Health is an essential part of life. Therefore, it comes as no surprise that there is a continuous race to produce good new drugs and vaccines, even to better the products already in the market.
New drugs will have to be trialed for efficacy and safety before they can be marketed. The Clinical Research Unit (CRU) intends to provide researchers, sponsors, and other drug producers, the scientific tools and facilities to carry out studies in compliance with GCP standards.
The CRU is a unit of the Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, a spin-off from the Vaccine Trial Centre for conducting and facilitating clinical trials on behalf of sponsors, researchers and other commercial entities, providing trained personnel and managing the studies to comply with GCP standards. The CRU will be clinical site managers, performing such tasks as:
Teaching and training site staff to perform clinical trials to GCP standards, including training courses, workshops and seminars.
As site managers, The CRU monitors the clinical process, to ensure that all ethical and regulatory issues are met.
The CRU monitors the status of each trial for volunteer recruitment, trial progress, and the collection of quality data on a timely basis.
The CRU provides data management and statistical analysis (by outsourcing to Data management unit
)
The CRU is the link between the study sponsor and the investigators and site personnel.
The CRU provides clinical research staff with experience in clinical trials. They are trained in research methodology, working under ICH GCP guidelines and FDA requirements.
In support of the clinical research process, CRU provides regular courses in Good Clinical Practice as training is a primary requirement for participation in all clinical trials. CRU’s vision is that Mahidol University will eventually be able to offer Master’s degree programs in clinical research for doctors, nurses or other science personnel, to promote and encourage interest in this field.
To summarize, The CRU’s Mission is to manage and provide sponsors and researchers the scientific tools and facilities to conduct clinical trials, in GCP compliance with the standard.
The CRU has the operational infrastructure for the full spectrum of services required for conducting clinical trials in Thailand, as follows:
Protocol development, study design and methodological advice
Protocol and consent form (in both English and Thai languages) preparation.
Translation
GCP and other site training
Case Record Form (CRF) design and development
Monitoring study progress to GCP standards
Application for new drug registrations in Thailand
Application for lab kit/Medical device/study drug import permit license
Preparing clinical trial application documents for submission to the relevant authorities
Facilitating Institutional
Review Board (IRB) and Ethical Committee (EC) approval for all studies.
Statistical analysis
Data management and laboratory services (outsourcing).
Administration:
Chief of CRU – Prof.Dr.Punnee Pitisuttithum
Head, Department of Clinical Tropical Medicine - Prof.Punnee
Pitisuttithum
CRU under Faculty of Tropical Medicine – Assoc.Prof.Dr.Pratap Singhasivanon, Dean
