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Core Laboratories

The ECG and Imaging Core Laboratories at the Duke Clinical Research Institute (DCRI) provide cardiac safety services for Pre-Human, First-in-Man, Phase I, Phase II, Phase III, and Phase IV clinical trials. This web site is dedicated to providing you with information about these services, as well as our academic mission, which is manifest through the unique services that we provide.

All of our studies are supported by the thought leadership and regulatory guidance of board-certified, Duke University faculty physicians. All of our studies are 100 % overread by Duke faculty cardiologists. The collective expertise of our core labs' physicians encompasses all forms of electrocardiogram (ECG) evaluation and cardiovascular imaging. Our core labs' physicians are widely recognized as industry and academic leaders in novel medical product development and have experience with product development in all major therapeutic areas. Several physicians who comprise the thought leadership of our core labs serve on panels or the advisory committee at the FDA. This direct relationship with regulatory authorities ensures that our labs will provide your company with up-to-date, accurate, and informed guidance as you consider the future of your company's compound, drug, or device.

The ECG Core Laboratory at the DCRI offers a unique blend of ECG analysis, platforms, and software systems. Led by the expertise of Dr. Mitchell Krucoff, Director of Caridac Safety ECG Services, the ECG Core Lab provides the gold standard in ST recovery analysis, arrhythmia diagnosis, and cardiac safety monitoring.

The Imaging Core Laboratory at the DCRI began by providing echocardiography services for clinical trials. However in recent months, under the direction of Dr. Pamela Douglas, Director of Cardiac Safety Imaging Services, the Imaging Core Lab has expanded its services to now include cardiac nuclear imaging, cardiac magnetic resonance imaging (MRI), cardiac computed tomography (CT) imaging, quantitative coronary angiography (QCA) imaging, and intima-media thickness (IMT) evaluation through atherosclerotic imaging.

In conjunction with DCRI, our core labs offer a full-service clinical trials package by providing study start-up to close-out services, inclusive of protocol development and design, quality assurance, logistic and technical support, data interpretation and analysis, report preparation, global study management, regulatory strategy and consultation, statistical support, and data management.

We hope to partner with you and your company as we strive to encourage the growth and development of life-altering and life-saving medical compounds and devices.

History
Leadership and Faculty
  Dianne Cheesborough
  Pamela Douglas
  Cynthia Green
  Mitchell Krucoff
  David Whellan
 
ECG Core Laboratory Services
Imaging Core Laboratory Services
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