Institute for Clinical Research Official Portal

WhoWe Are

Our Location

Hospital Ampang

- Tertiary hospital with 562 beds capacity
- National referral centre for haematology
- Medical, Emergency and ICU support
- Within Klang Valley - 25% of total population (~8.2mil)
- Highly accessible

Centre for Clinical Trial (CCT) was established in 2010 to conduct and support early and late phase clinical research in Malaysia. Besides early-phase clinical research, we also conduct bioavailability (BA) and bioequivalence (BE) studies for pharmaceutical industries in accordance with local and international standards. Our research facility, Clinical Research Ward (CRW) is located at Ampang Hospital, the largest referral centre for haemato-malignancies in Malaysia. Clinical studies conducted at CRW are closely managed and monitored to ensure adherence to international and local Good Clinical Practice standards. CRW was accredited by the National Pharmaceutical Regulatory Agency (NPRA) in 2014 as a BA/BE compliance site, in accordance with the Ministry of Health Malaysia Compliance Programme for Bioequivalence Centre.

 

Vision:

  • Being a Catalyst That Ensures Clinical Research Centers Conduct Ethical and Quality Clinical Research.

 

Mission:

  • To ensure the conduct of ethical and high-quality clinical research that contributes to the advancement of medical knowledge and benefits the patients.

 

Our Experiences:

  • Accredited Bioequivalence Centres in Bioequivalence Centre Compliance Programme, National Pharmaceutical Regulatory Agency (NPRA) 2014
  • First accredited standalone clinical trial site accredited by NPRA, 2017
  • First accredited Phase 1 Unit in Peninsular Malaysia by NPRA, 2022
  • Inspection for full accreditation of Phase 1 Unit planned on Apr 2024
  • First-in-Human trial on Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Bioavailability / Bioequivalence studies For US FDA, EMA, TGA, HSA, Taiwan FDA, NPRA submission
  • Food drug effect studies
  • Drug-drug interaction study
  • Phase 2 and 3 clinical trials
  • Inspection by NPRA
  • Audited by local and international companies
  • Data and safety monitoring board (DSMB) for other clinical trials

 

Over 10 years of dedication to Clinical Trial

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OrganizationChart

NAME
 
POSITION
 
QUALIFICATION
 
EMAIL
 
Dr. Damenthi Nair  Medical Officer (Head) MD (USU) damenthi@moh.gov.my 
Dr. Sharon Ng Shi Ming Medical Officer MBBS (MMMC), Msc Clinical Pharmacology (KCL) sharonng@moh.gov.my 
Chew Chun Keat Pharmacist BPharm (Hons), MClinResMeth chewchunkeat@moh.gov.my 
Chun Geok Ying Pharmacist MPharm, MBA (General) gychun@moh.gov.my 
Cheah Kit Yee Pharmacist MPharm cheahkityee@moh.gov.my 
Pang Lai Hui Pharmacist BPharm (Hons), UM panglh@moh.gov.my 
Lee Yi Lin Pharmacist MPharm (Hons), MMedSc leeyl@crc.moh.gov.my 
Zuhaida Asra Binti Ahmad Research Officer BSc (Hons) (Biotechnology), MSc (Cancer Research) zuhaida.asra@moh.gov.my 
SN Nurul Diyana Binti Mohd Sali Staff Nurse Diploma in Nursing diyana@crc.moh.gov.my 
SN Siti Halimah Binti Shahridzo Staff Nurse Diploma in Nursing ctlim.5775@gmail.com 

 

InvestigatorsHighlight

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Head, Centre for Clinical Trial (CCT)

Email: damenthi@crc.moh.gov.my  

MD

Areas of interest: Healthy Volunteer Research, First in Human Trials

Dr. Damenthi Nair is the Head of the Center for Clinical Trials (CCT) at Hospital Ampang. She has extensive experience in leading bioequivalence (BE) studies and has served as a principal investigator for various trials, including the Phase 1 Ravidasvir DNDi study. She has fostered partnerships with local and international companies for the execution of clinical trials, including involvement in Covid Vaccine Trials. Dr. Damenthi Nair is currently engaged in a collaborative effort to spearhead the development and implementation of Phase 1, 2, and 3 trials at Hospital Ampang.

Research Highlights

  1. FIH- Phase 1 study: An Open-Label, Multicenter, Intra-Subject Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Therapeutic Potential of BCX10013 in Subjects with Paroxysmal Nocturnal Hemoglobinuria
  2. An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Recent Investigator Sponsored Research

Study No: DNDi-OXA-07-HAT

Study Phase: Phase I (Drug-drug interactions)

Study Title: A single centre open-label, non-randomised, three-treatment, two-period, pharmacokinetic drug interaction study of single oral dose of acoziborole with sequential co-administration of midazolam and dextromethorphan in healthy male participants

Study No: DNDi-SOF/RDV-01-HCV

Study Phase: Phase II/III

Study Title: Open label phase II/III, multicenter, trial to assess the efficacy, safety, tolerance, and pharmacokinetics of sofosbuvir plus ravidasvir in HCV (+/- HIV) chronically infected adults with no or compensated cirrhosis in Thailand and Malaysia

Study No: 20200404 (IMBCAMS)

Study Phase: Phase III

Study Title: Randomized, Double -Blinded, Placebo Controlled Phase III Clinical Trial for the Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Healthy Population Aged 18 Years and Above in Malaysia

Study No: Cansino Bio Vaccine Trial CT 2022-01

Study Phase: Phase III (Non-Inferiority Trial)

Study Title: Immunogenicity, Efficacy and Safety of Inhaled (IH) viral vectored vaccine (Convidecia, CanSino) as second booster dose against emerging Variants of Concern (VOC) of SARS-CoV-2 to prevent breakthrough infections. A randomized observer-blind controlled trial.

