Clinical Research Centre

About Clinical Research Centre

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 the leading and pioneering centre of excellence in ASEAN region for research in a private hospital.

MISSION

To create a sustainable research ecosystem in Sunway Medical Centre by enabling medical staff and professionals to learn and discover with the goal to provide the best patient care.

GOAL

To set up a Clinical Research Centre (CRC) for the conduct of quality clinical trials and research according to Good Clinical Practice (GCP) for the advancement of medicine and to improve Quality of Life for the patients.

OBJECTIVES

Set up a strong governance structure within Clinical Research Centre (CRC) to facilitate communication, approval process and quality research conducts which benefits and improves the quality of life for the patients.
To set up comprehensive infrastructure and facilities to support research.
Foster strong research culture among consultants, allied healthcare partners and nursing staffs, and establish research identity.
Establish SunMed as partner of choice for research collaboration among CROs, Industry, Academia & Community.

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.

ORGANIZATION CHART

INDUSTRY SPONSORED RESEARCH (ISR)

Active Clinical Trials

The list of clinical trials that are currently active at Sunway Medical Centre. For those who are interested to participate in the current clinical trials, please contact us.

No.	Study Title	Targeted Patients	Recruitment Status
1.	A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 versus Best Available Therapy in Subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/μL)	Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia	Recruiting
2.	MANIFEST-2: A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI‑0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients	Patients with Myelofibrosis	Recruiting
3.	KontRASt-02: A Randomized, Controlled, Open-label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 versus Docetaxel in Previously Treated Subjects with Locally Advanced or Metastatic KRAS G12C Mutant Non-Small Cell Lung Cancer	Patients with non-small cell lung cancer	Recruiting
4.	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in addition to R-CHOP versus R-CHOP in Previously Untreated, High-Intermediate and High-risk Patients with Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)	Patients with newly-diagnosed diffuse large B-cell lymphoma	Recruiting
5.	A Phase III, Open-Label, Randomized Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab Administered via On Body Delivery System in Patients with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy (PALOMA-3)	Patients with Metastatic Non-Small Cell Lung Cancer (Stage 4)	Recruiting
6.	A Phase III, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants with Muscle-invasive Bladder Cancer	Patients with bladder cancer	Recruiting
7.	The ARiCa Study: Use of an online Asian Genetic Risk Calculator to improve the uptake of genetic counselling and genetic testing among breast cancer patients	Breast Cancer	Recruiting
8.	Phase II/III Multicenter, Randomized, Double-blind, Placebo-controlled Study in Patients with Warm Autoimmune Hemolytic Anemia (wAIHA) to Evaluate the Efficacy and Safety of an Intravenous Biologic Therapy, followed by an Open-label Extension Period	Autoimmune Hemolytic Anemia (wAIHA)	Initiating
9.	A Phase 3 Study Utilizing a Minimal Residual Disease Directed Approach to Evaluate the Combination of Amivantamaband Lazertinib versus Single Agent Osimertinib in the Adjuvant Treatment of Patients with Resected EGFR-Mutated Non-Small Cell Lung Cancer (Adonis)	Resected EGFR-Mutated Non-Small Cell Lung Cancer (Adonis)	Initiating
10.	CABL001J12302: Feasibility Survey for Asciminib in 1L CML A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase	Myelogenous Leukemia	Initiating
11.	Observational study to evaluate the actual use of Elidel in South and East Asian Patients from 3 months to 12 years with mild moderate atopic dermatitis	Mild moderate atopic dermatitis	Study awarded
12.	A Phase 3b, multicenter, randomized, double-blind, placebo-controlled, 3-arm study of guselkumab 100 mg administered subcutaneously (SC) at Weeks 0, 4, and q8w thereafter or 100 mg SC q4w through Week 48 in participants with active PSA who are biologic naïve and have had inadequate response to current standard therapies. Participants who have not discontinued will be eligible to enter a long-term extension (LTE)	Psoriatic arthritis	Initiating
13.	Randomized, double-blind, placebo-controlled, Phase IIb/Phase III study to evaluate the efficacy and safety of spesolimab in patients with moderate to severe hidradenitis suppurativa	Hidradenitis suppurativa	Initiating
14.	A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA)	Viral Lung Infection	Study awarded
15.	EvasayilTM : A placebo-controlled trial to evaluate the efficacy and safety of spesolimab in the treatment of patients with Netherton syndrome	Patients with Netherton syndrome	Initiating

INVESTIGATOR INITIATED RESEARCH (IIR)

RESEARCH OUTPUT

Top 5 most cited research output. For the full list of research outputs, please click the link here.

