Product/Service

Cardiac Safety

Source: QuintilesIMS
Cardiac safety concerns can derail your promising product. Failure to evaluate and plan appropriately can leave signals undetected until later, larger studies — a costly scenario. And now regulators expect earlier, more accurate data.

Cardiac safety concerns can derail your promising product. Failure to evaluate and plan appropriately can leave signals undetected until later, larger studies — a costly scenario. And now regulators expect earlier, more accurate data.

Quintiles combines high-capacity, cost-effective ECG monitoring with drug development expertise. The result? You get the team you need to help you make better decisions, earlier — and meet regulatory expectations at each step of development from First-in-Human studies to regulatory submission.

We offer:

  • Real-time exchange of investigator data from anywhere
  • A proprietary, patent-pending system to flag, manage and quickly resolve data queries
  • An investigator and site helpline supporting 36 languages during ECG monitoring
  • Central reading standards that exceed ICH/FDA/EMEA guidelines
  • The industry's largest staff of cardiologists to review, analyze and adjudicate each ECG

Our ECG monitoring teams include biostatisticians, medical writers, regulatory specialists, data managers, clinical pharmacologists and highly experienced project managers. View other capabilities and services, including:

  • 12-lead Holter/3-lead Holter
  • ECG Web portal
  • Expert QT studies reporting