Since 2016, seleon has been conducting a clinical trial with a medical device in several research centers as the contracted CRO. Two centers are located in Singapore. The study deals with a therapy device for the treatment of benign prostate hyperplasia (BPH). With the following article, we would like to outline our impressions of the study process in Singapore.
Singapore focuses on research in medicine
Singapore, as a highly modern and economically very strong financial and trading state, is an important trading center in Asia. The city-state has become one of the most important locations for biomedical and pharmaceutical research in Asia thanks to its targeted policies and virtually non-existent corruption.
Emphasis in biotechnology has been placed on bioengineering, medical technology and pharmaceutical research and focused, for example, in the Biopolis research and development center. The broad research landscape attracts many internationally renowned researchers and scientists as well as important international companies.
Advantage multiculturalism
The population structure, with its ethnic breadth, is ideally suited for studies that require a multicultural focus. The population of 5.6 million people (2016, source Wikipedia) is composed of 76.6% Chinese, 13.8% Malays, 7.9% Indians and 1.4% of other ethnicities.
Of course, as before any study, it is important to carefully plan the duration of the recruitment phase based on the population structure and the study objective. Attention should be paid to parallel studies with a similar focus, which is not uncommon in this scientifically oriented country and may well have an impact on one’s recruitment phase.
Advantage English language
The official language English facilitates communication with the authorities and all parties involved in the study. Study documents are submitted in electronic form in English. International legalization is not required.
Depending on the patient target group, it may be necessary to have patient-relevant documents such as consent and questionnaires translated into Chinese and possibly Malay by a certified translation agency.
Standardized regulatory processes
Singaporeans are used to working efficiently. Official communications and formalities are usually handled electronically via the Internet. Study applications are no exception.
Medical devices and clinical trials are regulated by the Health Sciences Authority (HSA). The processes and extensive guidance (structured by GN numbers) are very much based on the harmonization framework of ASEAN (Association of Southeast Asian Nations) and the International Medical Device Regulators Forum (IMDRF) and have a lot in common with European guidelines.
Procedures for submission, implementation and reporting can be found on the well-structured HSA website. The Guidances facilitate the work.
Since 2018, electronic communication with the HSA as a government authority and the use of the e-service require companies to obtain a so-called CorpPass, which must be applied for electronically.
Ethics committee approval was obtained from SingHealth as one of four ethics committees for the study, which is accompanied by seleon. SingHealth uses the iSHaRe platform. This website enables the management and monitoring of the study portfolios by both the ethics committee and the study team.
Monthly submission deadlines, processing periods, and IRB costs are updated regularly on the web.
A clinical trial in Singapore should be registered through the HSA Clinical Trials central registry and the study portfolio updated by the sponsor every six months.
Highly trained physicians and clinical staff
The multi-center study currently organized by seleon as CRO is being conducted in Singapore at the two largest hospitals, National University Hospital and Singapore General Hospital. Both institutions are known for their renowned research activities and have clinical research centers with appropriately trained staff.
The work with both centers is very communicative and constructive
Read also part 1!
Please note that all data and listings do not claim to be complete, are without guarantee and serve purely as information.
