ECG Core Lab

A highly automated ECG core laboratory, enabling faster access to quality data

Global Expertise With Leading Edge Methodology and Technology

We are the world’s largest early phase CRO with an integrated ECG core lab. Our team of cardiologists, clinical pharmacologists, biometrics specialists, statisticians and data management experts actively collaborate with you to provide innovative solutions for your needs. We have 20+ years of experience drafting hundreds of complex study designs involving a multitude of compounds, while conforming to the latest regulatory requirements. We've also produced a number of peer-reviewed publications as thought leaders in the field of drug development, and have successfully executed clinical trials in support of multiple approved FDA compounds.

Our ECG core lab uses industry-leading software and methodology to provide you with quality data in a fast, cost-efficient manner. We also offer a broad suite of diagnostic and imaging capabilities to profile QT and off-target cardiovascular liability, as well as, onsite multichannel telemetry monitoring conducted by certified nurses to aid in real-time assessment of heart rate and rhythm.

Clinic Integration

The ECG core lab is integrated with the clinic, which offers many benefits, such as: optimal training and oversight of staff thereby ensuring SOP compliance to reduce queries and poor quality or missing data; immediate intervention to troubleshoot technical issues; onsite data collection to facilitate rapid turnaround of information and real-time quality assessment; and quick downloads of 12-lead ECG recordings, making it possible to rapidly evaluate adverse events and subject safety concerns.

Pharma QT Expert Readers

Our team consists of board-certified cardiologists who are pharma QT experts with over 25 years of combined experience and over 2 million ECG readings conducted. Our highly automated process includes assigning just one cardiologist per study, which promotes consistency in diagnosis and interval measurement. Our intrareader and interreader QT variability exceeds the industry standard for crossover and parallel design trials. We are available 24/7 to consult with you and our principal investigators about any ECG/arrhythmia concerns or cardiovascular adverse events.

One Device for Cardiodynamic and Safety ECG acquisition

We use a single high-fidelity Holter device to collect continuous digital 12-lead ECG recordings for both safety and cardiodynamic analysis thereby eliminating the need for multiple devices. LCD screens optimize data quality by allowing visual inspection of all 12 leads before each collection time point. Digital recordings enable prompt onsite or remote review of safety ECGs to address potential adverse events or subject safety concerns.

Quality Results

Our ECG Core lab FDA metrics for QT analysis and acquisition quality averages 99.8% when compared to other ECGs in the FDA ECG warehouse. By using a representative median beat at 1ms resolution, we’re able to provide more precise and accurate interval measurements for optimal QT liability assessment. Assay sensitivity has also been confirmed in 100% of our studies with Moxifloxacin, and we’ve never had FDA or client audit concerns with our HL7 FDA submissions.

Efficiency

Our hybrid ECG Core Laboratory offers you a high-quality, cost-effective solution, with just one contract for both clinical conduct and core laboratory services. By streamlining our processes and procedures, we facilitate faster generation of results and shorten your drug development timelines.