Biomarker Solutions

Specific services offered by PI

Services are offered as modules which can be customized:

Electrophysiology (EEG/ERP) hardware/software is provided to conduct EEG/ERP experiments at the clinical study site (any CRO/hospital in Europe or beyond). On-site technical training of local staff (e.g. study nurses) is provided if needed by Pharmaimage to conduct the electrophysiological (EEG/ERP) experiments. Quantitative (pharmacodynamic) EEG/ERP data analyses (e.g. power spectra, time-frequency analyses, source analyses) are conducted in Berlin. Pharmaimage recently also developed a novel EEG monitoring system for safety assessment during/after dosing/dose escalation e.g. for early detection of seizure activity (e.g. with glutamatergic compounds) or toxic encephalopathy. While the Pharmaimage EEG monitoring equipment can be located at any CRO/hospital (worldwide), the clinical EEG assessments are conducted in real-time (remotely) in Berlin by a certified clinical neurophysiologist (pharmaco-EEG expert). Safety monitoring data can be simultaneously used for pharmacodynamic measurements (e.g. surrogate outcome measures).

For more information see: Imaging & Electrophysiology Biomarkers

Neuroimaging experiments (fMRI, structural MRI) are conducted using MRI-scanners near the clinical study site. Scanner time is rented by Pharmaimage on-site (in the proximity of the CRO or hospital where the clinical study is conducted), Pharmaimage provides MR-sequences and staff (technical assistants/physicians) are trained on-site if required. Imaging data analyses (e.g. event-related/task-related, resting state fMRI, volumes of hippocampus or cholinergic nuclei) are conducted remotely in Berlin.

Drug challenge imaging paradigms (ketamine/nicotine) are also established. These paradigms allow testing of novel compounds whether they counteract or mimick the brain function resulting from the challenge drug.

Simultaneous fMRI/EEG experiments combining the sensitivity of EEG with spatial accuracy of MRI are possible, too.

Additional physiological measurements (ECG, skin conductance), tailored stimulation paradigms (e.g. cognitive, photic stimulation) can also be provided.

All electrophysiological or neuroimaging data are transferred securely from the study site to Pharmaimage in Berlin where data analyses are conducted.

For more information see: Imaging & Electrophysiology Biomarkers


The Pharmaimage hardware below can be delivered to the clinical study site (e.g. CRO)

Electrophysiological investigations:

  • 4 complete EEG-recording BrainAmp DC 32-channel systems with 4 recording dongles, 4 laptops and 4 EasyCaps 32-channels

  • 2 LED Photic-Light Stimulators with trigger box compatible to BrainAmp EEG recorders

Simultaneous fMRI/EEG investigations:

  • 1 complete MR-compatible EEG-recording BrainAmp MR Plus system (32 channels) with 2 recording dongles, 2 laptops, 4 BrainCaps MR, 2 syncboxes

*For stimulus delivery (auditory, visual), Presentation® software is used.

Endpoints/software standard packages:

Electrophysiology endpoints:

  • EEG (resting state/event-related): power spectra, coherence, time-frequency (e.g. gamma, theta oscillations, signal-to-noise ratio) incl. source analysis

  • ERPs: P50, N100, P300, MMN incl. source analysis

  • Additionally requested parameters are possible

Software: BrainVision Analyzer 2, BESA, sLORETA

Imaging endpoints (fMRI):

  • Resting state, block design, event-related

  • ROI, whole-brain voxelwise

  • Functional connectivity analyses (seed-based, independent component analysis incl. default mode network analyses)

  • Additionally requested parameters or MR sequences (e.g. perfusion) are possible

Software: Statistical Parametric Mapping (SPM12)

Imaging endpoints (structural MRI):

  • Sequences: MPRAGE, T2-SPACE, T2 (High-Res)

  • Whole-brain voxel-based morphometry, volume-based incl. subfield analyses (e.g. hippocampus, Ncl. Basalis Meynert), surface based analyses

Software: Freesurfer, DARTEL Toolbox

Additional services:

  • Formal support with biomarker studies incl. clinical trial protocols, study proposals for industry, ethics applications
  • Administration/coordination of projects
  • Study set-up incl. on-site installation and maintenance of hardware/software for physiological/imaging measurements incl. on-site training of staff, logistics (storage/transport), contracting imaging facilities for data collection
  • Clinical data management incl. standard operating procedures (SOPs), electronic case report forms (eCRFs), transfer via cloud service
  • Monitoring, registration of drug trials, supporting import/export of experimental drug substances for research requiring import and/or export authorizations
  • Clinical data (statistical) analyses, electrophysiology/imaging data analyses
  • Reporting (final reports, SAE reporting)
  • Legal activities, negotiations, consortium agreements, intellectual property (IP) protection, contacting legal bodies (e.g. EMA)
  • Dissemination activities, project web sites, public awareness of projects, organization of meetings and events, training activities

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