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12-Lead Electrocardiogram (ECG) Services |
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Digital ECG
12-Lead Electrocardiogram (ECG) Services
CoreLab Partners is 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.
Our staff is composed of board-certified cardiologists, certified cardiographic physician/technicians (CCT), 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 technology and evaluation methodologies as well as comprehensive services across all study phases, including program design consultancy, TQT, and intensive QT studies. Our technology and methodologies include:
- Standardized digital 12-lead ECG and equipment
- 12-lead digital Holter
- 12-lead digital 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
- ECG interval measurement options from fully manual digital on screen to semi-automated process
- Integration of AMPS BRAVO ECG algorithm within WebHeart
- Semi-automated ECG process solutions
Expert Consultancy Service
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 consultancy with program and protocol design
- Expert cardiac safety analysis, and reporting
- Interim cohort reporting for early phase clinical trials
World Leading Platform
CoreLab Partners employs exclusively WebHeart®,, our industry leading web-based system for the management, processing, analysis, and reporting 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:
- Expert advice on regulatory & clinical strategy within framework of development program and specific compound
- High-quality study with the flexibility and transparency you need
- An efficient team focused on your needs and goals
- Secure, web-based access to real-time ECG study data
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