Perceptive Informatics, a subsidiary of PAREXEL International, has integrated its medical imaging technology with the functionality of DigiView, an image management and reporting system provided by Digisonics, to offer clients expanded capabilities for cardiac function assessment in clinical studies.
The system provides an electronic review, analysis, reporting and archiving of medical images related to cardiac function assessment, Perceptive said. Cardiac function assessment is required for a range of therapeutic area research, including cardiology, oncology, central nervous system and metabolism/endocrinology studies.
“As cardiac safety has become a greater regulatory focus for various compounds, biopharmaceutical companies increasingly turn to us for cardiac evaluations to support the demonstration of safety and efficacy,” said Todd A. Joron, corporate vice president and general manager of Perceptive.
The integrated Perceptive and DigiView system, which supports various cardiovascular imaging modalities, provides several capabilities, including faster, more accurate review of cardiac images as well as automatic synchronization of image analysis findings with other clinical data through an electronic case report form, according to the Boston-based Perceptive.
The company said its system provides an electronic record of all image analysis versions and exceeds HIPAA requirements for providing security and a regulatory audit trail, as well as capturing electronic signatures. Perceptive’s medical imaging technology is validated and in compliance with regulatory guidelines.