ECG Core Lab

Improving ECG data collection and analysis using high-tech equipment

Our core lab is situated at our clinical unit at London Bridge, offering a focused work environment for TQT trials with no additional costs, thereby delivering value for money to pharmaceutical sponsors.

We use FDA compliant MAC 2000 resting ECGs and Digital12-Lead Holter devices for collection, transmission and processing of digital ECG and Holter recordings for TQT studies. Each bedside has a GE MAC 2000, 12-lead ECG machine connected to the MUSE® Server allowing for storage of thousands of digital ECG’s. These digitised ECG's are available to our cardiological sciences team as required for subsequent digitised reading, analysis and reporting. The system is FDA 21 CFR Part 11 compliant with secure authorized user access and password protection to allow access to users for their required access levels only. A detailed audit trail is available and includes the username, date and time of access of any individual using the system and what addition or change they made to the database.

The digital 12-Lead ECG machines used for our studies are configured to ensure every ECG data file contains the exact and correct information in FDA compliant format (HL7) as per ICH E14. The configuration of each machine used in our TQT studies undergoes a vigorous validation process, including acquisition and transfer of test ECGs from the machine’s simulator. The standard configuration and validation process is fully documented and available to clients upon request.