CRC Policies and Procedures

Policy number	Policy name	Applicability
SMC-SOS-CORP-CRC-001	Scope of Services	IIR
SMC-GL-CORP-CRC-001	Prepare for an Audit or Inspection	IIR
SMC-GL-CORP-CRC-002	External Grant Application for Investigator Initiated Research (IIR)	IIR
SMC-GL-CORP-CRC-003	Grand Management for Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-007	Request for Research collaboration with SunMed	IIR
SMC-SOP-CORP-CRC-008	SunMed Funding Application	IIR, IISR
SMC-SOP-CORP-CRC-009	Document Control for research Related Documents	ISR, IISR
SMC-SOP-CORP-CRC-010	Protocol Development	IISR (if applicable), IIR
SMC-SOP-CORP-CRC-013	Informed Consent Process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-016	Re-consent process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-017	Taking Informed Assent Process	IIR, IISR, ISR
SMC-SOP-CORP-CRC-019	Research Team Training	IIR, IISR, ISR
SMC-SOP-CORP-CRC-020	Handling of Research Noncompliance	IIR, ISR, IISR
SMC-SOP-CORP-CRC-021	Assisting in Site Initiation Visit for ISR	ISR
SMC-SOP-CORP-CRC-022	Assisting in (COV) for Industry Sponsored Research (ISR)	ISR
SMC-SOP-CORP-CRC-023	Assisting in Archiving in (ISR)	ISR
SMC-SOP-CORP-CRC-027	Safety Surveillance Management	ISR, IISR
SMC-SOP-CORP-CRC-028	Research Sample Management	ISR
SMC-SOP-CORP-CRC-029	Submitting Study Progress Report & End of Research Report	IIR
SMC-SOP-CORP-CRC-030	Laboratory Specimen Handling & Shipment in ISR	ISR
SMC-SOP-CORP-CRC-031	Investigational Product (IP) Management	ISR, IISR
SMC-SOP-CORP-CRC-032	Investigational Product (IP) Dispensing	ISR, IISR
SMC-SOP-CORP-CRC-033	Study Closeout for Investigator Initiated Research (IIR)	IISR (If applicable)
SMC-SOP-CORP-CRC-034	Site Initiation for Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-035	Maintaining Study Documentation & Record Keeping in Industry Sponsored Research	ISR, IISR
SMC-SOP-CORP-CRC-036	Monitoring of Investigator Initiated Research (IIR)	IIR
SMC-SOP-CORP-CRC-037	Handling Feasibility Studies	ISR
SMC-SOP-CORP-CRC-038	Research Misconduct	ISR, IISR, IIR
SMC-SOP-CORP-CRC-039	Pre -Publication Submission Review	IISR

Request for policies or Standard Operating Procedures, please write to: Head of Department, Clinical Research Centre at sunmed_crc@sunway.com.my .
SunMed employee may access CRC policies and procedures via shared point.
Applicant shall read through the relevant policies and procedures prior to the commencement of your research project.

About SunMed Independent Research Ethics Committee (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

Registered with National Pharmaceutical Regulatory Agency (NPRA)

Sunway Medical Centre Independent Research Ethics Committee (SREC) is one of the 3 private hospital among the 13 Ethics Committee Registered with Drug Control Activity (DCA)

Objective

The objectives of SREC are to

protect the rights, safety, dignity and wellbeing 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 Member (Term 2022-2023)

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
Mr. Edwin Tan (Secretary)	M	BSc	Scientific	Senior Manager, CRC	Yes
Ms. Azliana Binti Abu Bakar Sajak	F	BSc, MSC	Scientific	Research Scientist	Yes
Prof. Dr. Abhi Veerakumarasivam	M	PhD (Oncology & Genetics)	Scientific	Professor, Department of Medical Sciences	No
Mr. Lau Ngee Boon	M	NA	Non-scientific	Business Manager	No
Mr. Mah Seng Cheng	M	MCE	Non-scientific	Sales Manager	No
Dr. Felix Yap Boon Bin	M	MD (UNIMAS) MRCP (UK) AdvMDerm (UKM)	Scientific	Consultant Dermatologist	Yes
Ms. Wan Mun Yi	F	Pharmacy	Scientific	Assistant Manager, Pharmacy	Yes
Mr. Ashwin A/L Kumar	M	LL.B	Non-scientific	Senior Manager, Legal Services	Yes
Ms. Amy Khoo Leet Chien	F	LL.B	Non-scientific	Director, Legal Services	Yes
Dr. Jennifer Leong Siew Mooi	F	MBBS (IMU), MCO (UM)	Scientific	Consultant Clinical Oncologist	Yes
Dr. Thangesweran Ayakannu	M	MBBS (Trinidad, West Indies), MLiP (UK), DFFP (UK), MRCOG (UK), PhD (UK), Colposcopist (UK), Laparoscopic Pelvic Surgeon (UK), INTUITIVE Registered Gynaecological Robotic Surgeon (UK), British & Irish Association Registered Robotic Gynaecological Surgeon (UK)	Scientific	Consultant Obstetrics & Gynecology-Oncologist	Yes

SREC Meeting Dates and Application Submission Due Date

Please click here to download for 2023 SREC meeting dates and application due date. Applicant may also contact the SREC secretariat to confirm the SREC meeting dates and application due date.

