TQT (Thorough QT) & QTc Studies

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.

• ECG Core Lab
• Cardio Analysis Services
• ECG Analysis