Celerion Launches New Hybrid ECG Core Lab for Phase I Clinics
Celerion
, a provider of early stage clinical research solutions, announces the launch of a new Hybrid Phase I/ ECG Core lab. The Hybrid Phase I/ ECG Core lab provides highly automated ECG analysis for Celerion’s global Phase I clinical network. Celerion’s approach employs new technology to perform automated measurement of ECG recordings, thereby minimizing cardiologist review and providing clients with faster access to data. The system also identifies the small number of ECG recordings that will still require cardiologist review. This reduction in cardiologist involvement, combined with smaller overhead compared to traditional ECG Core labs supporting global clinical trials, allows Celerion to offer cost and time savings to clients.
The Hybrid Phase I/ ECG Core lab was developed in collaboration with
AMPS-LLC
(Analyzing Medical Parameters for Solutions), and Global Instrumentation, LLC (GI). AMPS-LLC is a world leader in high quality ECG analysis software utilized by many ECG Core labs. Celerion is proud to host one of the first installations of AMPS’ FAT-QT and TrialPerfect software platforms, in addition to being one of the first contract research organization (CRO) to deploy the Global Instrumentation technology for Phase I/ ECG trials.
“By integrating the ECG functions within our clinic network, minimizing traditional ECG overhead and providing more automation, Celerion enables fast access to data and cost-effective solutions that deliver high-quality data for the execution of thorough QT studies and ECG assessment in SAD and MAD programs,” said Susan Thornton, CEO of Celerion.
According to Jim DeMaso, President of Global Instrumentation, “The GI M12R recorder and M12A Enterprise software provide Holter functions with full standard 12-lead ECG functionality in a centralized data management system designed for the requirements of clinical trials. We are pleased to be part of the Celerion/AMPS collaboration.”
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
