CRMO offers one-stop service to sponsors who are intersted in conducting clinical trials in CUHK/PWH.
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.
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.
We organise and oversee the CTA vetting and negotiation. CTA can be executed after our review.
An indemnity agreement signed by the study sponsor is required for submitting to IRB for approval of application.
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/
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
Upon submission of CREC approval letter to DOH, a CTC can be obtained.
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
All clinical studies/research must apply for ‘Application for Conducting Clinical Trial/ Research Involving Patients in NTEC’ (Hospital Approval) before commencement.
CRMO provides study monitoring service. Sponsors can commission CRMO for site initiation, monitoring and study close out services.
Our clinical facility for early phase studies recruited over 2600 healthy volunteer over the past years from our database with around 10000 healthy volunteers.
