Trials Registration / Startup
CRMO offers one-stop service to sponsors who are intersted in conducting clinical trials in CUHK/PWH.
NDA/ Feasibility NDA/ Feasibility
We facilitate the signing of NDA beween Investigators and Sponsors.
We also explore the feasibility of specific studies in our institution, such as availability of investigators, manpower and study subjects, etc.
Mutual Agreement between PI and Sponsor
Once mutual agreement between PI and Sponsor is made, our team will start preparing for the trial start-up process.
Our team has extensive experience in compiling Clinical Study Protocols according to ICH guidelines. Each protocol is developed in collaboration with the Sponsor in order to fulfil the trial requirements and objectives.
Clinical Trial Agreement (CTA) Negotiation & Vetting
We organise and oversee the CTA vetting and negotiation. CTA can be executed after our review.
Indemnity signed by Sponsor
An indemnity agreement signed by the study sponsor is required for submitting to IRB for approval of application.
IRB/ Clinical Research Ethics Committee (CREC) Submission
Undertaking IRB submissions on behalf of our clients
Our experienced team can prepare the full dossier for IRB submissions. We work closely with our local IRB, the Joint CUHK-NTEC Clinical Research Ethics Committee to ensure approvals can be obtained in a timely manner.
Website: https://www.crec.cuhk.edu.hk/
Department of Health (DOH)
A Certificate for Clinical Trial (CTC) is required for the purpose of conducting a clinical trial on human beings or a medicinal test on animals.
Undertaking regulatory submissions on behalf of our clients
Our experienced team can prepare the full dossier for regulatory submissions.
Guidelines: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidance_Notes_en_Version.pdf?v=nhnc2c
IRB/ CREC Approval
Indemnity signed by CUHK
Clinical Trial Certificate (CTC)
Upon submission of CREC approval letter to DOH, a CTC can be obtained.
IMP Management undertake by CRP/
Phase 1 Clinical Trial Centre (P1CTC)
IMP storage are well-equipped with appropriate facilities to accommodate with IMP management in compliance with GCP and other regulations
Scope of service includes:
►Professional advice on regulatory and contractual requirements on IMP management
►Coordination of study monitoring visits/ audits or inspections by study sponsor or regulatory authorities
►Effective IMP inventory management and dispensing
►A standardized charging model
Indemnity Signed by Hospital Chief Executive (HCE)
Hospital ApprovalAll clinical studies/research must apply for ‘Application for Conducting Clinical Trial/ Research Involving Patients in NTEC’ (Hospital Approval) before commencement.
CTA signed
Site Initiation Visit (SIV)
CRMO provides study monitoring service. Sponsors can commission CRMO for site initiation, monitoring and study close out services.
Subject Recruitment
Our hospitals serve 1.3 million residents in Hong Kong with over 8000 attendances per day. Well-established transport network also minimizes travel for patients. Using our efficient recruitment techniques, adaptive study designs and integrated protocols, we can further reduce our sponsors’ drug development time.
Our clinical facility for early phase studies recruited over 2500 healthy volunteer over the past years from our database with over 9000 healthy volunteers.