Use your data collected during routine Phase I studies to assess cardiac safety early in drug development. Sufficient data will now be reviewed by the FDA and other regulators under the 2015 E14 Q&A document and may enable the FDA to grant a waiver of the traditional full TQT study based on early response analysis of the investigational product’s QT characterization.
This technique, has multiple benefits for biopharmaceutical client:
- Utilizing Early Precision QT offered by our partner iCardiac, can potentially save millions of dollars vs a traditional full TQT study
- Confirm or clarify an earlier in vitro or in vivo non-clinical cardiovascular safety finding
- De-risk a compound and increase the potential value of the development program prior to Phase II studies
- Rank order potential analog compounds in a library to bring forward the candidates with fewer cardiovascular risks into development
We are a proud member of the Cardiac Safety Research Consortium have completed the iCardiac training and certification process and are Implementing Early Precision QT assessments in early stage studies conducted at our facility.