Celerion’s first-in-human and dose escalation expertise provides the safety infrastructure and rapid decision-making capabilities essential for early-phase development programs.
Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)
Key Capabilities
PROTOCOL DEVELOPMENT SUPPORT with writers and scientists experienced in dose escalation design and first-in-human study protocols
ESTABLISHED DOSE ESCALATION PROTOCOLS with results available within 24 hours for rapid go/no-go decisions
FULL-TIME INVESTIGATORS AND ACLS-CERTIFIED NURSING STAFF providing 24/7 medical coverage with extensive adverse event management experience
INTENSIVE CARE UNIT equipped with hospital beds for invasive and controlled procedures
ON-SITE COMPOUNDING PHARMACY with licensed pharmacists for complex formulation needs
BIOANALYTICAL SERVICES for expedited PK analysis and rapid turnaround between dosing cohorts with streamlined single vendor operations and direct clinic-lab integration supporting real-time decision making
REAL-TIME TRENDING SOFTWARE built into Celexus for monitoring laboratory, AE, vital signs, and ECG data
SPECIALIZED SAMPLE COLLECTION CAPABILITIES including biopsies, cerebrospinal fluid (CSF), and other biological samples
TELEMETRY MONITORING for continuous cardiac assessment
IN-HOUSE ECG CORE LAB with board-certified cardiologists and dedicated equipment streamlined with clinical sites
ESTABLISHED IRB RELATIONSHIPS for rapid amendment processing
NETWORK OF LOCAL MEDICAL SPECIALISTS including optometry, anesthesiology, neurology, and dermatology
IMAGING SERVICES supporting protocols requiring diagnostic imaging and interpretation
FLEXIBLE SCHEDULING with timeline modification capabilities
FULL-TIME INVESTIGATORS providing expert oversight and staff training
ON-SITE CAP-CERTIFIED LABORATORY for stat turnaround of critical laboratory values
AAHRPP-ACCREDITED FACILITIES ensuring participant safety and regulatory compliance
PROVEN REGULATORY EXCELLENCE with positive FDA inspection history, demonstrating consistent compliance, quality standards, and inspection readiness across all study types
