Case Studies

Scaling New Heights

The Food and Drug Administration (US 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 Medical Research helped to connect the customer with a medical center in Singapore that has a working hyperbaric chamber. The trial was successfully completed within the scheduled timeline.

Your Local CRO

CSI Medical Research 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

Despite initially lacking an Investigator’s Brochure (IB), complete safety data, and stability data for the Investigational Product (IP), CSI Medical Research successfully addressed these gaps and collaborated with the customer to resolve them. The protocol was finalized on 14 October, and the Institutional Review Board (IRB) submission was completed on 19 October.

Regional Presence

CSI Medical Research has a good partnership with other established local CROs in the region. CSI Medical Research has helped customers to provide governance and oversight of our partners to ensure good quality delivery.