Mortara Announces Enhanced ECG Warehouse Service Offerings
Mortara Instrument, the architect and service provider of the ECG Warehouse, announces enhanced service options for the upload and validation of ECG data for FDA review. With nearly 9 million ECGs in the ECG warehouse, and a growing demand for digital ECGs in clinical trials, there is an ever increasing volume of requests for data upload.
The standard upload process involves multiple steps, including filling out the upload request form at www.ecgwarehouse.com, providing a sample data set to verify proper data formatting, importing the data, assigning permissions to appropriate personnel and initiating the data upload process in conjunction with ECG Warehouse Administrators. The time to complete a study submission (from Upload Request to granting FDA access) can vary and depends on the study type, size, and the number of other studies being processed.
If timing is critical to your study evaluation, and unpredictable submission timelines are simply unacceptable, Mortara now has a faster solution! We are pleased to introduce our new, expedited Priority Service Upload program. The charge for this expedited service option is $5,000 per ECG study submission.
If you are interested in either the Priority Service Upload or ECG Study View, please inquire today with a Mortara Service Representative (414-354-1432) or email info @ ecgwarehouse.com. Please specify which party is to be invoiced for these services and provide a purchase order to initiate any of these service offerings.
Ensuring Your Data is Ready for Digital Submission
The E-Scribe ECG Warehouse data upload process features a validation step to review all annotated ECGs for adherence to the HL7 annotated ECG standard. Annotated ECGs not meeting the standard are not imported into the E-Scribe ECG Warehouse and a detailed report of non-conformance is generated. Using the E-Scribe ECG Warehouse in advance allows identification and resolution of non-conformities to reduce potential delays in the review process.
Web Based Review Toolset
Using the same review tools developed with the FDA, Mortara E-Scribe ECG Warehouse users can review annotated ECG studies before application submission. The web based toolset provides full viewing of the annotated ECGs in a secure, enterprise wide deployable solution. Advance viewing of annotated ECGs with the E-Scribe ECG Warehouse enables review of ECG data beyond the confines of the central laboratory and can help to identify potential issues prior to data lock.
Study Statistics and Performance Metrics
The E-Scribe ECG Warehouse utilizes Mortara VERITAS TM algorithms to quantitatively assess annotated ECG data sets. Measures of both analysis and signal acquisition quality are available to provide comparative metrics associated with central laboratory ECG processing and investigator site ECG acquisition. These metrics provide valuable quantification of study statistics and can be used prior to submission to identify ECGs of potential interest for further review as well as a basis to evaluate different studies processed by different central laboratories.
Long Term Digital ECG Archiving Solution
Valuable annotated ECGs need to be properly archived for future access and possible research. The E-Scribe ECG Warehouse is designed specifically for this role, enabling long term storage of millions of annotated ECGs within its highly scalable framework. Such properly maintained and archived datasets will accelerate the investigation of improved biomarkers leading cardiac safety beyond the QT interval.