The new facility of Clinical Research Center Sarawak General Hospital (CRC SGH) was approved as an extension of the existing SGH in Kuching. The laying of the foundation stone commenced on 27 September 2007 by the Director General at that time, YBhg Tan Sri Dr Ismail Merican. The construction of the facility started on 15 January 2011 and completed on 10 July 2015. The new facility was handed over to end-user by the Secretary General of the Ministry of Health, YBhg. Datuk Dr. Chen Chaw Min on 19 July 2016.
CRC SGH started its operation from the new facility on 1 November 2016. Despite the new facility, CRC SGH will still keep the satellite site at Sarawak Heart Center which has a research ward that can accommodated up to 28 subjects for Bioavailability/Bioequivalence (BABE) studies. The new facility is expected to be operational at optimal capacity as a fully integrated clinical research platform by the fourth quarter of 2017. This facility will be a one-stop research facility to undertake both local and international clinical trials, especially for critical early phase clinical research (Phase 1 and 2), aiming for international accreditation for clinical, analytical, data handling and all other relevant aspects related to clinical trials.
The new CRC SGH building consists of 3 floors; clinical, administrative and archiving floors.
Facilities at the Clinical Floor (Level 4):
- 8 HDU beds, 2 ICU beds (with remote monitoring access)
- Physio Room equipped with each of the following instrument:
o Cardiopulmonary Exercise Test (CPET)
o Echocardiogram System
o Electroencephalogram System
o Stress Test Machine with Treadmill
o 24-hour Ambulatory Blood Pressure System
o Telemetry System
- Clinical/ Biochemistry Lab
- Clinical Dry Chemistry Analyzer with Ion Selective Electrode (ISE)
- Clinical Chemistry – Immunoassay Analyzer (RIA)
- Hematology Analyzer, 18Parameters/ 5PT DIF
- Coagulation Analyzer
- Urinalysis Particle Analyzer
- HbA1c Analyzer
- Blood Gas Analyser
- Platelet Reactivity Analyzer
- ESR Analyzer
- ELISA system
- Flow Cytometry
- Liquid chromatography tandem mass spectrometry (LC-MS/MS)
- High performance liquid chromatography-diode array detector (HPLC-UV)
- High performance liquid chromatography-fluorescence detector (HPLC-Fluorescence)
- Molecular complete with PCR equipment and Next Generation Sequencing (NGS
- Clinical/ Biochemistry Lab
There are also sufficient supporting equipment such as analytical balance, ultrapure water system, centrifuge, etc. to support the activities in the lab.
- 5 Clinics/Consultation Rooms
- Investigational Product Room with controlled access. Temperature monitored fridge also available for temperature sensitive investigational product (IP).
- Sample Processing Room for biosample handling and bioarchiving. All fridges (4oC) and freezers (-20oC and -80oC) are temperature controlled with continuous monitoring.
- Dedicated Pharmacy to supply medications to CRC ward and study subjects.
Facilities at Administrative Floor (Level 5):
- Meeting/ Conference Room with built-in projector
- Interview Rooms/ Small Discussion Rooms for research consultations
- Industry Hotdesk (provide a working space for monitoring visits, industry visitors etc.)
- Active Archive Room
- High speed Wi-Fi
Facilities at Archiving Floor (Level 6):
- Passive Archive for long term archiving after study closed out (water and fire proof)
- Clinical studies from Phase Ib to Phase IV (both medicines and devices)
- 28 bedded ward for BABE and studies of lower risk
- HDU and ICU ward for early phase studies from Phase IB and studies of higher risk
- Support industry sponsored research (ISR) and investigator initiated research (IIR) in terms of providing IP support, consultation room, usage of facilities in Physio Lab and bioarchiving. All fridges and freezers for IP and biosamples are temperature guarded.
- Support IIR for laboratory related services from clinical to molecular analysis
- Research Consultations: NMRR, biostatistics
- Conduct research related training:
- Good Clinical Practice (GCP) Certification Workshop
- Basic and Advanced Biostatistics Workshop
- Introduction to Clinical Research (ICR) Workshop
- Questionnaire Validation Workshop
- Instrument application and laboratory related workshop
In the near future, clinical studies and laboratory services will be available for Phase I to Phase IV (both medicines and devices). The CRC SGH laboratory will be a core lab for biosamples analysis in the region (estimated to obtain full accreditation for ISO 17025 and ISO 15189 in 2019)
Clinical Trials Strength at CRC SGH
The types of trial that can be conducted:
- Phases I to Phase IV ISR – (any discipline) as SGH is the only tertiary referral public hospital in Sarawak.
- Any IIR that requires support of CRC facilities
Medical and Clinical Research Team:
- CRC – 49 staff (2 specialists, 5 medical officers, 8 pharmacists, 20 research nurses, 3 PPKs, 9 research officers, 1 IT officer, 1 admin staff)
- CRM – 9 staff (2 assistant regional managers, 1 senior study coordinator, 3 study coordinator level 1 and 3 technical study coordinator – technically trained to support CRC SGH lab)
Studies conducted at CRC SGH between 2012-2016