Site Management

Efficient site management is the key to a successful clinical trials. Our qualified and experience site management team provides comprehensive services to safeguard the compliance and provide timely support throughout your trial.

Our services include but not limited to

  • Site Monitoring
  • Regulatory submission

CREC Submission

To apply clinical research ethics approval, we provide a one stop application service for those who are interested

  • Providing administrative support for initial submission, amendments, and annual progress reports at a minimal cost
  • Providing biweekly submission services for SUSAR
  • Reducing administrative workload and hassle from research teams
  • One stop solution for ethics approval, indemnity agreement, clinical trial insurance (for Investigator-Sponsored Trial only) and hospital approval

External Archive Service

Proper, secure, and traceable archiving are essential requirements to retain clinical trial documents. Offsite document storage service provided by an international archival service is now available at CRMO at a reasonable price. Prospective budget can be estimated upon request. Please contact CRMO for more information.

IMP Management

The Clinical Research Pharmacy (CRP) is equipped with appropriate facility and security to offer coordinated IMP management in compliance with GCP and other regulatory authorities

Scope of service includes

  • Professional advice on regulatory and contractual requirements on IMP management
  • Coordination of study monitoring visits/ audits or inspections by accreditation or regulatory authorities
  • Effective IMP inventory management and dispensing with accurate and confidential storage of all documents and records

A standardized charging model is applied for the IMP management to maintain the efficient operation of the pharmacy

Early Phase Clinical Trial

World-class Clinical Trial Centre provides the top services

  • China FDA accredited Phase 1 unit
  • Dedicated research facility for early phase studies
  • Locates in an acute general hospital with Intensive Care Unit
  • Over 15 years of experience in early phase clinical research
  • Over 140 Phase 1 and BABE studies completed
  • Fully functional PK/PD laboratory
  • Customized early phase clinical research services

You may click here to learn more about Phase 1 Clinical Trial Centre.

CUHK- Clinical Trial Related Agreement

In order to further enhance the clinical trial related agreements review process, with effective on 1 Aug 2018, all clinical trial related agreements (initial and amendment) will be reviewed and vetted by CRMO.

All CUHK clinical trial related agreement (initial and amendment) should be routed to CRMO at crmo.cta@cuhk.edu.hk. The email subject must contain all three information including Protocol no./PI name/ Sponsor. CRMO will handle and review the agreement.

For any queries, please contact CRMO at 3505 1032.

Consultation

Our consulting team provides professional advices for your needs

  • Protocol and Consent form design
  • Study start up
  • In-house training
  • Budgeting
  • Study coordination
  • Quality assurance services