YOUR SELEON SPECIALIST

Alexander Onghay
Senior Consultant Clinical Affairs

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

 

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28.10.2018

Testimonial: Clinical studies in Singapore. Part 2

The author tells about the experiences gained during a clinical study of a therapeutic device for the prostate in Singapore. The city state has evolved into one of the most important places for biomedical and pharmaceutical research in Asia.

In 2016 seleon was assigned as CRO and has since been conducting a clinical investigation with a medical device in multiple research centres. Two of the centres are located in Singapore. The clinical investigation involves a therapeutic device for treating benign prostatic hyperplasia (BPH). This article outlines our impressions of the investigation’s course in Singapore.

 

Singapore focuses on medical research

As a highly contemporary and economically powerful fiscal and trading state Singapore occupies an important place for trade in Asia. Owing to its directed politics and the virtually absent corruption the city state has evolved into one of the most important locations for biomedical and pharmaceutical research in Asia.

Biotechnological key subjects are bioengineering, medical engineering and pharmaceutical research. The research and development centre Biopolis for example focusses on these key subjects. The broad research landscape attracts numerous international renowned researchers and scientists as well as important international companies.

 

Advantage Multiculturalism

Based on its ethnic diversity the demographic structure is perfectly suited for studies that require a multicultural orientation. The population of 5.6m (2016, source: Wikipedia) consists of 76.7% Chinese, 13.8% Malayan, 7.9% Indian and 1.4% other ethnicities.

As before any study it is of course important here as well to plan the duration of the recruiting phase based on the demographic structure and the endpoint thoroughly. In addition attention should be paid to parallel running studies with a similar focus, which is not uncommon in the science-oriented country and may well have an impact on one’s recruiting phase.

 

Advantage English Language

As English is the administrative language, communication with authorities and all parties involved in the study is facilitated. Study documents are submitted electronically and in English. An international legalisation is not required.

Depending on the target patient group it may be required to have patient-related documents such as consent form and questionnaire translated into Chinese and maybe also Malayan by a certified translation agency.

 

Standardised administrative procedures

The Singaporeans are used to work efficient. Administrative communication and formalities are usually handled electronically via the internet. The clinical investigation application is no exception from this.

Medical devices and clinical investigations are regulated by the competent authority Health Sciences Authority (HSA). The processes and substantial Guidances (structured using GN Numbers) are strongly oriented towards the harmonisation framework of ASEAN (Association of Southeast Asian Nations) and the IMDRF (International Medical Device Regulators Forum), in addition they have many things in common with the European Guidelines.

Proceduress on submitting, conducting and reporting can be derived from the well-structured Website der HSA entnommen werden. The Guidances make the work much easier.

Since 2018 companies need a CorpPass for electronically communicating with the HSA as regulating authority and for using the E-Services which can be applied for electronically.

The consent from the ethics commission for the study accompanied by seleon was granted SingHealth, one of the four ethics commissions. SingHealth uses the iSHaRe platform. this website allows for administration and monitoring of the study portfolio by the ethics commission as well as the study team.

Monthly submission deadlines, processing periods and costs of the IRB are updated in the internet on a regular basis.

A clinical investigation in Singapore should be registered using the central HSA Clinical Trials Register and the study portfolio must be updated by the sponsor at least every 6 months.

 

Highly educated physicians and clinic staff

The multicentre study currently organised by seleon as CRO is conducted in Singapore’s two largest hospitals National University Hospital and Singapore General Hospital. Both institutes are renowned for their prestigious research activities and feature clinical research centres with appropriately trained personnel.

Working with both centres is very communicative as well as constructive.

 

Read also Part 1!

 

Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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