

Useful Links

National Medical Research Registry (NMRR)
https://www.nmrr.gov.my/fwbPage.jsp?fwbPageId=PublicDirectoryOfResearchList&fwbAction=List

Clinical Research Centre – Ministry of Health Malaysia (CRC-MOH)
http://www.crc.gov.my/

Society of Clinical Research Professionals Malaysia (SCRPM)
http://scrpm.ucoz.com/

National Pharmaceutical Control Bureau (NPCB)
http://portal.bpfk.gov.my/

National Committee for Clinical Research (NCCR)
http://www.nccr.gov.my/

Association of Private Hospitals of Malaysia (APHM)
http://www.hospitals-malaysia.org/portal/index.asp

ClinicalTrials.gov – Registry of Clinical Trials in U.S. and around the world
http://clinicaltrials.gov/