About Us
Our Services
Bridging the gap between sponsors and investigators.
Regulatory Consulting
We know the country, we know the regulations and we know the requirements. Do we need to say more?
Biostatistics
Some of our capabilities include data analysis, randomization, modelling and calculating sample size.
Training
Our training curriculum is up to date and practical. We are training employees to think critically.
Site Management Organisation
We believe quality sites are shaped by high quality research teams. We are able to deploy good CRCs to support studies.
Project Management
Our experienced Project Managers understand Asia Pacific's research landscape.
Clinical Operations
Our CRAs, Regulatory Start-Up Specialists and Clinical Operations Managers will work closely with sites to complete enrolment in a timely manner and at the same time focus on achieving good quality data.
Medical Monitoring
We have over 17 years experience conducting clinical research. Our medics are able to provide sound medical oversight of your studies.
Pharmacovigilance
Our safety team will ensure your safety information are reported in a timely manner as per the local regulatory requirements.
Case Studies
SCALING NEW HEIGHTS!
The FDA requested that a customer provide data to demonstrate if their algorithm coupled with the monitoring device will work in a different physiological environment. CSI helped to connect the customer with Singapore's medical center with a working hyperbaric chamber. Trial successfully completed within the scheduled timeline.
YOUR LOCAL CRO
CSI leveraged on the knowledge of key stakeholders and regulators to assist our China-based customer to navigate the regulatory requirements and to help align expectations. The customer was able to consult regulators openly and obtain pivotal information to initiate their first-in-human study in Singapore.
SPEEDY HIGH QUALITY EXECUTION
With no IB, only a draft Protocol, incomplete safety data and lacking IP stability data, CSI was able to mitigate the gaps and work with customer on closing them. The protocol was finalized on 14 Oct and IRB submission completed on 19 Oct.
REGIONAL PRESENCE
CSI has a good partnership with other established local CROs in the region. CSI has helped customers to provide governance and oversight of our partners to ensure good quality delivery.
YOUR LOCAL CRO
CSI leveraged on the knowledge of key stakeholders and regulators to assist our China-based customer to navigate the regulatory requirements and to help align expectations. The customer was able to consult regulators openly and obtain pivotal information to initiate their first-in-human study in Singapore.
SPEEDY HIGH QUALITY EXECUTION
With no IB, only a draft Protocol, incomplete safety data and lacking IP stability data, CSI was able to mitigate the gaps and work with customer on closing them. The protocol was finalized on 14 Oct and IRB submission completed on 19 Oct.
MEDICAL COVERAGE
Our medic has been able to provide sound medical oversight on our studies. This includes holding safety review meetings to present the safety data to committee members before dose escalation.
QUALITY RISK TRIGGERS
CSI provides a checklist that helps in determining what type of visits would be required for your study.