Celerion announces highly automated ECG Analysis enabling data delivery within 37 days from first patient dosed
Clients benefit from faster access to higher quality data and cost savings in their drug development programs.
(Lincoln, NE; Jun 20, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, announces the successful completion of a 133 participant parallel design Thorough QT (TQT) study using the innovative Celerion Hybrid Phase I/ ECG Core Lab. The efficiencies developed in both clinical conduct and ECG analysis enabled Celerion to quickly collect and analyze over 9,000 ECG recordings, delivering the final dataset containing all data for the study to the sponsor company within 37 days from first patient dosed.
“This study continues to demonstrate Celerion’s commitment to implement innovative technologies that enable fast access to high quality data and ultimately save costs for clients,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “The Hybrid Phase I/ ECG Core Lab, when used for the execution of TQT studies and ECG assessment in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, enables our clients to deliver on their goal of getting products to market faster.”
The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion’s global Phase I clinical network that minimizes cardiologist review time and expense. This novel approach was built upon the knowledge gained from conducting more than 100 studies with intensive ECG monitoring including 36 TQT studies and fully integrates both the core lab and clinic functions. Extensive experience in early cardiac safety services allowed Celerion to carefully define where efficiencies could be realized when developing the Hybrid Phase I/ ECG Core Lab. Integration of the core lab and clinic minimizes the inefficiencies associated with separate management of the two functions.
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.