Case Study

Next-generation Class III research system

Our client’s existing system for patient monitoring during Phase III clinical trials was nearing the end of its life. The system was no longer manufactured, and there were no suitable replacement systems available on the market. The client approached Team to design the next-generation system which is equivalent, maintains the core functionality and usability, and to look at additional functionality and enhancements in efficiency.

The system is required to continually monitor the subject’s physiological parameters and reaction to the drug intervention during clinical trials, and to administer a counter-acting infusion where the infusion rate is determined using an advanced algorithm. This Class III embedded safety-critical control system automates this process seamlessly, and provides the clinical investigation team with real-time information through a simple-to-use graphical user interface (GUI), and all data is stored on a 21 CFR part 11 compliant database.

The system is in development ahead of clinical trials.

“The new system will deliver a range of benefits to us, such as being less clinician-dependant and more efficient. Team have done a great job on ensuring the new system is equivalent to the current one, whilst delivering a number of enhancements that will make the whole system far easier to use.”