Case Study | Csi Medical Research

Case Study.

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 customers were able to consult regulators openly and obtain pivotal information to initiate their first-in-human study in Singapore.

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 October and IRB submission completed on 19 October.

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.