ICON Partners with iCardiac Technologies
News Nov 07, 2015
ICON plc has announced that its clinical research unit in San Antonio is a certified and preferred site in iCardiac’s Early Precision QT Program. The certification enables ICON to offer iCardiac’s Early Precision QT® services for evaluating the cardiac safety of new compounds in Phase I clinical trials. This solution provides clients with an earlier and more precise assessment of the safety risk of their drug and potentially eliminates the need for a separate Thorough QT (TQT) study in later stages of development.
Commenting on the announcement, Steve Unwin, ICON’s Executive Vice President, Early Phase Services, said: “We are looking to streamline the time and cost of early clinical development through our industry-leading technologies, agile and adaptive processes and by collaborating with industry partners who can bring new approaches to drug development. As an iCardiac Certified Site Partner, we can help our clients to assess the cardiac safety of their compounds earlier and more precisely which will enable them to prioritize clinical programs with strong safety profiles. In addition, more accurate early QT studies may eliminate the need for later stage TQT studies, saving our clients significant costs.”
Since 2005, the FDA has required all new compounds in development to be tested for cardiac safety. A dedicated TQT study determines the compound’s impact on the QT interval - the time between the start of the Q wave and the end of the T wave during the heart’s electrical cycle. A prolonged QT interval indicates a potential safety risk for a new drug.
TQT studies typically occur concurrently with Phase II or III trials however, the results of a prospective validation study, which was carried out in December 2014 through a collaboration between the FDA and Cardiac Safety Research Consortium, demonstrated that actionable cardiac safety assessments can be conducted in Phase I trials using ECGs collected during routine SAD or MAD studies. iCardiac Technologies’ Early Precision QT methodology was used in the validation study, which ICON is now certified to offer in clients’ SAD/MAD trials.
“ICON and iCardiac have frequently worked together on QT assessment studies, and that working experience has repeatedly confirmed the strong expertise that ICON possesses in ensuring that cardiac safety data of the highest quality is acquired during their Phase I studies,” said Alex Zapesochny, President & CEO of iCardiac Technologies. “We look forward to continuing to work closely with ICON to bring the many benefits of Early Precision QT to their clients.”