Cardiac Imaging Core Lab

• Two-step verification: All images analyzed by our sonographers are verified and finalized by a qualified physician.
• Rigorous quality check of data-entry: All data entered into the EDC is checked by a second CICL staff member to ensure they match with that entered into the PACS system and are error-free.
• Control for inter/intra-operator variability: We periodically assess measurements by our sonographers, and retrain them if necessary, to mitigate variability in measurements that impact study data.
• Turnaround time: Complete analysis of screening cases in 24-36 hours, and follow-up images in 72 hours, on average.
• Capacity: Standard support analysis of several thousand images per year with ability to expand staff as needed.
• Compliance with industry regulations: FDA Regulations, FDA Guidance for Industry (Computerized systems and Electronic Source Data in Clinical Investigations) and ICH-GCP E6, ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects).

As part of Baylor Scott & White The Heart Hospital – Plano, our Core Lab is guided by an expert senior leadership team of world-renowned cardiac surgeons and cardiologists with extensive expertise in directing image-related research studies and leading numerous national and international trials.

Michael Mack, MD

J. Michael DiMaio, MD

Robert L. Smith, MD

William Halsell Ryan, MD

Molly Szerlip, MD

Zuyue Wang, MD