Clinical Research Ward (CRW), Hospital Ampang was established in 2010 as a collaborative unit between a global contract research organization, named Veeda Clinical Research and the National Clinical Research Centre (NCRC), Ministry of Health. To embrace the collaboration, the facility was initially named as CRC-Veeda-Malaysia (CVM). The primary objective of the collaboration was to spearhead the development of early phase clinical research in Malaysia and to prepare a local team for conducting early phase clinical studies. More importantly, the collaboration provides a gateway to bring forward our local drug development from non-human phase to early phase clinical research.
Moving forward, CRW is now a fully established research facility under the governance of Clinical Trial Unit (CTU) of NCRC. The research facility is now operated by a research team of medical officers, pharmacists, nurses and science officers. The CRW team has completed more than 15 bioequivalence studies, one intensive pharmacokinetic investigation for a DNDIstudy in hepatitis C and one multicenter retrospective study in anemia aplastic till 2016. Besides, the CRW team is also supporting the conduct of many investigator initiated researches (IIR) by offering expertise and consultation in study design, statistical analysis, data management, study drug management and project management.
Drugs for Neglected Diseases Initiative (DNDI)
Research operations at CRW are governed by over 100 different standard operating standards (SOPs), covering areas such as project management, clinical operation, subject recruitment, pharmacy, quality assurance, quality control and so on. The SOPs are improvised based on current operational needs and standards from time to time, to ensure sustainability in operational quality.
Facilities at Clinical Site
- 46 research beds
- Cardiac monitors
- Ultralow freezers
- 2 screening rooms
- Documentation room
- Pharmacy room
- Sample processing room
- Recreational room
- GPS-synchronized clocks
- Internet access for patients
Essential equipment and rooms are monitored through a third party monitoring system, which helps notify the investigators of unexpected temperature and humidity excursions.
The CRW is one out of 10 Bioavailability/Bioequivalence (BA/BE) sites (with an external bioanalytical site) which has been accredited by the National Pharmaceutical Regulatory Authority as being a BA/BE compliance site.
The creation of CRW as a platform to conduct early phase clinical studies is in line with the vision and mission of NCRC to become a leading clinical research organization in Asia, to improve patients’ health outcomes through ethical and quality clinical research and to attract biotechnology companies and contract research organizations to conduct clinical research in Malaysia. Therefore, CRW strives to support NCRC and the nation by continuously expanding its capacity and expertise in early phase clinical research.