12-Lead Electrocardiogram (ECG) Services
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Medifacts is internationally recognized as a leading provider of ECG services with more than 24 years of experience in the collection, management, and analysis of ECGs. Medifacts’ staff is composed of board-certified cardiologists, project managers, data managers and biostatisticians with extensive experience in the collection, review, and reporting ECG of data.
Medifacts offers a full range of ECG services that include:
- Standard digital, 10-second, 12-lead ECG
- Scanning and digitizing of hardcopy 10-second, 12-lead ECG
- Digital, 10-second, 12-lead ECGs extracted from digital Holter
Medifacts has the expertise and capacity to assist with other essential needs of trial conduct. In addition to the services typically provided with our centralized ECG offering, Medifacts can also provide:
- Expert feedback in program and protocol design
- Expert QT reporting
- Internet access to ECG data
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Turnkey digital ECG collection technologies
ECG Data Submission
Medifacts can provide data in a variety of formats required for regulatory submission. Medifacts has successfully submitted annotated XML files for submission to the FDA ECG E-Scribe ECG Warehouse on multiple occasions.
Medifacts understands the impact of ECG and cardiovascular data on drug development. We have experience in interacting with regulatory authorities and assisting in compliance with the suggestions outlined within the developing ECG Global Regulatory Imperative.