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12-Lead Electrocardiogram (ECG) Services |
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Digital ECG
12-Lead Electrocardiogram (ECG) Services
CoreLab Partners is internationally recognized as a leading provider of ECG services with more than 25 years of experience in the collection, management, and analysis of ECGs. With experience working alongside the ICH and FDA in the development of regulatory and industry guidelines, CoreLab Partners is best positioned to aid you in the design and conduct of your next cardiac safety and efficacy study.
CoreLab Partners’ staff is composed of board-certified cardiologists, project managers, data managers, and biostatisticians with extensive experience in the collection, review, and reporting of ECG data.
CoreLab Partners offers a full range of ECG and Thorough QT (TQT) services across all study phases and include:
- Standardized digital 12-lead ECG and equipment
- 12-lead digital Holter
- 12-lead Holter ECG time point extraction
- 12-lead ECG hardcopy digitization and overread
- Direct ECG upload and transfer from Phase I unit platforms
- State-of-the-art cardiac safety analysis methodologies and advanced technologies
CoreLab Partners 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, CoreLab Partners also offers:
- Expert support with program and protocol design
- Expert cardiac safety analysis and reporting
- Internet access to ECG data
- Turnkey, digital ECG collection technologies
World Leading Platform
CoreLab Partners exclusively employs WebHeart®, our industry leading web-based system for the management, processing, and analysis of cardiovascular safety and efficacy data.
ECG Data Submission
CoreLab Partners can provide data in a variety of formats required for regulatory submission. Mortara® certified, we have successfully submitted annotated XML files for submission to the FDA ECG Warehouse on multiple occasions.
CoreLab Partners 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.
A Higher Level of Service
Your team at CoreLab Partners is committed to providing the highest level of service:
- High-quality study with the flexibility you need
- An efficient team focused on your needs and goals
- Secure, web-based access to ECG study data through proprietary WebHeart management platform
Datasheet
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