Core Lab services
Since 1983, Cardialysis has a lot of experience as an independent Core Lab in clinical trials in cardiology. To date, we have been involved in over 400 clinical trials varying from phase II and phase III, registry, post-marketing trials and investigator initiated studies. Continuous innovations and the application of imaging modalities in different settings such as animal research have made Cardialysis the successful provider of Core Lab services that it is today.
Leading experts in the field of cardiovascular imaging supervise Cardialysis’ Core Lab activities. We guarantee independent and accurate central analysis according to the latest standards of definitions.
With the experience we have gained over the past decades, we can provide excellent advice in choosing the required imaging and related logistical strategy to achieve your clinical development objectives. Data from numerous clinical trials in which Cardialysis has been involved have been used for competent authority (e.g. FDA, EMA and CE mark) submissions.
For all Core Lab techniques, Cardialysis provides site training and certification, including Acquisition Guidelines, WebEx training and hands-on workshops in Rotterdam.
The quality of the Cardialysis Core Lab is guaranteed by a quality assurance system in which both inter-observer variability and intra-observer variability are tested yearly. Reproducibility protocols including phantom analyses are other important tools to ensure the quality of the Core Lab. Regular review of the validation of the techniques and the training of Core Lab staff complements the system.
A test run is part of a Cardialysis SOP ensuring high-quality output. At the Core Lab, the quality of the recording is assessed and feedback to the site is provided to improve the quality. Every analysis is approved by either senior Core Lab staff or supervising cardiologists.
The Core Lab techniques are validated to meet compliance with the latest international regulatory and industry standards:
ISO 14155: 2011 (GCP)
GCLP endorsed by WHO: 2009
FDA 21 CFR part 11: Electronic Records; Electronic Signatures
Cardialysis uses an in-house state-of-the-art data processing system that accepts both electronically or physically shipped Core Lab material in standard DICOM format or specific formats such as those pertaining to 3D Echocardiography and Optical Coherence Tomography (OCT). The system accepts virtually all digital output of equipment from major vendors without storage restrictions.
The Cardialysis Core Lab uses validated and vendor-independent software packages that are compatible with most commercially available imaging vendors. Core Lab analysis output is digitally transferred in a technique and study specific database. This will be defined before the start of the study, taking sponsor requirements into account.