E-Scribe ECG Warehouse: A public/private collaboration
The E-Scribe ECG Warehouse, developed in collaboration with the FDA, provides tools for annotated ECG review, measurement, and warehousing. Annotated ECG datasets, supporting new drug applications to the FDA, will be uploaded by sponsors and central laboratories into the E-Scribe ECG Warehouse free of charge to facilitate regulatory review using the toolset provided by Mortara.
Sponsors wishing to utilize this same toolset, either prior to submission, during an active study, or as a long term archiving and study-metrics tracking solution, can do so by subscribing to the Mortara E-Scribe ECG Warehouse. The E-Scribe ECG Warehouse can be subscribed to on a study-by-study or program basis and provides a host of useful tools for validation, review, and generation of quantitative study metrics.
Only FDA reviewers are allowed access to aECG data provided in support of drug applications. Organizations providing aECG data to the FDA can make arrangements with Mortara to validate and view their own data prior, during, and/or after FDA review. Organizations can also make arrangements to validate, warehouse, and analyze aECG data sets independent of FDA reviews.
In addition to data warehousing, sponsors can elect to use the E-Scribe ECG Warehouse tools for dataset import and format validation, web-based query, and review of ECG data and VERITAS™ algorithmic scoring for rank ordering ECG records of interest.
Mortara Certified Partner
As part of Mortara's on-going investment to support the digital ECG
initiative, the Mortara
Certified Partner program was created. This
program serves central laboratories and provides expert consultation
and validation of HL7-annotated ECG toolsets that generate records
to be uploaded to the E-Scribe ECG Warehouse. Working with Mortara
Certified Partners, sponsors can be assured of receiving annotated
ECG datasets that conform to the HL7 standard and that will be smoothly
imported into the E-Scribe ECG Warehouse.