Celerion’s pharmacodynamic capabilities support complex biomarker and mechanism-of-action studies with specialized procedures and comprehensive safety monitoring.
Pharmacodynamic (PD) Studies
Key Capabilities
PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in PD study design and biomarker protocol development
SPECIALIZED SAMPLE COLLECTION including biopsies, cerebrospinal fluid (CSF), and other biological samples
NETWORK OF MEDICAL SPECIALISTS including optometry, anesthesiology, neurology, and dermatology
IMAGING SERVICES supporting protocols requiring diagnostic imaging and interpretation
IN-HOUSE ECG CORE LAB with board-certified cardiologists and dedicated equipment streamlined with clinical sites
COMPREHENSIVE TRAINING PROGRAMS for development and execution of specialized procedures
24-HOUR MEDICAL COVERAGE with extensive adverse event management experience
LARGE SPECIALIZED UNITS for housing complex equipment and procedures
FLEXIBLE SCHEDULING with timeline modification capabilities
ON-SITE CAP/CLIA-CERTIFIED LABORATORY with 24/7 coverage for rapid laboratory value turnaround
EXPERT SAMPLE HANDLING ensuring integrity of specialized biological samples
PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types
FULL-TIME INVESTIGATORS providing expert oversight and training
CUSTOMIZED MEAL PREPARATION by registered dietitians in an on-site kitchen supporting specific dietary requirements
ROBUST PARTICIPANT RECRUITMENT from extensive volunteer database
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
BIOANALYTICAL SERVICES providing validated biomarker assays and specialized analyte analysis with direct clinic-lab integration, single vendor responsibility, and comprehensive sample integrity oversight supporting pharmacodynamic endpoints
AAHRPP-accredited facilities ensuring the highest safety standards
