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Study Protocol Development

Each clinical study aims at answering one or more research questions. Success in achieving study objectives relies on an appropriate study design and a well-written study protocol.

HKU-CTC has a protocol development team comprising professionals in clinical and medical sciences, project management, ethics and regulatory affairs, study operations, data management, medical statistics, finance and quality assurance, which guarantees full coverage of all required perspectives. It has experience in developing protocols for various types of clinical studies – such as drug trials, device trials, Chinese medicine trials, alternative therapies and observational studies – whether industry-sponsored or investigator-initiated. Its good collaborative relationship with investigators and deep understanding of the local clinical research environment facilitate it in developing protocols that are both scientifically sound and practically feasible.

Highlights
Protocol development team comprising professionals in clinical and medical sciences, project management, ethics and regulatory affairs, study operations, data management, medical statistics, finance and quality assurance
Direct communication with local investigators and full understanding of local clinical research environment
Experience in developing protocol for industry-sponsored and investigator-initiated clinical studies