Cardialysis, a specialist clinical research organisation (CRO) with headquarters in Rotterdam, the Netherlands, has engaged US-based quality-compliance partner AG Mednet as its preferred provider for image-data submission and collection in clinical trials.
The Dutch company provides a full range of clinical-research and cardiac core-laboratory services through a network of more than 1,200 sites worldwide, with an exclusive focus on cardiology.
Cardialysis pointed to the need for speed, efficiency and accuracy as crucial success factors in clinical trials.
With large amounts of data collected, and significant leeway for data-submission errors, “there is even greater potential to disqualify participating patients or expose subjects to unnecessary risky procedures due to data errors”, it noted.
AG Mednet provides the functionality and support to collect clinical-trial image data globally; to de-identify these data in line with regulatory requirements; apply advanced, automated quality-assurance processes to ensure the data are protocol-compliant and readily usable; and deliver the data reliably and securely to one or more trial repositories.
“With Cardialysis, we're working on cardiology-related studies with two major medical device companies and more than 1,000 participating patients,” said Abraham Gutman, president and chief executive of AG Mednet.
“We are passionate about working with organisations that are leading the industry in a positive direction, and we see Cardialysis as doing exactly that.”
Working with AG Mednet means significant efficiencies and convenience for participating clinical sites, pointed out Teun Smits, Cardialysis’ manager for business development.
As such, “we expect even further improvement in the quality of the data collected and transferred compared to past trials”, Smits added.
Electronic data submission and collection would contribute to Cardialysis’ goal of becoming a fully functioning eCRO, he observed.