ECG Core Lab

CPC is committed to cardiovascular safety in new drug development by providing timely, rigorous, high-quality interpretation and analysis of study-related ECG variables.  Our capabilities as an ECG Core Lab include:

• Utilization of state-of-the-art Mortara E-Scribe, H-Scribe and GE Muse systems to support ICH-E14 concordant analysis of ECG data
• Timely analysis and interpretation of digital 10-second 12-lead ECG strips
• Expert study reports for thorough QT and safety trials
• 21 CFR Part 11 compliant data acquisition and processing
• Quarterly or study-specific inter- and intra-reader variability (IIRV) reports
• Rigorous QA/QC processes
• Continuous interpreting cardiologist training program
• Full service biostatistical and data management capabilities facilitating integrated and timely analysis of clinical, pharmacokinetic, and ECG data
• Electronic submission of XML files to the FDA warehouse

Through an established partnership with ICON Development Solutions (Healthcare Discoveries), a state-of-the-art Phase I unit in San Antonio Texas, CPC provides seamless implementation of ECG studies from bedside to expert report and FDA ECG warehouse submission. This partnership features:

• Instantaneous automated transmission of digital ECG data via an established, secure and dedicated connection
• Jointly developed SOPs and cross-institutional team meetings ensure quality ECG data acquisition, processing, and enhanced workflow

For more information Contact Us