Global Trials Hong Kong is a Hong Kong based clinical research consultancy. With extensive clinical trial proficiency in a wide variety of therapeutic areas, we provide clinical research services and GCP training to small or large biotech, medical device and pharmaceutical companies.
Global Trials HK can help you bring your products to market quickly and efficiently by providing clinical research support to your studies while helping you to navigate the local system. Global Trials HK maintains high quality standards and compliance with ICH GCP guidelines and applicable laws.
An ambitious self-starter with strong communication, problem solving, and decision-making skills, our Clinical Operations Director has over 14 years of experience in Clinical Research Project Management, Research and Development, medical devices, independent consulting, and early pharmaceutical studies.
Tiffany has managed all aspects of clinical research departments including strategizing at senior management level, developing departmental SOPs, recruiting/qualifying/training new investigators, IRB/Ethics submissions, writing protocols and consents for both human clinical and pre-clinical studies, Case Report Form design, monitoring, managing/directing/training CROs and in-house CRA efforts as well as representing clinical department for board of directors.
She has worked in USA-based companies ranging from small start-ups to large corporations within the medical device industry (in the U.S.) as well as with a university and a major pharmaceutical company (in Hong Kong). With a great deal of experience working on clinical trials in the USA, Canada, Europe, the UK, Mexico and Hong Kong regions, she is well versed in international clinical research and within a wide variety of therapeutic areas.
Our Medical Director brings medical and scientific expertise as well as clinical support / advice on medical issues for our projects in a number of therapeutic areas. With over 15 years of work experience in clinical practice, scientific and clinical research, she brings a wealth of in depth knowledge and experience to this role.
Educated in India and Hong Kong, the Medical Director of Clinical Trial Concepts is a physician-researcher with extensive medical knowledge, a strong academic and clinical research background, and broad post-specialization experience of clinical work, clinical research, teaching and medical writing involving various therapeutic areas in medicine.
She is an experienced medical writer and has developed high quality clinical study related documents, including protocols for phase I to Phase IV studies as well as protocols for investigational drugs and medical devices. Additionally, she has published numerous manuscripts in peer reviewed international medical journals.
Most recently, she helped establish and manage a research centre for clinical studies where she facilitated and supervised the conduct of clinical studies and provided first line emergency medical support. She was actively involved in clinical research education activities and provided strategic input in support of pre-study planning, preparation and subject recruitment activities for phase II and III studies.
• Site selection/Pre-study qualification – We help identity suitable investigators and prepare the site
• Protocol development – Review of protocols with pertinent input
• Case Report Form design – From protocol requirements to data input
• Informed Consent writing – In compliance with GCP and study protocol
• Report writing – Site initiation, interim monitoring, close out visits, IRB progress reports
• Project Management/Clinical Trial Management – Daily operations at the site can be overseen
• Monitoring – Site initiation, Interim, Close-out
• Training – GCP & Intro to Clinical Research for sites, investigators, IRB members, CRAs, industry
• IRB application/submission preparation – Assist in the process of IRB approvals
• Study recruitment – Help the site maximize study subject recruitment
Types of projects covered:
• From concept to commercialization – start-up to large company
• Clinical significance, epidemiology, retrospective
• Medical devices – e.g., orthopaedic, spine, cardiology, allergy/immunology
• Studies done in HK as gateway to China population
• Training sessions on GCP and general CRA concepts, including monitoring training.