Clinical Services: ECG Services
12-Lead Modem Based Digital ECG
Digital 12-lead ECG devices allow immediate transmission of ECG data from the site and full digital processing with FDA compliant XML/HL-7 format output. The manufacturer's trained technicians provide on-site installation, training and validation certification.
12-Lead Holter/3-Lead Holter
12- and 3-lead Holter offer ST segment, RR variability, arrhythmia analysis and event recording, and 12-lead Holter allows individual 12-lead ECGs to be captured at multiple time points. We perform additional analysis of QT data using automated Holter-Bin methodologies.
ECG Project Management
Quintiles project managers coordinate every step of the product development process, including ECG data collection, monitoring and reporting. They are also responsible for maintaining effective and efficient communication with sponsors and all sites, providing monthly metric reports and ensuring a high level of customer service and satisfaction throughout the process. At study inception we appoint a dedicated project manager and a named backup to be your single point of contact throughout the project. Your project manager will arrange his schedule to coincide with yours, regardless of where the clinical trial is being conducted, and will always be available for meetings or conferences.
Digitalization of ECGs Originally Recorded on Paper
New cardiac safety guidelines require ECGs to be read manually using a digitized process/outcome. Even so, it is estimated that 95% of all ECG data is originally recorded only on paper.
We were among the first to have developed fast, cost effective procedures for converting traditional paper ECGs into a regulatory-compliant XML/HL-7 digital format. We then perform all data management, analysis and reporting in digital form. Digitalization also facilitates the analysis or reanalysis of ECG data retrospectively.
Turnkey Digital ECG Collection Technologies
The Quintiles ECG team offers you a choice of world class regulatory compliant digital ECG equipment and ensures that all sites receive training prior to study start. We also provide free access to a 24/7/365 Help Desk supporting 36 languages to solve technology-related problems on the spot.
The Quintiles ECG Web Portal
All project and site metrics are available to all parties through a dedicated, secure Web portal. We post data and graphical reports immediately after each ECG has been analyzed, reviewed by a board certified cardiologist and approved for reporting. Each actual tracing with annotations is available on the site in near real time.
Expert QT Reporting
Our cardiologists and statisticians understand the global regulatory landscape of QT prolongation, as well as all pertinent cardiac electrical conduction disturbances and abnormalities, from all perspectives: clinical research, regulatory, pharmacovigilance and post-marketing surveillance.
Because cardiac safety is the primary goal, we have incorporated a standard proactive data table and trend analysis procedure in which a cardiologist reviews data tables and listings during the course of the study. This review can capture data and/or patient-specific anomalies for rapid action and investigation.
ECG Data Management
At the start of each study, the Quintiles ECG team appoints a data manager and a named backup for each project, as well as dedicated data management and analysis specialists who will stay with you until you receive the final data export – which will be within two weeks of the last patient out. We use the CLINTRIAL 4.3 data management platform, and provide rapid access to annotated ECG data in CDISC approved formats (XML, SAS, ASCII) as well as regular data transfers.
Site Support
As part of our normal startup process, we provide a broad choice of turnkey digital ECG collection technologies as well as efficient, cost effective options for the digitalization of ECGs originally recorded on paper. We arrange full, certified on-site training by the equipment manufacturers, and ensure connectivity for ECG transmission. Even with this effort, sites may have questions or issues that need immediate resolution. Part of our site support process is the use of a 24/7/365 help line which supports 36 languages. Staff in our multilingual call center can either solve problems directly or refer them for quick answers. In addition, a FAQ section on the Quintiles ECG Web Portal provides answers to common questions.
