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China FDA Accredited Research Specialties in CUHK/ PWH
Anaesthesia and Intensive Care Unit
BABE (Bioavailability & Bioequivalence)
Cardiology
Endocrinology
Gastroenterology
Haematology
Neurology
Obstetrics and Gynaecology
Oncology
Otorhinolaryngology, Head and Neck Surgery
Paediatrics (Hematology, Immunology,
Infectious Disease, Respiratory)
Phase 1 Clinical Trial Centre
Urology
Services
One-stop solution to manage your clinical research
Site Management
We provide site management services such as monitoring, regulatory submission by experienced clinical research specialist
CREC Submission
One-stop service on initial submission, amendments and renewals of clinical research ethics approval as well as SUSAR submissions
External Archival Service
Proper, secure, and traceable archival service for your trial documents
IMP Management
The Joint CUHK-NTEC Clinical Research Pharmacy (CRP) ensure safe and high-quality IMP management for non-phase 1 clinical trials
Early Phase Clinical Trial
Data generated from our China FDA accredited unit can be used worldwide, including China, US, Europe and Japan
Achievements
Over the years, we focus on providing outstanding services through unceasing effort
Harmonized SOP
We have harmonized and provided a reference set of Standard Operating Procedures (SOPs) applicable to all clinical departments for adoption and adaptation
CFDA Accreditation
Applicants of China FDA registration can entrust our 16 accredited Research Units with their trials
CRP Setup
The Clinical Research Pharmacy (CRP) has been established with the aims to provide central coordination and safe IMP management in compliance with GCP & regulatory requirements