First Facility in Malaysia Accredited under the Phase 1 Unit Accreditation Program by National Pharmaceutical Regulatory Agency

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 
  • ADME 
  • 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.