Core Lab services
Since 1983, Cardialysis has gained experience as an independent Core Lab in clinical trials in cardiology. To date, we have been involved in over 400 clinical trials across the clinical development phases, including proof of concept, dose-finding, pivotal trials, as well as post-marketing registries 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 they are 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.
With the experience gained over the past decades, we advise in choosing optimal imaging and related logistic strategy to achieve your study objectives. Data from numerous clinical trials that involved Cardialysis have been used for competent authority submissions (including FDA, EMA, and PMDA new drug marketing approval applications and CE marking).
For all Core Lab techniques, Cardialysis provides site training and certification, including Acquisition Guidelines, WebEx training, and quality monitoring/ feedback to the investigational sites.
The quality of the Cardialysis Core Lab is guaranteed by (i) annual inter- and intra-observer variability testing (ii) utilization of reproducibility protocols (e.g., phantom analyses), (iii) regular review of the validation of the techniques, and (iv) regular training of Core Lab staff.
In addition, a test run as part of a Cardialysis SOP ensures high-quality output. At the Core Lab, the quality of the recording is assessed and if needed feedback to the site is provided to improve it. Every analysis is approved by either senior Core Lab staff or Core Lab supervisor.
The Core Lab techniques are validated to meet compliance with the latest international regulatory and industry standards:
- ISO 14155: 2011 (GCP)
- ISO 27001 (information protection)
- 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 Computed Tomography (CT) 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 modality-specific and study-specific database. This will be defined prior to the start of the study, taking sponsor requirements into account.