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In 1985 Biomedical Systems conducted our first Digital ECG study in a clinical trial for the pharmaceutical industry. Since then, our team of dedicated professionals has continually set the industry standard by providing Sponsors with innovative solutions to their trial needs. We continually improve on the accuracy of the data acquired and analyzed, seek quicker timeframes to database lock, and explore new and more cost-effective ways to conduct ECG trials. Biomedical Systems has invested in new technology to exceed the expectations of the pharmaceutical industry. This combination has kept Biomedical Systems the global leader in ECG clinical trial work.
Biomedical Systems has been working in a digital ECG environment since the very beginning. To date, Biomedical Systems has participated in over 2,000 digital ECG trials. With our centralized digital approach Sponsors receive:
- Web based Sponsor access to data and reports
- 21 CFR Part 11 compliance regarding electronic documents and electronic audit trails
- Cardiologists’ annotations captured electronically on all ECG interval onsets and offsets
- Data verified and cleaned prior to electronic submission to Sponsors according protocol
- Protocol specific metrics available to Sponsors
- Complete 10-second electronic digital raw ECG waveforms with electronic storage
- Certified to submit data into the FDA ECG warehouse
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Biomedical Systems has completed its second year of FDA ECG Warehouse certification. We have successfully submitted data uploads for three different supported formats. | The E-Scribe ECG Warehouse, developed in collaboration with the FDA, provides tools for annotated ECG review, scoring and warehousing. Annotated ECG datasets supporting new drug applications to 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.
For more information on Biomedical Systems Centralized ECG Sevices, please click here.
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I-Port is the revolutionary web portal introduced by Biomedical Systems that allows Sponsors to access their study ECG data and metrics in real-time, any time and anywhere web access is available.
Using cutting edge web based technology, this system was developed in-house as an efficient tool for Sponsors and Project Managers to access real time ECG data that includes:
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