Core-Lab Agility Key To Study Success

Although a relatively young company, MyCardium’s specialization in advanced AI-enhanced analysis of cardiac images has already brought it to the attention of some of the world’s leading developers of new treatments for cardiac diseases and conditions. MyCardium’s Core Lab Services combine internationally recognized expertise with the enhanced accuracy, precision and consistency, delivered by their proprietary AI. They have already proved pivotal in safely bringing new drugs to market much more rapidly and economically than has previously been possible.

However, sometimes analysis is not the only service that MyCardium are called upon to provide. Developing new therapies for rare diseases brings its own unique problems, not least the shortage of eligible participants, the availability of suitable local expertise and appropriate equipment. MyCardium was recently called upon to provide support to a major sponsor and their Clinical Research Organisation (CRO), to resolve issues with the onboarding of a site and potential participant in a groundbreaking rare disease clinical trial. Initial CMR test images, provided by the local clinic using their scanner did not meet the quality requirements of the CRO despite multiple attempts and the problem looked intractable. Given recruitment constraints, both the sponsor and their CRO were understandably keen to retain the site and the participant as part of the clinical trial.

One of MyCardium’s specialist radiographers, Jane Francis, carried out detailed research into the capabilities of the site’s MRI scanner, reviewed the ‘failed’ images with the corresponding data provided against the imaging charter and guidelines and contacted the site. She quickly established that the equipment, allied to the experience and capability of local personnel should have delivered acceptable results, but hadn’t. It was rapidly apparent that a site visit was required, and Jane boarded a flight. Once on site, working closely with the local radiographer and the CRO, she was able to establish that, although there was solid cardiac MRI experience and expertise, there were some minor issues with the scanning protocols and data entry available on the scanner as well as understanding of the imaging guidelines and the CRO’s application of their quality control. Once each of these had been addressed, and with some additional small changes to the scanning procedure, the site’s next scan passed the CRO’s Quality Assurance tests and both they and the trial participant have been onboarded to the study programme.

Professor James Moon, MyCardium’s Chief Executive said ‘This great result comes directly from an ability to identify problems and to deliver multi-faceted solutions. Exceeding our clients’ expectations in order to support them in meeting their objectives is the central philosophy of our Core-Lab business’.