How AXIS Clinicals delivered high-quality DDI data through precise execution and rapid recruitment across multiple studies
Drug–drug interaction studies are among the most demanding components of early-phase clinical development, requiring tight protocol control, balanced enrollment, and uninterrupted operational execution. For one sponsor developing a tricyclic small molecule for Hepatitis D, timely completion of multiple DDI trials was critical to maintaining development momentum and meeting regulatory expectations.
AXIS Clinicals successfully executed six single-site, open-label DDI studies, enrolling more than 170 participants and completing all trials on schedule. Each study required multiple in-house stays, steady-state dosing, and continuous safety monitoring, all delivered without delays or data quality issues.
This case study explores how AXIS combined operational agility, recruitment excellence, and scientific rigor to manage complex study designs, enroll specialized populations including post-menopausal women, and consistently deliver submission-ready data aligned with FDA and EMA expectations.
See how disciplined project management and flexible recruitment strategies supported reliable outcomes across overlapping DDI programs.
Read the full case study
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About AXIS Clinicals
AXIS Clinicals is the leading clinical and bioanalytical pharmacology research organization conducting studies in healthy volunteers and targeted populations.
AXIS Clinicals Contact
John Pottier | Senior Vice President, Business Development
+1 (913) 314-6755
j.pottier@axisclinicals.com
axisclinicalsusa.com