The Clinical Research Ward (CRW) at Hospital Ampang is the first Phase I clinical facility established by the Ministry of Health to conduct various types of early phase clinical studies including first-in-man trials and bioavailability/bioequivalence (BA/BE) studies. The CRW began its operation in April 2011 and is currently managed by the hospital’s Clinical Research Centre (CRC). The facility’s main objective is to conduct phase I clinical trial in compliance with international standards and guidelines, as well as to develop and expand early phase clinical trials in the country. This facility has 46 beds and is located at level 7 of the hospital’s main building. Equipped with state-of-the-art medical facilities for phase I clinical research, the in-hospital location guarantees that every trial conducted is supported by 24/7 access to emergency response teams. Its operation is managed by a team of well-trained professionals including technical advisor, head of unit, project manager, pharmacists, study coordinators, clinical manager and clinical research nurses.
Facilities at Clinical Site
- 46-bedded inpatient ward
- Screening clinic
- • Sample processing room equipped with centrifuges, a laminar flow cabinet and freezer (-86°C, -80°C and -40°C)
- Clinical examination room
- Pharmacy room equipped with a pharmaceutical fridge (2-8°C)
- Fireproof documentation cabinets
- GPS-synchronized clocks in every room
- Recreational room (for trial participants)
- Prayer hall
- Internet access for patients
- Access control unit
Clinical studies at CRW are closely controlled and monitored to the highest standard and with maximum safety measures to ensure adherence to international and local Good Clinical Research Practice standards. The CRW is one out of 10 BA/BE sites (with an external bioanalytical site) which has been accredited by NPCB as being a BA/BE compliance site. Among the services provided by this facility include protocol development, ethics and regulatory submission, import license application, patient recruitment, clinical conduct and site project management.