TQT (Thorough QT) & QTc Studies

Richmond Pharmacology has a globally well recognised expertise in providing consultancy on cardiac safety, the conduct of intensive ECG studies, the cardiology over-reading, statistical analysis, reporting and publishing. We can conduct "stand-alone" TQT studies or combine this with Japanese bridging and or early SAD and MAD studies.

Benefits of using Richmond Pharmacology

Short start-up times of 4-6 weeks; rapid data readouts

Focused on excellent ECG generation facilitating ECG over reading

Known to regulatory agencies in EU, USA and Japan

We are fully versed about the latest requirements in cardiac safety

Low data variability allowing for the use of smaller sample sizes


Thorough and intensive QTc Studies

Richmond Pharmacology has a globally, well recognised expertise in providing consultancy and expert reports on cardiac safety, the clinical conduct of intensive ECG studies, core laboratory services such as adjudication and the cardiology over-reading of automated interval measurements. We have expertise in statistical analysis concentration-effect modelling (CEM), reporting and publishing. We have a 10 year track record in conducting QTc studies. We can conduct ICH E14 TQT studies or use CEM during Japanese bridging and/or early SAD and MAD studies eliminating the requirement for a dedicated TQT study.

Richmond Pharmacology provides their clients with FDA compliant state of the art analysis methods, and provides the option to include a non-pharmacological method of proving assay sensitivity. Richmond’s unique and innovative approach means that we conduct our studies and prove assay sensitivity as a standard feature. This has provided quality data in many non-TQT studies eliminating the need for a dedicated TQT study.

Unmatched expertise

Our core ECG laboratory provides a centralised system for all our studies. It has the longstanding commercial, clinical and academic reputation of excellence of St George’s University in London, a world class provider in cardiology. High-precision ECG acquisition in our tried and tested clinic allows meaningful ECG analysis with a smaller sample size, making us the ideal choice for the integration of cardiac safety in FIH and MAD studies.

Richmond Pharmacology’s clinical facilities and the on-site core lab are a permanent set-up offering an unmatched focused work environment with no additional costs, thereby delivering value for money to pharmaceutical Sponsors. We are a leading publisher in this area and have publicly accessible credentials. We are proud of our integrity, our professional growth and experience in this field.




Richmond Pharmacology develops optimal and cost-effective strategies for TQT waivers

All QTc studies are performed in collaboration with world renowned opinion leaders in cardiological analysis

Richmond Pharmacology study data is well respected by regulators such as FDA, EMA and PMDA

Our experts


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.

View Professor Camm's profile ›
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.

View Dr Jorg Taubel's Profile ›

Experience

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

Set-up

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

Cardiac safety integration in FTIM and MAD Studies

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

More about our Thorough QT Studies below


RPL's ECG Core Lab

Richmond Pharmacology's Core ECG Laboratory was established in 2004 to provide centralized digital and manual ECG data analysis for Richmond Pharmacology's in house TQT trials, in addition to ECG reading, analysis and reporting for clinical trials.

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Why Choose RPL for TQT Studies

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.

Our Cardio Analysis Services

Richmond Pharmacology's Core ECG Laboratory has worked with numerous clinical units worldwide and participated in 200 clinical trials sponsored by pharmaceutical companies.

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Digital ECG Analysis and Cardiologist Experience

Thorough QT/QTc (TQT) studies are today an integral component in the development of new chemical entities (NCE) and on going drug development programmes.

Read more ›



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