Our specialized food effect capabilities ensure precise control of nutritional variables critical for accurate bioavailability assessments under fed and fasted conditions.
Food Effect Studies
Key Capabilities
SPECIALIZED MEAL PREPARATION by registered dietitians in an on-site kitchen, providing specified, consistent diets for fed/fasted studies
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 incorporating food effect objectives into SAD/MAD protocols
LICENSED PHARMACISTS for investigational product preparation and timing coordination
BIOANALYTICAL SERVICES providing validated assays for parent compound analysis with end-to-end sample integrity oversight and streamlined operations supporting precise food effect assessments
EXPERT SAMPLE HANDLING ensures sample integrity throughout collection and processing
ON-SITE CAP-CERTIFIED LABORATORY for rapid turnaround of laboratory values
FULL-TIME INVESTIGATORS providing oversight and training on food effect protocols
FULL-TIME INVESTIGATORS AND ACLS-CERTIFIED NURSING STAFF providing 24/7 medical coverage throughout the study conduct
ROBUST PARTICIPANT RECRUITMENT from a well-maintained 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
AAHRPP-ACCREDITED FACILITIES meeting regulatory standards