Clinical Trial Unit (CTU) was established in 2010 to conduct and support early and late phase clinical research in Malaysia. Besides early phase clinical research, we also conduct bioavailability and bioequivalence studies for pharmaceutical industries in accordance to local and international standards.
Our research facility, Clinical Research Ward (CRW) is located at Ampang Hospital, the largest referral centre for hemato-malignancies in Malaysia. Clinical studies conducted at CRW are closely managed and monitored to ensure adherence to international and local Good Clinical Practice standards. CRW has been accredited by National Pharmaceutical Regulatory Agency (NPRA) in 2014 as a BABE compliance site according to Ministry of Health Malaysia Compliance Programme for Bioequivalence Centre. (http://portal.bpfk.gov.my/be-studies-centre)
1.1 Protocol development. 1.2 Informed consent documents development. 1.3 Case report form design. 1.4 Ethics submission. 1.5 Regulatory submission. 1.6 Volunteer recruitment (Health volunteers and patients). 1.7 Clinical conduct. 1.8 Project management.
- Inhouse Qualified Personnel with GCP certification
2.1 BLS and ALS trained investigators. 2.2 Clinical Trial Pharmacists. 2.3 Project manager. 2.4 QA/QC manager. 2.5 Well trained study coordinators. 2.6 Well trained clinical research nurses.
- State of the art Facilities
3.1 Research ward with 46 beds. 3.2 Screening clinic. 3.3 Sample processing room with refrigerated centrifuges, and deep freezers (-80 oC, -20 oC). 3.4 Pharmacy with humidity chamber and fridge. 3.5 Documentation room with fire proof cabinet. 3.6 GPS synchronized clocks located at strategic are. 3.7 Recreational room (for trial participants). 3.8 Prayer room. 3.9 All day temperature and relative humidity monitoring at critical areas and equipment. 3.10 Access controll in restrictive areas. 3.11 Closed-circuit TV surveilance.
Dr Damenthi Nair
Clinical Research Ward,
Clinical Trial Unit
Level 7, Hospital Ampang
Jalan Mewah Utara,
68000 Ampang, Selangor
Tel: 03-4289 6558