Sponsors and PIs as its first priority
The center gives priority to the safety of the subjects and does not require the sharing of intellectual property or product profits in order to provide international professional clinical trial services for PIs and manufacturers and to assist domestic and foreign firms to develop new drugs or new medical materials.
Efficient execution of cases
Saving money and time costs for sponsors is the principle of the center implementing various services. The contract review accepts the version provided by the firms without Chinese language translation to save the waiting time for translation. Meanwhile, contracts and trials are allowed to be submitted for approval at the same time, so as to save the review time, while manufacturers or the CRO company are encouraged to agree on the contract template with the hospital in advance, in an effort to impel the future application of cases. Currently, the response time for new cases submitted averages three days.
The center, by imitating Harvard University, created the first academic research organization (ARO) in Taiwan, in which the Clinical Trial Center provides the mechanism of the various services required for the in-house CRO and offers sponsors or PIs services ranging from consultation, writing proposals, producing investigator brochures, drawing up informed consent forms, submitting protocols for review, data analysis, and safety monitoring. The center's ARO has been approved by the US National Institutes of Health and the Australian government, and was commissioned by them to coordinate the multi-center clinical trials performed in Taiwan. It not only saves costs, but also accords with the quality and efficiency required by international multi-center trials. Recently, it was also entrusted by domestic companies with assisting in the implementation of the clinical trials of medical materials.
The center also plays the role of the site management organization (SMO), helping full-time research nurses conclude the case and managing the services required for the test organizations. All services provided by the center are available whether through the center chief, ARO OR SMO commissioning the center to carry out relevant business.
Provide perfect clinical trial facilities
The hospital is well-equipped with clinical trial facilities, including the clinical trial ward, outpatient and diagnostic area, clinical trial pharmacy awarded with the Symbol of National Quality (SNQ), and medical laboratory presented with accreditation from the US College of American Pathologists (CAP) and ISO 15189. The center also provides − 20°C, − 80°C and 4°C refrigerators for storage of specimens, and the equipment is regularly rectified to ensure its efficiency. Moreover, the center offers original document retention services after the experiment. All the facilities were set up in accordance with the good clinical trial and drug clinical trial specifications.
Offer professional education training at international level
The center has brought in University of Hong Kong Clinical Trials Centre director and deputy director for two consecutive years to give accreditation courses recognized by international pharmaceutical firms. Further, it occasionally invites senior managers from international pharmaceutical companies and experts with practical experience in different departments to share their experience in implementing clinical studies. In addition, the center often runs clinical trial credit courses and launches an online learning platform, so that clinical trial practitioners free from time and place constraints can take the opportunity for advanced studies and earning professional credits.
Host an international clinical trial practices forum
In 2017, the center chief in his capacity as Taiwanese ambassador for the SCRS invited the SCRS representative to the forum. In addition to explaining the composition and operation of the SCRS, it arranged for international pharmaceutical companies and international CRO representatives to have a discussion with 21 Taiwanese clinical trial institutions present, exchanging their views so as to facilitate mutual understanding and cooperation.