Overview of Conducting Research in Sunway Medical Centre

All research projects to be conducted in SunMed MUST obtain research ethic committee and institutional approvals.

Ethics Application

Please refer to SREC Application Guidelines on how to apply:

SREC Form	Checklist
Research Approval Application Form	Research Approval Application Checklist
Research Amendment Application Form	Informed Consent Form & Written Subject Information Checklist
Serious Adverse Event Report Form	Genetic Research Checklist
Research Progress Report Form (SREC)
Research Closure Report Form

Institutional Approval

SunMed Research Request Form (SMRR) completion
Principal investigator is required to complete the SunMed Research Request Form (SMRR) and read the Sunway Anti Bribery and Corruption (ABC) policies together with related CRC policies and procedures. Attach proposal and all written information that you are providing to research subject.

Departmental Approval
Investigator has to approach the related department(s)’ Head for the approval(s). For instance, if your research involving nurses, then you are required to approach the Director of Nursing. If SunMed staff is the target subjects, then you should obtain the approval from Medical Director/Chief Executive Officer (CEO). If you are unsure which department to approach you may contact us.

Departmental Approval for SunMed
Sunway Medical Centre (SunMed) should be done via the link:- https://bit.ly/3ktQAwa

Submitting the SMRR form, Departmental Approval and a copy of your research proposal
Please submit the following to sunmed_crc@sunway.com.my :-
a) Signed and dated SMRR form
b) Signed and dated ABC declaration form (appendix of SMRR)
c) A copy of your recent research proposal with version and date
Kindly ensure all the documents are submitted to avoid delay of your research approval. Please take note that the department approval(s) is/are compulsory for feasibility assessment.

Institutional Approval
This will commence after the completion of feasibility assessment and scientific review. If the project is approved by Sunway CRC Research Board (SRB) the investigator will receive an institutional approval letter.
For Sunway Medical Velocity (SMCV), you are required to complete the Institutional Approval Form.
Research Agreement
Preparation and signing of collaborative research agreement
CRC will contact you if an agreement is required. We may provide the agreement template to the collaborator for review and comment. Once all parties agreed and signed the agreement then only the study could be initiated.

Research Reporting

i. Research Progress Report - Download Here
- Research under investigator initiated research initiated Research (IIR) is required to submit research report annually every 6 months

ii. End of Research (EOR) Report - Download Here
- Research under investigator initiated research initiated Research (IIR) is required to submit research report annually every 6 months

iii. Pre-publication Submission Review - Download Here

Send a copy of your drafted publication materials to sunmed_crc@sunway.com.my prior submission for publication. After publication a copy of the publication shall be submitted to delegated CRC staff. Furthermore, acknowledgement to Sunway Medical Centre is required for funded research. This applicable for any research project that conducted in Sunway Medical Centre.

Note: This ONLY applicable for research project conducted Sunway Medical Centre

Research Non-Compliance & Protocol Deviation Reporting

For Investigator Initiated Research (IIR) which does not involve investigational products (Clinical Trial), submit Research Noncompliance Form to CRC.

For Industry Sponsor Research (ISR) which involves investigational products (Clinical Trial), submit SREC Protocol Deviation Reporting Form.

Reporting Timeline - Minor within 30 days, Major within 7 days (calendar date).

Internship and Attachment

If you are interested to apply for attachment or internship at SunMed CRC, kindly send your application to wongsoy@sunway.com.my with the following documents:

A cover letter addressing to Head of Division, Clinical Research and Medical Education, Sunway Medical Centre
A copy of your resume

Operation hours

8.00 am - 5.30 pm

Inquiry

For any inquiry and feedback, please contact Clinical Research Center (CRC) at sunmed_crc@sunway.com.my.

Contact Us

Address	SunMed Clinical Research Centre, F-03-02, Block F, Sunway Geo Avenue, Jalan Lagoon Selatan, Bandar Sunway, 47500 Selangor
Tel No	+603 8601 1072 +603 8601 1079 +603 8601 1080
Fax No	+603 8601 1069
Email	sunmed_crc@sunway.com.my edwinbt@sunway.com.my