Digital ECG Assessments
Bioclinica offers a full range of digital ECG technology and comprehensive ECG services across all clinical study phases. Our ECG interval evaluation methodologies include semi-automated and fully automated capabilities, as well as fully manual on-screen assessment. Bioclinica understands the impact of ECG and cardiovascular data on drug development and can provide you with cardiac safety services from protocol design to reporting. We have experience in interacting with regulatory authorities and assisting in compliance with FDA and ICH initiatives within the global research arena. We are Mortara certified for ECG data submission to the FDA ECG warehouse and can provide ECG data in a variety of formats to meet sponsor format specifications.
ECG Assessment Methodology and Technology
The decision on ECG interval measurement is driven by sponsor scientific working groups, consideration for the study population, phase of the study (I-IV) and existing cardiac safety QT information on the study compound.
- Standardized digital 12-lead ECG and equipment
- 12-lead digital Holter with ECG extraction.
- Continuous ECG collection (Patch technology)
- 12-lead ECG hardcopy digitization and overread
- On-screen manual, semi-automated and automated ECG solutions
- Industry recognized expertise of the AMPS platform within the WebHeart™ cardiac safety platform
- BRAVO and FATQT ECG analysis tools
- Direct ECG upload and transfer from Phase I unit platforms
Bioclinica can configure the WebHeart™ platform to pre-define the specific lead selection which will be used for both the interval measurement and diagnostic interpretation by dedicated board certified cardiologists. In addition, Bioclinica can support the use of the global median beat for ECG evaluation. Our standard process is for 100% overread of study ECGs by a dedicated board certified cardiologist.
Continuous Digital Holter and ECG Extraction
The use of 12-lead, digital Holter recorders can substantially reduce the logistical complexity of acquiring the large number of electrocardiograms required for TQT, Intensive TQT and MAD/SAD studies. Bioclinica offers two options for continuous Holter recording technology (24+ hours and 12-lead) captured on industry-standard sampling frequency flashcards and SD cards. One of the 12-lead digital Holter devices that Bioclinica has incorporated into its service line provides for both standard 12-lead ECG capture as well as continuous 12-lead digital Holter monitoring.
When it comes to digital Holter, Bioclinica offers:
- Analysis of Holter data for Arrhythmia, Heart Rate variability, and Heart Rate Turbulence (HRV/HRT) by certified cardiographic technicians.
- Real time Holter ECG extraction and transmission at the Phase I unit via our proprietary WebHeart™ platform and Web upload of Holter data from clinical sites to Bioclinica.
- Advanced heart rate monitoring solution for clinic-based heart rate monitoring that does not require a formal telemetry solution.
Bioclinica 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, Bioclinica is best positioned to help you in the design and conduct of your next cardiac safety study. Our staff is composed of board-certified cardiologists, certified cardiographic physicians/technicians (CCT), project managers, data managers, and biostatisticians with extensive experience in the collection, review and reporting of ECG data.
Centralized ECG Services
Bioclinica has the scientific expertise, experience and regulatory insight to support your cardiovascular safety study across all clinical trial phases, from protocol design to regulatory submission.