Clinical 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.
For further information about ERT visit www.ert.com
Latest from Tom Mulligan
- Concept Life Sciences forms Scientific Advisory Board
- Sangamo finalises TxCell acquisition
- Polyplus-transfection introduces new nanoparticle DNA transfection reagent
- The 6th SGS Biopharma Day Seminar: a new early-phase clinical trials paradigm
- Blacktrace expands its presence in Japan with new office in Kanagawa
- MaSTherCell doubles production capacity
- Absolute Antibody expands production facilities
- Optibrium and University of Nottingham collaborate on innovative teaching programme
- Diamond Pharma Services wins both Futures and Support categories at TOPRA Awards
- Droplet microfluidics offers new approach for studying plant cell biomechanics