Independent Electrophysiology Data Auditing & Quality Control

Objective data verification and trace-to-table lineage audits for non-GLP in vitro and in vivo electrophysiology reports.

Trace-to-Table

Results linked to raw sweeps

Raw Acquisition Files

Independent Re-Analysis

Non-GLP Focus

Research & Pre-IND Standards

Data Referee

Unbiased Third-Party QC

Core Audit Focus

In Vitro & In Vivo Non-GLP Report Verification

We specialize in rigorous, independent quality control of non-GLP electrophysiology datasets. Our audits encompass, but are not limited to, raw binary trace extraction, baseline drift detection, signal-to-noise ratio verification, and inclusion/exclusion compliance. By ensuring your foundational data is uncompromised, we help you transition exploratory research into robust, inspection-ready packages for investor due diligence and Pre-IND submissions.

In Vitro Assays

Cellular & Ion Channel

Independent re-examination of raw voltage-clamp and current-clamp recordings to verify channel kinetics, pharmacology, and dose-response curve construction.

Manual Patch-Clamp (Whole-cell Voltage-Clamp & Current-Clamp, Single-channel)
Synaptic Transmission & Long-Term Potentiation (LTP)
Microelectrode Arrays (MEA)
Automated Patch-Clamp (APC)

In Vivo Electrophysiology

Systems & Circuit Level

Comprehensive verification of complex neural circuit data, field potentials, and chronic animal recordings to ensure artifact rejection and valid statistical aggregation.

Local Field Potentials (LFP) & Oscillatory Dynamics
Spike Sorting & Single-Unit Activity Audits
Peripheral Nerve Conduction Velocity
Electroencephalography (EEG) & Power Spectral Analysis

Collaborative Partners

Who We Work With

Serving as an impartial "Data Referee" across the life sciences ecosystem to validate non-GLP electrophysiological reports.

Multinational Pharma

Third-party verification for internal pipeline progression and high-stakes regulatory submission preparation. Eliminates internal bias before program advancement.

Small & Medium Biotech

Pre-IND data qualification and objective verification before out-licensing, partnering discussions, or key clinical development milestones.

VCs & Investors

Technical due diligence on electrophysiological claims, raw binary dataset integrity, and audit-ready risk assessment reports prior to investment.

CROs

Independent quality control and external data validation to reinforce client trust and ensure robust, high-integrity service delivery.

Academics

Validation of research novelty claims and standardized trace-to-table audit trails to support published non-GLP findings and grant requirements.

Audit Scope

Methodological Framework

Our multi-step verification protocols trace every data point back to original raw acquisition files and experimental lab records.

01 / LAB-BOOK AUDIT

ELN & Physical Records

Rigorous cross-referencing of Electronic Lab Notebooks (ELNs) and physical lab-books against raw data files, timestamps, and analysis scripts.

02 / RE-ANALYSIS

Raw Trace Extraction

Independent extraction and parallel re-calculation of raw hardware files (.abf, .dat, .h5) to verify peak amplitudes and time constants.

03 / EXCLUSION AUDIT

Exclusion Criteria QC

Testing discarded sweeps and omitted cells against pre-defined physiological standards to prevent selection bias and cherry-picking.

04 / TRACEABILITY

Trace-to-Table Lineage

Transparent, step-by-step documentation linking final results directly to raw acquisition sweeps.

ELECTROPHARMACOLOGY

Sample Audit Deliverable

REPORT ID: EPR-2024-CC-089

DATE: 17 Oct 2024

ASSAY: Whole-Cell Current-Clamp

VERDICT: UNCONFIRMED (RUN-UP ARTIFACT)

Executive Finding

Re-analysis of 8 continuous 30-minute .abf recordings revealed that the 3 reported "active responders" (37.5%) were caused by continuous baseline depolarization (+8.4 ± 2.1 mV run-up / seal degradation) rather than compound activation. The verified drug-mediated response rate is 0.0%.

Audit Metric Breakdown

Metric / Parameter	Original CRO Report	Audited Re-Analysis
Active Responders	3 / 8 cells (37.5%)	0 / 8 cells (0.0%)
Non-Responders	5 / 8 cells (62.5%)	5 / 8 cells (62.5%)
Baseline Potential Shift	Ignored / Uncorrected	+8.4 ± 2.1 mV continuous drift
AP Onset Latency	5–15 min post-drug	N/A (Drift-dependent run-up)
Membrane Stability QC	Not Evaluated	Failed (3 / 8 cells > 3 mV wander)

Trace-by-Trace Review Summary

Continuous Extraction: Re-examined raw .abf voltage-time series across the full 30-minute recordings rather than cherry-picked epoch segments.
Slope Projection: Pre-drug linear regression projected forward confirmed that all 3 "responders" were depolarizing prior to wash-on.
Threshold Crossings: Spontaneous action potentials occurred between 5–15 minutes purely as seal decay brought membrane potential to threshold.

Who We Are

Electropharmacology Leadership & Background

We are a team of seasoned electrophysiologists with a deep, battle-tested background spanning the pharmaceutical and biotechnology landscapes. Across decades of collective experience, we have designed, performed, and rigorously analyzed both in vitro and in vivo recordings using a wide array of advanced methodologies for multinational pharma, small-to-medium biotechs, and academic partners alike.

Simply put: we have seen it all.

Decades of Hands-On Mastery

True data integrity cannot be outsourced to automated algorithms or managed from a distance. Our two directors have personally spent a combined 70,000 hours in the trenches of electrophysiological research. That cumulative experience includes:

Executing complex experiments 'at the bench' and 'on the rig'.
Analyzing intricate datasets ranging from single-channel patch-clamp traces to multi-channel local field potentials (LFPs).
Drafting rigorous technical reports for high-stakes preclinical pipelines.
Acting as quality control managers overseeing junior staff to ensure flawless protocol execution and artifact elimination.

Your Impartial Data Referee

Having worked deeply within the industry, we understand the immense pressures surrounding non-GLP data, pipeline progression, and pre-IND milestones. We founded our practice to serve as an objective, independent "Data Referee"—bringing unmatched technical scrutiny to raw binary traces, eliminating selection bias, and ensuring that every conclusion you bring to investors, partners, or regulatory bodies is bulletproof.