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QT Evaluation in Early Clinical Development Thomas Todaro, MD, JD, FACC
Medpace Vice President, Medical Affairs

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Medpace is a full and active member of the Cardiac Safety Reserach Consortium. The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through a MOU with Duke University to support research into the evaluation of cardiac safety of medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, “Think Tank Incubator” programs, and consensus white papers.

Medpace is home to renowned regulatory and therapeutic experts who are committed to the complex and intertwined therapeutic areas of cardiology.

With extensive experience in Phase I-IV research, our team of international therapeutic leaders have dedicated their careers to bringing drugs to market that treat or prevent heart disease. In fact, they have helped pioneer many of the preventative cardiovascular compounds introduced in the last 15 years.

Medpace regulatory experts are former government officials who have invaluable insight into the specific area of cardiovascular drug and medical device approval. They are an integral part of every study and their valuable guidance ensures every step efficiently accelerates the approval process.

Medpace experience in large cardiovascular endpoint trials

The Medpace ability to integrate cardiovascular trials with metabolic/endocrinology projects across both therapeutic and regulatory knowledge bases provides sponsors with unique capabilities for large studies demanding rigorous safety requirements. Electronic endpoint adjudication capabilities coupled with strategic consultation and management of all outcomes and regulatory requirements, keeps projects on track.

Therapeutic Categories

  • Acute coronary syndrome
  • Coronary artery disease
  • Hypertension
  • Stroke
  • Heart failure
  • Atherosclerosis
  • STEMI and non-STEMI

>> Click here to learn more about Medpace's capabilities and therapeutic expertise in cardiology.