Centralised Contracting Office

Clinical trial start-up time is one of the key considerations when performing site selection for clinical trials. It includes time taken for clinical trial agreement negotiations, IRB approval, regulatory approval and site startup. The time taken for negotiating the clinical trial agreements can go up to six (6) months.

To address the slow contracting time due to legal issues, cost negotiations and response time, NCO has developed a master clinical trial agreement (MCTA) template for sponsored trials together with the Singapore Association for Pharmaceutical Industries (SAPI) and the three (3) public sector healthcare clusters (Singapore Health Services, National Health Group and National University Health System) to shorten contract review time. The terms and conditions in the MCTA template have been pre-negotiated between SAPI and the three (3) public sector healthcare clusters.

Who should be using the MCTA?

Sponsors interested in conducting clinical trials with public institutions across healthcare clusters will find the MCTA to be very useful as it contains pre-negotiated terms and conditions agreed by the healthcare clusters. The MCTA is also useful as a guide for biotechs and new start-ups.

How to use the MCTA?

Users can use the MCTA as is or can adopt the individual clauses into existing agreements. If users are using the MCTA as is, additional requirements to the study can be added to the SCHEDULE. Please write to ncb@scri.cris.sg to request a copy of the MCTA.


Harmonised Clinical Trial Budget Template for Fixed Cost Components

As part of SCRI’s ongoing efforts to strengthen Singapore’s clinical trials ecosystem and improve clinical trial start-up timelines, a harmonised clinical trial budget template for fixed cost components has been developed to support efficient budget preparations for Industry Sponsored Trial (IST) across Singapore’s public healthcare institutions (PHIs) with effect from 1 May 2026.

This initiative has engaged approximately 50 PHIs and industry partners across the ecosystem, with the shared goal of facilitating efficient and timely budget negotiations, and expediting clinical trial start-up processes in Singapore.

The harmonised template serves as a cost-neutral, overarching guideline that enhances clarity on charges for fixed cost components, thereby reducing the need for multiple rounds of clarification between sites and sponsors. It streamlines budget negotiations through the following key features
:

  • Standardised budget terminologies
  • Harmonised budget structure for fixed cost components
  • Improved clarity and transparency in site budgets

The template is applicable to all ISTs regardless of phase, nature or therapeutic areas. As the template only addresses fixed cost components, other charges (including pass-through costs and direct patient costs) will continue to be reflected in site-specific budgets.

Note: The inclusion of a line-item cost in the template does not imply mandatory charging. Only charges relevant to study-specific requirements and necessary for trial conduct will be reflected in site budgets.

For more information, please contact ncb@scri.cris.sg


Academic Research Organisation in Singapore

A business unit under the Consortium for Clinical Research and Innovation, Singapore (CRIS), Singapore Clinical Research Institution (SCRI) is a national academic research organisation, dedicated to enhancing standards of clinical research in Singapore by developing core capabilities, infrastructure and scientific leadership for clinical research.

Since its establishment in 1996, SCRI is committed to providing the necessary infrastructure to facilitate collaborative clinical research, ensuring that the research conducted was both cutting-edge and relevant to the needs of the community. Aligned with this commitment, SCRI has supported numerous multi-site, multi-national studies in Singapore and beyond.

SCRI’s team of clinical research and operation expertise comprises biostatistics, health economics outcome research, project management, data management, research monitoring and research monitoring.

To access or enquire for more information, kindly contact us.

 

Connect with Clinical Research Networks

Clinical Research Network (CRN) is a network of clinical investigators with research interests in the same disease areas. Opportunities are available for you to network with your professional counterparts, or to leverage our support for your own network of investigators. To learn more about SCRI’s CRN, please click here or contact us.

 

Clinical Research Service Providers in Singapore

In Singapore, a hub for biomedical sciences and clinical research, Contract Research Organisations (CROs) and other clinical research service providers play an indispensable role. These companies bring specialised expertise, ensuring that clinical trials adhere to both local and international guidelines. CROs, especially, with their global reach and deep understanding of Singapore’s regulatory landscape, allow for efficient multi-centre trials. These clinical research service providers give sponsors the flexibility to navigate the complexities of clinical research, while ensuring timely completion and adherence to the highest standards.


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*Data accurate as of Oct 2024


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