Digital ECG Analysis and Cardiologist Experience

Richmond Pharmacology provides their clients with FDA compliant manual over-read QT interval measurement and analysis by a team of highly trained and experienced cardiologists.

Using the FDA compliant manual over-read approach, the QT interval is measured by our cardiologists on screen using electronic callipers (MUSE CV® Interval Editor, GE Marquette Medical Systems) with sufficient magnification allowing the measurement precision equal to the storage frequency of 500 MHz, i.e. ±1 ms. Whilst the details of the analysis can be discussed and agreed with our clients at the study design stage, as a matter of routine, in each ECG the QT interval is measured in all 12 leads. The median QT interval of all measurable beats from the 12 leads is then taken as valid for that particular ECG.

The measured and verified QT intervals are corrected for heart rate using conventional population-derived formulae (e.g. Fridericia) or an individually derived formula. The QT/QTc interval data are then subjected to a statistical analysis in accordance with the current regulatory guidelines which also includes input and interpretation of the results from one of our experienced cardiological scientists.

In line with the current regulatory requirements and at least every six months, all cardiologists working for Richmond Pharmacology undertake intra- and inter-reader variability tests under blinded conditions to ensure that our measurements are accurate and reproducible. Furthermore, systematic in–process QC checks are performed by a senior cardiologist during a specific study analysis. All QC checks and any corrective actions are reconciled and fully documented.

Richmond Pharmacology’s Core ECG Laboratory team are based within St George’s Hospital Medical School, London and are made up of highly experienced cardiologist’s headed by Professor John Camm, a key opinion leader in TQT Trials.

Our experts

Professor Camm - Professor of Cardiology

Professor Camm's major speciality is cardiac arrhythmias but he is also much involved in clinical cardiac electrophysiology, cardiac pacemakers and risk stratification in post myocardial infarction, heart failure and cardiomyopathy drugs.

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Dr Jorg Taubel - MD FFPM
(CEO)

Medical practitioner and CEO of Richmond Pharmacology which he co-founded in 2001. He has worked in pharmacology for 24 years and during that time he has conducted more than 400 early phase studies in patient, paediatric and healthy volunteers.

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Experience

  • Track record of 100% success in conducting QTC studies
  • Many of our QTc studies have been published.

Set-up

  • State of the art methods and equipment
  • Tried and tested processing for ECG adjudication and data analysis

We are

  • Excellence in ECG acquisition allows meaningful ECG analysis
  • Option to include a non-pharmacological method of proving assay sensitivity

Latest news

Upcoming Event

EUFEMED, 3rd Annual Conference, 28-30 April 2021

28-30 April 2021
Dr Jorg Taubel will co-chair a session on day one, which explores how technology has reduced the risks of pandemic effects on Phase I and II trial performance.
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Do we still need challenge trials with COVID-19?

April 21, 2021
Nir Eyal and colleagues suggested that the initiation of COVID-19 challenge trials in response to the UK governments’ call in 2020 remained relevant and important despite the development of approved vaccines and the introduction of an aggressive, UK-wide vaccination policy.
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Novel rate-controlled fentanyl patch shows promise in phase I clinical trial

April 1, 2021
Our expertise in ethnic differences and access to over 12,000 first generation Japanese volunteers accelerated our ability to provide robust clinical trial data to support future applications of new chronic pain medicines to the Japanese drug market.
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A new era for UK-Japanese scientific relations

March 23, 2021
Dr Taubel uses his experience of conducting more than 60 Japanese bridging studies to explain why the deal is of strategic importance to the UK and highlights the scientific requirements for conducting successful Japanese trials abroad
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