TQT Solutions
The increasingly complex regulatory environment has focused an intense spotlight on cardiac safety. You now have to produce more evidence with greater accuracy for the full spectrum of therapeutic areas. The more involved Thorough QT/QTc (TQT) study brings new challenges, and the timing is critical.
The earlier you can meaningfully test your drug's effect on the QT interval, the sooner you can make the go / no-go decision before investing in larger studies. And with new demands for evidence of cardiac risks for any drug, it's never too early to plan for cardiac safety.
You don't simply need help conducting the study; you need trusted guidance. That's where you can count on Quintiles. Anchored by leading cardiologists and scientists, our cardiac safety team brings together experts in every aspect of TQT studies. You can rely on their knowledge to help you design, conduct and analyze your study — to keep your product development moving forward.
Decisions around your drug's TQT study start with stringent regulatory requirements. So we assembled a team that mirrors the FDA's Interdisciplinary Review Team that evaluates all TQT study protocols and reports.
From medical officers to clinical pharmacologists to biostatisticians and data and project managers, we bring together medical and scientific experts for protocol review, study design and regulatory issues. With our integrated approach, you'll find all the expertise you need in one place.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.