All sponsors would like to start off their study as soon as possible and IRB approval is one of the determining factors. To ensure a smooth approval process, we offer Ethics Approval Tracking (EAT) service as an additional channel for sponsors who wish to keep themselves updated on the approval process.

Our professional team has extensive experience in conducting and planning clinical research including the development of clinical research protocols and consent forms, estimation of study budget and formulation of study plan. In addition to the traditional clinical trial designs, we can provide specialized consultation on multi-disciplinary and adaptive design study protocols.

The Phase 1 Clinical Trials Centre (P1CTC) is a purpose-built, 24-bed, NMPA accredited clinical research facility specifically designed to conduct first-in-man, early phase and clinical pharmacology trials. Our committed research teams, and dedicated facilities with access to ICU and PK/PD lab, enable us to conduct a wide range of early phase studies, such as first-in-human (FIH), BABE and pharmacokinetic trials.

We have over 20 years of experience in conducting early phase studies. Over 170 early phase studies have been completed in our hospital.

To fulfill each study’s manpower need, our well-trained study coordinators are fully equipped with skills and knowledge in planning and conducting clinical research. Flexible engagement plans are available to accommodate each investigator’s need.

Our experienced staff handle the application processes quickly and efficiently. Our services include:

• IRB approval application
• Regulatory submission

We provide a single point of contact for clinical trial related agreements vetting. We provide standard agreement/ amendment templates and work closely with the signing parties (Knowledge Transfer Office (KTO) of CUHK and the Legal Department of the hospital) to ensure that agreements are executed in the shortest period of time.

To ensure that a trial is performed in compliance with ICH-GCP and applicable regulatory requirements, we offer quality assurance service for sponsors who wish to have an independent assessment of all clinical trial associated activities. We can provide study specific QA plans to fulfill each sponsor’s requirements.

To ensure the quality of ongoing studies, we can provide on-site monitoring service throughout the studies. We will collaborate with sponsors and tailor made monitoring plans based on risk assessment.

Clinical Research Pharmacy (CRP) is a dedicated facility for central management of all study drugs. Access to CRP is strictly controlled and all transactions are documented according to SOPs.

CRP is equipped with the appropriate facility and equipment for coordinated IMP management in compliance with ICH-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

Investigational Medicinal Products (IMP) are strictly controlled items. Investigators should maintain records of IMP return to the sponsor or alternatively, the disposition of unused product(s).

Being licensed by the Hong Kong Environmental Protection Department (EPD), we can help study sites and sponsors to properly dispose of all expired, unused, or quarantined study drugs in full compliance with the local regulations. All study drugs using our Drug Disposal Service must be stored and managed by Clinical Research Pharmacy (CRP) throughout the study. The entire drug disposal process will be documented according to study requirements.

Research study documentation must be retained so that the data is accessible to monitors, auditors and inspectors after a trial has been completed. Appropriate arrangements for archiving research documentation should be in place prior to the study.

Our offsite archiving services is available for sponsors and investigators to meet their needs. Archived documents will be sent to selected document storage facilities. 24/7 online platform allows users to manage their archival activity anytime, anywhere.

Prospective budget can be estimated upon request during budget negotiation. We provide flexible terms of service and storage period (up to 25 years).

Our centre provides professional training based on international standards to address the needs of investigators, coordinators and other site personnel.

Over the past few years, we have delivered training to numerous study sites, research institutions and governmental organisations. Scope of training includes but not limited to:

• Clinical Trial Induction Program
• ICH-GCP
• Declaration of Helsinki
• Quality Assurance