CRC SGH Team
Heartiest congratulations to Clinical Research Centre (CRC) Sarawak General Hospital (SGH) for being the 1st facility in the country to be accredited under the Phase 1 Unit Accreditation Program by National Pharmaceutical Regulatory Agency (NPRA).
CRC SGH Phase 1 Unit is an integrated facility with its own ward, pharmacy, procedure room, sample processing facility, clinical laboratory and a human physiological system testing assessment area (human cardiac/respiratory and neurology assessment). The unit is listed under the NPRA Phase 1 Accreditation programme. CRC SGH has a multidisciplinary team of research professionals who are trained and experienced in all aspects of clinical trial conduct in various therapeutic areas. The facilities at the site include:
- a dedicated 10 HDU bedded ward with 2 ICU equipped beds;
- temperature monitored drug storage areas with restricted access;
- a sample-handling area with refrigerated centrifuge;
- refrigerators and freezers (all temperature monitored) for drug and sample storage;
- synchronized digital clock;
- a physiology laboratory with instruments for cardiac, lung respiratory and neurological system assessment;
- a core laboratory. The laboratory at CRC SGH is MS ISO/IEC 17025: 2017 accreditated to perform drug plasma concentration analysis from June 2019 onwards. The laboratory is also MS ISO 15189: 2014 accreditated for medical testing which includes hematology, coagulation, biochemistry and immunoassay tests from November 2019 onwards;
- a dedicated procedure room;
- a subject recreation area; and
- Wi-fi enabled remote access monitoring capability.
CRC SGH Phase 1 Unit is able to conduct:
- Early Phase Research in Human
- Proof of Concept Studies
- Single Ascending Dose & Multiple Ascending Dose
- Food/ Race/ Gender Effect Study
- Drug-Drug Interaction Study
- Food/ Nutraceuticals Study
In addition, CRC SGH is open to discuss other clinical studies that could potentially be conducted at the site.