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Clinical Trials (For Industry)

Industry partners are requested to refer to the following integral administrative requirements prior to conducting a research study in SERI.

Research Clinic

SERI houses a dedicated research clinic facility that includes several consultation rooms with specialised state-of-the-art equipment and cutting-edge tools to conduct comprehensive clinical trials and research studies. Click here for more information.

Clinician Contacts

Ethics and Regulations

Ethics approval must be obtained before a study commences at SERI. Please visit the Centralised Institutional Review Board (CIRB) website for more information. Regulatory approvals must be obtained before a study commences at SERI. The sponsor or their duly-appointed Chief Research Officer (CRO) is responsible for the administration of all regulatory processes required prior to the conduct of a clinical study.

For the import of all classes of unregistered medical devices (Class A, B, C and D) for use in clinical trials (both investigational and non-investigational purposes), you would need to apply for their use via the CTM (Medical Devices) application form. One CTM form is to be submitted for each clinical trial. It is the responsibility of the Sponsor to obtain HSA approval and forward the approved CTM (Medical Device) form to the importer. A sponsor can designate this responsibility to a duly-appointed CRO. Please visit the Health Sciences Authority of Singapore (HSA) website for more information.

Legal and Finance

The Clinical Trial Agreement (CTA) and the study budget have to be discussed and finalised prior to study commencement. However, this can be done concurrently with the ethics and regulatory approval process.

The Clinical Trial Agreement (CTA) between SERI and the industry partner, which incorporates the approved budget, must be executed. Typically, the standard practice at SERI is to commence with the budget negotiation, and proceed thereafter with the CTA review, as the budget has to be incorporated within the executed CTA.