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Clinical Research

At TCELS we are constantly striving for innovation and excellence. One of our objectives is to facilitate and advance high-quality clinical research. We provide the necessary links between Contract Research Organizations (CRO) within and outside Thailand. We also network investigators and researchers.

TCELS has initiated Multi Center Institutional Review Boards (IRBs) in most medical schools and research centers and has upgraded the Clinical Research Site to standardize and streamline all clinical research and trials. TCELS also supports the Medical Research Network (MedResNet) to manage the Thai Clinical Trial Registry (TCTR) system.

Companies who wish to register clinical trials in TCTR system are obliged to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (WHO-ICTRP) dataset. TCTR also aims to be a research database for clinical researches in Thailand. We welcome the registration of all kinds of clinical researches including clinical trials and observational studies. According to Clinical Trial Magnifier, April 2011, Thailand ranked seventh in Asia in terms of the number of trials conducted.

To promote clinical research, TCELS has also set up International Clinical Research Collaboration Centre (ICRCC) in association with the World Health Organization’s special programme for research and training in tropical research, the Pharmaceutical Research and Manufacturers Association (PReMA) and the Clinical Research Collaboration Network under the Consortium of Thai Medication Schools. ICRCC’s objectives are to develop infrastructure and upgrade the standard of clinical research by serving as a center for clinical testing of new products. It is housed at TCELS and coordinates the testing of products from different agencies.

Thailand offers unique opportunity for researchers focusing on tropical diseases such as dengue, malaria, SARS, diarrhea, avian flu and Japanese encephalitis. Research opportunities in Thailand also include therapeutic areas such as respiratory, cardiovascular, endocrinology, dermatology, oncology and infectious diseases such as HIV and hepatitis virus infection. A growing clinical development sector is providing many opportunities to participate in clinical trials. Thailand has a large subject population and a pool of experienced investigators.

Data Management Centers in Thailand follow 21 CFR Part 11, which declares that the computer systems used in a regulated data management environment must be validated depending upon user’s requirements in specific working environment. The aim of the validation is to maintain accuracy, reliability, availability and authenticity of the required records and signatures. A number of sites have also implemented electronic Case Report Forms (CRFs).

In the emerging biopharmaceutical industry of Thailand, high priority will be given to research and development and clinical trials. TCELS will play a significant role of coordinating and networking these efforts. www.clinicaltrials.in.th

23-August-2017