About

Overview

The Clinical Research Centre Sarawak General Hospital (CRC SGH) was established in 2003, as the third hospital CRC under the Ministry of Health (MoH) Clinical Research Centre network (now renamed as Institute for Clinical Research, ICR). Over the years, the centre has developed from administrative support for clinical research to executing most of the technical aspects.

In 2 March 2013, the first bioequivalence (BE) study was conducted at the newly established satellite site of CRC SGH at the Sarawak Heart Centre (SHC). These studies provide a platform for CRC SGH staff to be adequately trained and skilled to take on more complex clinical trials, in particular, early phase Clinical Trials.

CRC SGH became operational at the new CRC building at Sarawak General Hospital (SGH) from November 2016, which has a dedicated early phase clinical research ward, research laboratory and physiology laboratory facilities. The early phase research ward was inspected by the National Pharmaceutical Regulatory Agency (NPRA) in March 2019. CRC SGH became the FIRST site in Malaysia to successfully obtain the NPRA Phase 1 Accreditation in November 2019, and is approved to embark on First in Human (FiH) clinical trials in Malaysia. Adjacent to the ward is a dedicated investigational product storage and handling facility. 

The research laboratory comprises of standard laboratory, bioanalytical laboratory and molecular biology laboratory. The bioanalytical laboratory obtained MS ISO/IEC 17025: 2017 accreditation on 28 June 2019, and the standard laboratory obtained MS ISO 15189: 2014 accreditation for medical testing (not including molecular genetics) on 25 November 2019. CRC SGH research laboratory is the third laboratory in Malaysia to obtained dual MS ISO accreditation for chemical testing and medical testing; and the FIRST laboratory in MoH to do so. In January 2023, the CRC SGH research laboratory successfully added molecular genetics into the scope of testing under MS ISO 15189: 2014 accreditation.

The physiology laboratory at CRC SGH is fully equipped with clinical monitoring devices for the heart (i.e. HOLTER, ECHO, ambulatory BP monitoring), lung (i.e. CPET) and brain (i.e. EEG). The setup enables clinical trials to be conducted at one area within the vicinity of each other and patients do not need to travel between departments for essential clinical signs monitoring.

CRC SGH provides administrative backbone for clinical trials by offering research trainings, research consultation clinics, archiving support as well as space for monitoring visits. All these facilities and achievements enable CRC SGH to embark on complex and high impact clinical trials, particularly in the earlier phases of drug development.