The ability to identify adverse cardiac effects is a crucial part of early drug development. CHDR offers a wide range of Good Clinical Practice (GCP)-certified diagnostic procedures that can be tailored to meet the needs of the sponsor and satisfy the regulatory authorities.

Highlights

  • CHDR has been monitoring cardiac function for more than two decades. These services are offered directly to our sponsors, eliminating the need for third-party ECG analyses.
  • Cardiology Services combines our in-house expertise in cardiology and internal medicine with experts at the Vrije University Medical Centre in Amsterdam and Leiden University Medical Centre.
  • Cardiology Services is cost-effective and highly informative, as the measurements are interpreted in the context of other study data.
  • Continuous 12-lead ECG (Holter) data can be collected from subjects who stay at CHDR's clinical research unit and from subjects who participate in a Trial@home study.

Summary

CHDR helps develop cardiovascular drugs and compounds that can affect cardiac rhythm and/or function. Together with clinical cardiologists at Vrije University Medical Center in Amsterdam (VUmc) and Leiden University Medical Center (LUMC), we can provide a full range of GCP-certified diagnostic procedures for analysing the effects of a test compound on cardiological function in both healthy subjects and patients. In addition to performing electrophysiology, we can also perform a wide variety of cardiac imaging techniques, including MRI and PET, all of which are provided in accordance with Good Clinical Practice (GCP) guidelines.

Overview of Cardiology Products and Services

  • Continuous Holter monitoring with 24-48 hour recorders
  • Echocardiography
  • Cardiac MRI and PET scanning
  • ECG recording and analysis (GE Dash 3000™ monitors and GE MAC® 5500 ECG machines)
  • Continuous telemetry
  • Reporting and submission of data
  • Data Management (a MUSE dedicated pharmacology database for ECG data recordings, and electronic storage and upload formats compatible with the ECG Warehouse)

One-stop-shop

CHDR’s Cardiology Services® provides our sponsors with ‘one-stop shopping’ for all of their cardiology needs. Cardiology Services provides a wide range of cardiovascular diagnostic procedures for the early stages of clinical drug development. The benefits are clear: because we already use high-quality ECG to ensure the safety of our subjects, it is relatively easy to perform additional analyses as needed in order to rule out possible adverse effects and/or study the compound’s effects on cardiovascular function.  Prof. Burggraaf:

It's more practical and more time-efficient; and because there’s no intermediary involved, costs are reduced. Of course, these are important considerations. But as both a pharmacologist and a scientist, I think it's even more important to have all the pieces of the puzzle in one place. So when I interpret a subject’s ECG, I can do so within the context of this particular subject at this particular time and place. That's why I strongly believe that we now provide considerable added value by combining early-stage drug development with our comprehensive cardiology service. This integrated approach ensures that we have all the important data in one database, ready to be added to the trial dossier.

Trial@home

CHDR’s Cardiology Services also uses our Trial@home approach to study the drug’s effects while subjects go about their daily business. Using non-invasive wearable devices that record a variety of parameters, including heart rhythm, movement, and body temperature, CHDR can perform studies while the subject is at home, at work, and at play. These devices can also be used to monitor subjects during the ‘washout phase’ of a drug trial, during which the compound is cleared from the body, thereby providing important information regarding the compound’s long-term effects on heart function and other physiological properties.

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