The system uses Bluetooth-enabled Holter monitors to collect electrocardiograph (ECG) data. This is then automatically analysed, measured and assessed to determine if cardiologist review is required. Most ECGs will be automatically entered into a database with annotations.
Joy Olbertz, director, cardiac safety services at Celerion, told Outsourcing-Pharma that the project aims to benefit from new technology. MDS Pharma Services began the work on the system and now, after acquiring the assets, Celerion has implemented it across its Phase I sites.
The technology
The process starts with the Bluetooth-enabled Holter monitors. These can collect ECG data over 48 hours, giving them an advantage over other systems that are only capable of 24 hour monitoring.
Olbertz said that many clients want to take ECG data 24 hours after dosing. This leaves clinics using 24 hour Holter monitors with very little flexibility, said Olbertz, and consequently Celerion believes adopting the 48 hour model will improve its operations.
Data collected by the monitors is downloaded and Antares software automatically extracts periods of ECG recordings with minimal heart fluctuations and anomalous interfering signals.
Olbertz said that this data is fed through an ECG measurement algorithm. A second programme then analyses the information that the algorithm outputs and decides if cardiologist review is required.
The proportion of ECGs that are sent for further review is study dependent but is in the region of 10 to 20 per cent. Olbertz said the system uses cautious filtration parameters to ensure all ECGs that need reviewing are seen by a cardiologist. Also, all the ECGs are from healthy volunteers.
Clinic management
There are also benefits to having the clinic manage the ECG core lab. This gives the clinic direct oversight of the operation, provides a single point of contact for sponsors and improves communications. These factors reduce costs and minimise the likelihood of errors occurring.
Before implementing the system Celerion outsourced its ECG activities. All operations have now been brought in-house and this, coupled to the technological advances, gives Celerion a “huge advantage”, said Olbertz.
The system “just makes sense”, said Olbertz, and should allow clients to get through this stage of development “much cheaper and much faster”. Initial client feedback has been “very positive”, said Olbertz.
Celerion developed the system in collaboration with AMPS-LLC and Global Instrumentation. The process was “truly a partnership” to find the most efficient route to data output, Olbertz said. Celerion’s involvement in the development process means the system is tailored to its needs.