29.02.2016

HMR and iCardiac Technologies Inc become partners

HMR offers high-precision QT measurement as a cost-effective alternative to thorough QT studies.

In November 2015, HMR completed the iCardiac Site Certification Program and officially became a preferred site for iCardiac Technologies Inc, so we can now offer Phase 1 studies with a High-precision QT schedule.

Substantial savings for sponsors, and early information on potential to prolong QT, can be gained through using iCardiac's High precision QT schedule as an alternative to a thorough QT study (Darpo et al., 2015). That strategy has now been formally accepted for regulatory submission (December 2015 update to the ICH E14 guidance for industry).

For more information, please email hmr@hmrlondon.com.

References:

• ICH Topic E 14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• The New Standard For Cardiac Safety: Early Precision QT from iCardiac
• Landmark Regulatory Revision Ushers in an Alternative to the Thorough QT Study

---

Back to list