Celerion’s cardiac safety expertise combines large-scale operational capacity with specialized ECG monitoring capabilities to support comprehensive QT assessment studies.
Thorough QT (TQT) Studies
Key Capabilities
IN-HOUSE ECG CORE LAB with board-certified cardiologists providing expert ECG interpretation and dedicated equipment streamlined with clinical operations
EXPERT ECG TECHNICIANS experienced in placement of ECG leads and Holter monitors
PLACEBO AND POSITIVE CONTROL PREPARATION with a 100% success rate in positive control validation, ensuring proper study blinding and reliable cardiac safety endpoints
ROBUST PARTICIPANT RECRUITMENT capable of enrolling large TQT study cohorts
LARGE CLINIC CAPACITY providing flexibility for scheduling large volunteer cohorts
PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types
PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in TQT study design and cardiac safety endpoint optimization
BIOANALYTICAL SERVICES with validated assays for parent compound and metabolite analysis, featuring single vendor responsibility and direct clinic-lab communication supporting comprehensive cardiac safety evaluation
LICENSED PHARMACISTS for investigational product preparation and distribution
FULL-TIME INVESTIGATORS AND ACLS-CERTIFIED NURSING STAFF providing expert oversight, training, 24/7 medical coverage, and cardiac monitoring expertise.
STANDARDIZED MEAL PREPARATION by registered dietitians in an on-site kitchen, ensuring consistency with food intake requirements
ON-SITE CAP/CLIA-CERTIFIED LABORATORY with 24/7 coverage for rapid laboratory value turnaround
COMPREHENSIVE PAPERLESS ECOSYSTEM featuring ClinQuick™ EDC, Veeva Vault integration (eICF, eISF, eCOA, eTMF), and proprietary Celexus platform delivering 21 CFR Part 11 validated systems with real-time data visualization, automated quality checks, and seamless sponsor portal access for immediate study oversight
AAHRPP-ACCREDITED FACILITIES ensuring participant safety
