First-In-Human (FIH) Studies
Our company excels in conducting First-In-Human (FIH) studies across various therapeutic areas. Our experienced medical team, including Principal Investigators (PIs) and Physician Assistants (PAs), ensures the safe and efficient execution of FIH studies, paving the way for crucial early insights into investigational products' safety and efficacy profiles.
14C-hADME Studies
Our expertise extends to conducting 14C-hADME (Absorption, Distribution, Metabolism, and Excretion) studies, utilizing advanced radiolabeling chemistry and state-of-the-art analytical techniques. These studies provide in-depth insights into drug metabolism, pharmacokinetics, and bioavailability, aiding in optimizing drug development pathways and dosage regimens.
Thorough QT (TQT) Studies for Cardiac Safety
Our company specializes in designing and executing Thorough QT (TQT) studies, focusing on assessing cardiac safety parameters accurately. Our precise ECG data collection and expert interpretation ensure thorough evaluations of investigational products' effects on cardiac repolarization, crucial for regulatory compliance and patient safety.
Comprehensive Study Management
Our company offers full-service study management, encompassing regulatory affairs, project management, medical writing, clinical monitoring, pharmacovigilance, and quantitative pharmacology. Our integrated approach streamlines processes, enhances data quality, and ensures compliance with regulatory guidelines throughout the study lifecycle.
