Clinical Research and Research Echocardiography

Protocol-specific transthoracic acquisition to sponsor-defined image sets. Standard and advanced measurements including left ventricular and left atrial strain, diastolic function grading, right ventricular assessment and valve quantification.

Screening, baseline and follow-up visit scanning. ECG, ambulatory ECG and ambulatory blood pressure monitoring where required by protocol.

Blinded independent review of study echocardiograms. Standardised measurement to a study-specific analysis manual. Inter- and intra-observer variability assessment on a defined sample. Query resolution and re-read on request. Across any sites covered, every study would be acquired and reported by the same accredited practitioner, removing inter-operator variability from that part of the dataset.

GCP-trained operator. Source data recorded to ALCOA+ principles with a documented audit trail. DICOM pseudonymisation and secure transfer according to agreed study arrangements. Protocol deviation logging and sponsor notification. Documentation prepared for sponsor monitoring and audit.

A costed schedule of our activity can be provided at feasibility stage, so that imaging is correctly attributed on the SoECAT and captured as a research cost rather than absorbed by the site. The constraints of research delivery — capacity gaps, competing clinical lists, and a visit window that does not move — are familiar ones.

The service is led by a practitioner working within a clinical research unit in experimental medicine, with experience of CTIMP delivery including early-phase immunotherapy trials, and a publication record in echocardiographic methodology covering left atrial mechanics and heart failure with preserved ejection fraction. Research imaging is a primary interest rather than an extension of a clinical service.