Highly Automated ECG Core Lab enables faster access to high-quality data at a lower cost.
- ECG Core lab located in the clinic enables short start-up times and the flexibility needed during First-in-Human studies
- Highly automated approach using cutting-edge technology, enables automated measurement of ECG recordings, and minimizes the number of ECG recordings that require cardiologist review
- Streamlined integrated processes ensure data integrity from data collection to data analysis
- Broad range of TQT studies performed involving 20 to 250 subjects, demonstrating ability to efficiently conduct studies while maintaining strict data quality and patient safety standards
- ECG Core lab senior staff has more than 10 years of experience working with regulatory authorities and assisting with study design, data analysis, and expert report writing
- Technical and scientific expertise of core lab available on site during Holter monitor data collection
- US Board certified cardiologists with over 25 years of industry experience reading Holter and ECG data for the pharmaceutical industry with intra- and inter-reader variability results that exceed industry standards
- ECG Core lab data delivered with clinic data at the time of database lock or earlier depending on client needs
- Co-located ECG Core lab and clinical facility enables direct visibility and oversight of clinical conduct by the ECG Core lab staff
- Significant cost and time savings for the conduct of TQT studies and ECG assessment in Single Ascending Dose and Multi-Ascending Dose programs, by minimizing cardiologist review, integrating functions and decreasing overhead
- Recently completed a 135 subject parallel QT study from first patient enrolled to database lock in just 37 days, and at approximately half the cost of a traditional ECG core lab
Data analyzed through the Highly Automated ECG Core Lab has been successfully submitted to the FDA. Learn more about Celerion’s comprehensive services in Cardiovascular Safety Services.