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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 MR helped to connect the customer with a medical centre in Singapore that has a working hyperbaric chamber. The trial was successfully completed within the scheduled timeline.
Your Local CRO
CSI MR 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.
With no IB, only a draft protocol, incomplete safety data, and lacking IP stability data, CSI MR was able to mitigate the gaps and work with the customer on closing them. The protocol was finalised on 14 October, and IRB submission was completed on 19 October.
CSI MR has a good partnership with other established local CROs in the region. CSI MR has helped customers to provide governance and oversight of our partners to ensure good quality delivery.
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