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Neuromap

Central EEG Analytics for Protocol-Driven Studies

Central EEG and qEEG Analytics for Clinical Trials

Neuromap supports sponsors, CROs and research units with protocol-configured EEG quality control, advanced quantitative analysis, longitudinal comparison, specialist scientific review and study-ready data outputs.

Clinical trials may collect EEG across multiple participants, visits, devices and sites. Without a harmonised analytical pathway, variability in acquisition, metadata, preprocessing and reporting can limit interpretability. Neuromap provides a centralised workflow designed to improve consistency, document exceptions and deliver structured outputs aligned with the protocol and analysis plan.

Supported study contexts

  • Phase I and first-in-human studies.
  • Healthy-volunteer studies.
  • Phase II and Phase III exploratory EEG programmes.
  • Single-site and multi-centre studies.
  • Crossover, repeated-measures and adaptive research designs.
  • Baseline, pre-dose, post-dose, follow-up and extension assessments.
  • Investigator-initiated and academic-industry studies.
  • Medical-device, digital-therapeutic, rehabilitation and neuromodulation research.
  • Retrospective EEG dataset analysis and methods-development projects.

Support across the trial lifecycle

Protocol planning

Translate the research question into technically achievable acquisition requirements, variables, comparisons, quality thresholds and deliverables.

Bid and feasibility

Review requests for proposal, expected volume, site configuration, analysis complexity, review level and delivery assumptions.

Study setup

Define file naming, metadata schema, transfer route, quality rules, analysis version, exception management, access controls and release process.

Production analysis

Apply the approved configuration consistently to eligible recordings and maintain traceable processing and issue records.

Milestone review

Provide data-quality summaries, longitudinal outputs, planned interim deliverables and documented limitations.

Study close

Deliver final approved datasets, reports, methods information, quality documentation and agreed archival materials.

Clinical trial service modules

Study feasibility review

Assessment of equipment, format, montage, sample rate, recording duration, conditions, event markers, metadata, expected volume and intended variables.

Acquisition guidance

A study-specific EEG acquisition and metadata specification designed to improve comparability across participants, visits and sites.

Central data quality control

Consistent checks for recording completeness, channel integrity, signal quality, artefact burden, timing, metadata and protocol deviations.

Configured qEEG analytics

Generation of prospectively selected quantitative variables relevant to the scientific objectives and supported by the available data.

Longitudinal comparison

Consistent processing for baseline, treatment, post-treatment and follow-up visits, with predefined change variables and exception rules.

Candidate biomarker analysis

Exploratory evaluation of EEG-derived variables and biomarker hypotheses. Outputs are not described as qualified regulatory biomarkers unless formally established.

Specialist scientific review

Review of agreed recording-level exceptions, quantitative outputs, cohort findings and interpretation boundaries.

Structured data delivery

Approved numerical variables, data dictionaries, quality flags, tables, figures and machine-readable exports.

Study-level reporting

Milestone or close-out summary of data quality, analysis completion, predefined trends, limitations and unresolved issues.

A core-laboratory model without forcing a single acquisition system

Neuromap can assess technically suitable recordings produced by different EEG systems, provided the format, montage, sampling, reference, duration, event information and quality meet the agreed study specification. A device and site compatibility matrix is created during feasibility. Where cross-system differences could compromise comparability, the limitation is documented and the analysis plan is adjusted before production.

Quality by design

Quality requirements are defined before analysis rather than applied retrospectively. Critical-to-quality factors may include acquisition state, usable duration, electrode coverage, reference, sampling rate, filter history, timing relative to dose, event markers, participant state, medication information and protocol deviations. The study configuration records which variables can be generated, which exclusions apply and how exceptions are escalated.

Longitudinal and pharmacodynamic research

Repeated EEG can be used to examine within-participant and group-level change across controlled timepoints. Neuromap can support baseline stability assessment, pre-dose to post-dose comparison, dose-level trajectories, crossover-period analysis, follow-up durability and exploratory responder classification. Statistical models and inferential testing remain subject to the approved statistical analysis plan and qualified biostatistical oversight.

Research enhancement and intervention-comparison designs

For ethically approved intervention studies, Neuromap can compare EEG-derived variables before and after a defined programme and relate change to functional, cognitive, behavioural or performance outcomes. The service can support comparisons between study arms, intervention intensities, delivery models or sequential phases, provided the design, confounding controls and analysis plan are appropriate.

Study-ready deliverables

  • Recording-level QC status and exception flags.
  • Configured quantitative variables with data dictionary and units.
  • Visit-level and participant-level longitudinal comparison tables.
  • Cohort and subgroup descriptive summaries.
  • Publication-quality figures and accessible underlying tables.
  • Methods and analysis-configuration documentation.
  • Specialist-reviewed recording or study reports where contracted.
  • Secure recorded interpretation for authorised study teams where agreed.
  • Close-out report and agreed archival package.

Governance for UK clinical-trial work

For UK clinical trials of investigational medicinal products, the sponsor retains responsibility for oversight and for ensuring that delegated activities are appropriately qualified, documented and controlled. Neuromap’s delegated tasks, quality controls, access permissions, records, issue management, audit support, data handling and escalation routes are defined in the contract and study documentation. The service is designed to support risk-proportionate workflows consistent with the applicable Clinical Trials Regulations and ICH E6(R3) Good Clinical Practice, without claiming sponsor or regulatory responsibility.

Start with a controlled feasibility review

Provide the study synopsis or relevant protocol sections, EEG manual, schedule of assessments, expected volume, equipment details and required outputs. We will identify compatibility, missing information, material risks and the appropriate pilot or production pathway.

Frequently asked questions

Common questions about EEG and qEEG analytics for clinical trials.

Can Neuromap join a study before the protocol is final?

Yes. Early involvement allows acquisition requirements, metadata and analytical feasibility to be addressed before site initiation.

Can different EEG systems be used across sites?

Potentially. Each system and configuration must be assessed. Cross-system comparability cannot be assumed and may require harmonisation, stratification or limitation of selected analyses.

Can Neuromap act as the clinical EEG reader?

The website service is a research analytics service. Clinical EEG interpretation or safety reading requires a separately defined pathway, responsibilities and appropriately qualified clinical professionals.

Can outputs be used as a regulatory endpoint?

Only if the endpoint, method, validation, qualification and regulatory strategy support that use. Standard research outputs must not be represented as qualified regulatory endpoints.