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Site Management Services
Study site budget management is not only a financial matter but more importantly is linked to the proper, ethical and efficient conduct of clinical studies. Likewise, signing of a clinical trial agreement (CTA) is an essential step before initiation of any sponsored clinical study or collaborative investigator-initiated clinical study. Efficient CTA discussion and execution is commonly deemed a rate-determining step for study startup.
GHK collaborates with HKU-CTC to prepare budget and industry-sponsored CTA. Site budget management is integrated with site operations to ensure all study requirements are well-considered, and resources and equipment are available for proper completion of each clinical study. For sponsor-initiated study, CTAs are centrally managed by HKU-CTC. CTAs will be updated from time to time in accordance with the latest international and local clinical study requirements. Sponsors and collaborators are welcome to develop organization-specific CTA templates.
The Clinical Research Pharmacy Team manages all investigational products (IP) which are critical to study data quality and protection of study participants. The Team is responsible for:
- safeguarding subjects by ensuring that IP are appropriate for use, and handled and stored safely and correctly
- conducting IP receipt, dispensing, re-labelling, storage, transfer, disposal in accordance with the protocol
- inventory control
- ensuring all pharmacy clinical trials procedures comply with relevant guidelines and regulations
The HOKLAS accredited laboratory in GHK is experienced in working under stringent and comprehensive GHK SOPs to support specimen collection and evaluation, and ensure good data quality. Packaging of specimens for local and overseas transportation will be performed by IATA-trained personnel.
Clinical studies are multidisciplinary activities which require close collaboration of multiple parties. The Clinical Research Pharmacy Team shall coordinate with relevant parties to arrange a site initiation visit (SIV), and ensure the necessary access rights are granted to the responsible staff members before study commencement.