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Technical Head, Centre for Clinical Trial (CCT)

Email: chewchunkeat@moh.gov.my

Master in Clinical Research Methods (MCRM), Bachelor of Pharmacy (Honour) [BPharm (Hon)], Diploma in Computer Science

Areas of interest: Early phase clinical trials, bioavailability/bioequivalence studies, study methodology, pharmacovigilance, bioethics.

Chew Chun Keat (CK), is the Technical Head of Centre for Clinical Trial. He is a pharmacist with a Master in Clinical Research Methods from Monash University and a Diploma in Computer Studies. He trained in phase 1 clinical trials in the UK and India and helped develop a Phase 1 Clinical Trial Unit at Hospital Ampang. The unit has conducted many pharmacokinetic/pharmacodynamic studies determining bioavailability of study compound, drug-drug interaction, food drug effect, drug formulation effect, bioequivalence studies, first-in-patient and vaccine trials. He has established the National Healthy Research Volunteers Register (NHRVR). CK has contributed to several Malaysian clinical trial guidelines. He is a board member of the Medical Research and Ethics Committee since 2015

Research Highlights

We are part of the WHO Solidarity Trial where it is a major international clinical trial involving 52 countries to evaluate COVID-19 treatments. Initially testing remdesivir, hydroxychloroquine, lopinavir/ritonavir, and lopinavir/ritonavir with interferon beta-1a, the trial uses an adaptive design for flexibility. Interim results in October 2020 showed these treatments did not significantly reduce mortality or ventilation needs in hospitalized patients. The trial's large scale and rapid data generation have been crucial in informing global health policies and treatment guidelines. It continues to evaluate new therapies, demonstrating the power of global collaboration in addressing the pandemic.

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Clinical Pharmacologist

Email: sharonng@crc.gov.my

MBBS (MMMC), MSc Clinical Pharmacology (KCL) 

Areas of interest: Healthy volunteer research, first-in-human trials

Awards and achievements:

  • CRM Sponsored Research Award for “Top Recruiter” 2023

Dr. Sharon Ng is a highly experienced principal investigator who specializes in conducting research on healthy volunteers. She completed her qualification as a clinical pharmacologist at Kings College London with distinction and has experience in First-In-Human trials. In the year 2023, she completed two notable clinical trials, namely the Drugs for Neglected Diseases initiative (DNDi) drug-drug interactions study that housed subjects for 21 days and a multicentre clinical trial evaluating the safety and efficacy of Convidecia AirTM, the first inhalation COVID-19 vaccine in the world. Her outstanding work in the latter trial won her the 2023 Clinical Research Malaysia Sponsored Research Award under the Top Recruiter category. She attributes her success to her team in Hospital Ampang who played a fundamental in conducting the clinical trials.

Services at Centre for Clinical Trial

Clinical Research Ward

  1. Protocol development.
  2. Informed consent documents development.
  3. Case report form design.
  4. Ethics submission.
  5. Regulatory submission.
  6. Volunteer recruitment (Health volunteers and patients).
  7. Clinical conduct.
  8. Project management.
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Phase 1 Ward

Phase 1 Ward

 

  • 10 beds equipped with central monitoring system

  • Remote monitoring assess (CCTV monitored)

BE Ward Area

 

  • 4 open bay with total of 36 beds

BE Ward Area

Screening Room

 

  • 2 rooms for informed consent taking and screening procedures

Screening Room

Recreational Room

Recreational Room

 

  • A space for volunteers to relax

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Research Highlights

DNDi-OXA-07-HAT
DNDi-SOF/RDV-01-HCV
20200404 (IMBCAMS)
Cansino Bio Vaccine Trial CT 2022-01

CLINICAL TRIAL EXPERIENCES

Completed Industry Sponsored Trials by CCT team from 2012 to 2023

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Meet Our Collaborators

HOVID
YSP
Mepharm
STADA
AMNEAL
biocryst
WHO
Veeda Clinical Research
Inserm
UM
DNDi
CanSinoBIO
BIOXIS
CRM
INFO KINETICS
CSI Medical Research
Altus Solutions
MOSTI
Regalia
CROWN
myXMO
Questra
CLINDATA
World Courier
Innosignum
Innoquest
Novotech

Centre for Clinical Trial (CCT)

Clinical Research Ward,
Level 7, Hospital Ampang
Jalan Mewah Utara,
Pandan Mewah
68000 Ampang, Selangor

Main Phone: +603-42896558 | Fax: 03-42801409
Email: ctuampang@moh.gov.my

 

 

Client 1
ICR
National Institutes of Health (NIH)
Ministry of Health Malaysia
Institute For Clinical Research
Block B4, National Institutes of Health (NIH)
No.1, Jalan Setia Murni U13/52, Seksyen U13
40170 Shah Alam, Selangor Darul Ehsan
Malaysia
 
Phone: 603-3362 7700
Email: contact@crc.gov.my
 

NIH Official Portal

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