CSI Medical Research: CRO for Clinical Trials in Singapore

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

20 February, 2021

Nelson Wong is the Founder and Managing Director of CSI Medical Research, a Singapore-based clinical research organization (CRO) dedicated to providing clinical trial management services for biotech and pharma companies.

Our dialogue with Nelson will give an overview on conducting clinical trials in Singapore, remarking the advantages of doing clinical research in this country. We will also facilitate strategic advice for biotech and pharma sponsors planning to execute clinical trials in this part of the world.  

Patricio Ledesma (PL): Nelson, it is great to speak with you. Thank you very much for joining us in this interview.

Nelson Wong (NW): Thank you Patricio for giving me an opportunity to speak to you. 

PL: How did you start working on clinical trials? Could you tell us about your academic background and expertise in the clinical research space?

NW: I am always passionate about improving science for the betterment of mankind. Graduated with a degree in biotechnology with the University of Singapore, I started working as a research scientist in development test kits for diseases. After a few years of bench work, I came across an acquaintance whose work in clinical trials inspire me that I can be close to patients to make a difference. So, I decided to cross over to clinical research in 2003 and I never looked back. Worked through the ranks of clinical research coordinator, clinical research associate, clinical lead, project manager, line manager, operations head, country lead, country general manager, South East Asia Operations head and now founded my own company to provide clinical development services. 

PL: Does Singapore have a long tradition in the field of clinical trials? Could you describe the general clinical research scenario in Singapore right now?

NW: Singapore has been prominent in conducting clinical research. Quintiles (now IQVIA) setup their first Asia headquarters in Singapore in 1995. Singapore government has prioritized clinical development and pharmaceuticals related jobs back in early 2000s.  

PL: Are there many U.S. and European sponsors conducting trials in Singapore? 

NW: Yes, there are. Singapore has a lot of advantages when it comes to clinical trials. Some examples are: supportive government, good clinical trials infrastructure, established clinical trials regulatory systems and processes, key opinion leaders and an English-speaking workforce. Singapore has a lot of targeted therapeutic societies where investigators here in Singapore have important positions. They can leverage their influence within these societies to help with patient referral and recruitment. A lot of US and European sponsors find Singapore an easy place to run clinical trials due to all of the above. 

PL: Why would you recommend Singapore as a destination to execute clinical trials? What are the advantages of Singapore for clinical research?

NW: Singapore has one of the most streamlined regulatory and IRB review processes. Singapore regulatory, Health Sciences authority, has a target review and approval timeline of 30 working days. Singapore’s IRB approval in general we will take about 45 to 60 working days. No translation of protocol and most study documents are required. Singapore also has good clinical trial sites that are familiar with conducting trials in most therapeutic areas.

The vibrant clinical trial environment, the maturity of the clinical trial related infrastructures, the key opinion leaders, etc. On top of that, Singapore offers a well-trained clinical trials workforce, established site processes, hospitals emphasis on clinician scientists that enable physicians to dedicate their time into research, and assured quality in the trials. 

Singapore IRB, regulatory and research offices carry out periodic reviews, audits and inspections of the studies here to ensure the patient’s rights and well-being, as well as their safety, are not compromised. In addition, Good Clinical Practice is legislated here in Singapore and everybody takes clinical research seriously. 

PL: According to your experience, in general, what are some key aspects to ensure a high quality and successful clinical trial? 

NW: The key to ensure high quality and successful clinical trials includes the following: 

  • Well trained site personnel
  • Well thought out risk mitigation plan
  • Periodic review of quality observations and trends
  • Timely mitigation of any quality concerns 
  • Effective communication between sites and sponsor
  • Accountability of various stakeholders

PL: What is CSI Medical Research core capabilities? How do you help sponsors manage clinical studies?

NW: CSI medical research is a boutique CRO that provides industry quality services to emerging biotech and pharma companies. We leverage on the experience we have gained over the years and invest on automation that can complement the type of work that is typically reliant on experienced manpower. This will improve efficiency and remove unnecessary processes that can impact the overall quality of the studies. CSI wants to be the preferred partner of companies wanting to place studies in Southeast Asia but have limited or no experience in this region. We hope to be the guiding Shepherd that the customer can trust.

PL: Do you have contacts with key opinion leaders and high volume recruiting sites in Singapore? I think this is a great added value to offer to foreign sponsors. 

NW: We have been working in this region and particularly in Singapore for over 18 years. We have established a good network of investigators and key opinion leaders to help us in placing studies in Singapore as well as in the region. Many of the key opinion leaders worked as consultant or registrar when they started out their career. We are proud to say that we have been able to establish good working relationships with all these important stakeholders.

PL: Let’s consider an international, large phase 3 clinical trial. Would you recommend using a global CRO like IQVIA or rather having medium to small size CROs working as a network? What are your thoughts on this?

NW: Global CROs can provide full-service scope but customers sometimes find it difficult to navigate within the complex hierarchy to get information. Medium to small size CROs usually have flatter reporting structure and the customer experience would be more personalized. To give you an example, a customer wants a study to have a first patient in within 4 months of protocol finalization. Smaller CROs can be very flexible in how they strategize in achieving important study milestones. This is done through understanding the processes, pre-empt the sponsor to prioritize certain key rate limiting processes, mitigating risks of potential delays, etc. For CSI, we have been able to demonstrate time and again on how local knowledge and risk planning has been successful in helping our customers reach many firsts!

PL: U.S. and European sponsors may wonder about the quality of clinical trials conducted in less known Asian countries. How is clinical data quality ensured in Singapore? 

NW: Singapore has developed into a recognized medical hub with good health infrastructures that support the population health care needs. The clinical trials segment has also been growing strongly aided by this robust development. In addition, Singapore government realizes the potential and importance of clinical development that can boost its scientific standings and the economic benefits in the long run. As such, a huge injection of funds was made available to train up clinical research coordinators as well as investigators. Singapore government heed advice from the industry that the need of strong site support would bring many advantages in attracting studies into Singapore. This and the long standing history of clinical development have put us in the forefront in terms of the quality of the studies conducted here. 

PL: Thanks a lot for this nice talk Nelson. Your thoughts were very useful and I think our readers will benefit from them.

NW: Thank you Patricio for giving me this opportunity to share with you about our lovely Singapore. 

About CSI Medical Research

CSI Medical Research is a Singapore headquartered CRO that focuses on bringing studies to South East Asia. Looking to partner emerging Biotech and pharmaceutical companies, CSI is always looking for innovative and effective solutions for our customers to achieve their desired goals. CSI Medical Research is founded in 2017 and is now an emerging local brand in the clinical research industry as its founder have been able to leverage the wide network, relationship and knowledge to assist their customers. The continued support from returning customers speaks volume of the service standards that have been well received and appreciated by our customers. CSI Medical Research plans to be the preferred local CRO for South East Asia. 

For further information about conducting clinical trials in Singapore, please contact us at: info@sofpromed.com 

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com