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ERT launches Phase 1 Site Certification Program to improve clinical development efficiency

ERT logo 2.4.18Clinical trials technology specialist ERT has launched a certification programme for Phase 1 investigative sites conducting cardiac safety studies. The programme trains sites to collect precise cardiac safety data so that trial sponsors and CROs can determine the cardiac safety of their compounds earlier in development.

The programme ensures sites are proficient in collecting the highest quality ECG data by conducting Phase 1 QT assessments using ERT’s proprietary Expert Precision QT (EPQT) approach. EPQT integrates the innovative and broadly-validated analysis methodology for obtaining highly precise ECG data originally developed by iCardiac Technologies, a company acquired by ERT in 2017, with the ERT EXPERT technology platform. Phase 1 units are trained by experts from ERT in deploying the same ECG/Holter acquisition technology utilised in iCardiac’s IQ-CSRC validation study, which provided evidence supporting the revision of ICH guidelines for testing cardiac safety earlier in development.

By scaling up the site certification programme, ERT has been able to expand upon elements previously offered by iCardiac and to enhance early-phase ECG data collection across a greater number of sites. Drug developers who work with sites already trained in collecting high-quality ECG data will therefore be able to better characterise the effect of a drug on the QT interval within the context of a routine Phase 1 trial, giving them greater confidence in making go/no-go decisions about compounds in the earlier stages of clinical development.

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Last modified onMonday, 02 April 2018 05:29