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Berlin – London: Remote neurophysiological monitoring during a phase-I drug trial

Pharmaimage (Berlin, Germany) and the Clinical Research Organization (CRO) Hammersmith Medicines Research (HMR) in London (UK) have established a real-time neurophysiological/video monitoring system as part of a new phase-I drug trial.

 

Using a secure web-based remote monitoring system for electroencephalographic (EEG) and video data, a trained neurophysiologist in Berlin is able to analyse signals in real-time while data acquisition in London is ongoing. The system was designed and set-up by Pharmaimage in London including on-site training of staff and standard-operating procedures (SOPs). Additional sophisticated pharmacodynamic analyses of neurophysiological data streamed earlier are also conducted.

Evaluation of drug safety is the primary purpose of our real-time monitoring system. The monitoring system allows an early and highly sensitive assessment of potentially serious adverse events such as epileptic seizures or diffuse encephalopathic changes which in the worst case scenario may lead to coma and death. Accordingly, our monitoring system is particularly valuable when any drug, which affects brain function, is tested in clinical phase-I studies (first in human study) – most notably when dose escalation is conducted.

The newly created remote real-time monitoring system is considered as a prototype to be used for comparable clinical drug trials (phase-I/II) together with CROs and research hospitals all over Europe and beyond.

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