WhoWe Are

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

OrganizationChart

NAME	POSITION	QUALIFICATION	EMAIL
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
Cheah Kit Yee	Pharmacist	MPharm	cheahkityee@crc.moh.gov.my
Pang Lai Hui	Pharmacist	BPharm (Hons), UM	panglh@crc.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

Head, Centre for Clinical Trial (CCT)

Email: damenthi@moh.gov.my

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

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
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.

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.

Recent Publications

The VolREthics initiative to protect the well-being of healthy volunteers in biomedical research

Simultaneous Determination of Duloxetine and 4-Hydroxy Duloxetine Glucuronide in Human Plasma and Back-Conversion Study

Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses

Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results

Effect of an intensive patient educational programme on the quality of bowel preparation for colonoscopy: a single-blind randomised controlled trial

Clinical Pharmacologist

Email: sharonng@moh.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.