Biomarker Solutions


Safety during Clinical Phase-1 Studies

Serious adverse events (SAEs) during clinical phase-I studies (first dosing, dose escalation) are rare but can be devastating as exemplified by the recent incident at the clinical research organization (CRO) Biotrial in France or another incident during a trial that was conducted by the CRO Parexel (UK) in 2006.


In order to prevent at least some SAEs affecting brain function, Pharmaimage GmbH (Berlin, Germany) recently implemented a novel monitoring system. The system was tested in 2015 together with the CRO Hammersmith Medicines Research (HMR) in London (UK). To improve safety during clinical phase-I studies, the monitoring system was designed such that a highly sensitive assessment of SAEs affecting brain function such as epileptic seizures, diffuse encephalopathic (toxic) changes or strokes, which may lead to coma and death, is possible. When this kind of SAEs are detected early enough, further diagnostic and treatment intervention measures may prevent the worst case scenario. Accordingly, the Pharmaimage 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.

Pharmaimage GmbH has established a real-time neurophysiological/video monitoring system 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 elsewhere (e.g. in London) is ongoing. The system does not require particular expertise on-site at the CRU whereever it is located. Pharmaimage GmbH is providing and setting up the equipment for the duration of the study, Pharmaimage also provides on-site training of staff and standard-operating procedures (SOPs). Additional sophisticated pharmacodynamic analyses of neurophysiological data can also be conducted.

The newly established remote real-time monitoring system can be used as part of clinical drug trials (phase-I/II) conducted at CROs or research hospitals all over Europe and beyond.

Service Industry 4.0: Our novel real-time remote monitoring system is based on the concept of the "Internet of Things".

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