• To be the preferred site in conducting clinical trial in Asia region.
• To conduct phase I, II, III clinical trial, bioavailability and bioequivalence studies in accordance to international standards, guidelines and protocol.
Clinical studies at CRW are closely controlled and monitored in the highest standard and with maximum safety measures to ensure adherance to international and local Good Clinical Research Practice standards. The CRW is one of the BABE sites which has been accredited by NPCB as being BA/BE compliance sties (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.
- Qualified Personnel
2.1 BLS and ALS trained clinical research physicians. 2.2 Qualified Clinical Trial Pharmacists. 2.3 Project manager. 2.4 QA/QC manager. 2.5 Well trained study coordinators. 2.6 GCP certified clincial research nurses.
- In-house State-of-the-art Equipment and Facilities
3.1 46 bedded in-patient ward. 3.2 Screening clin. 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 Temperature and relative humidity monitoring 24/7 in 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