First In Human (FIH)
Since 2003, we have been designing, conducting, analyzing, and reporting on FIH studies for small molecules and biologics, and we offer the opportunity to begin the regulatory process in either the U.S. or Canada. Our clinical pharmacologists are proficient at designing single and multiple ascending dose studies, as well as testing for various effects, such as age, gender, and food. We routinely include assessments of biomarkers or symptom assessments to establish proof of concept. Our toxicologists provide support in calculating starting doses, and work with our clinicians in determining best clinical study monitoring practices for effects observed during preclinical trials.
Our clinics have purpose-built units that offer the stringent patient oversight required to safely perform ascending dose studies. Before starting each study, our clinical teams perform a risk assessment to ensure we are appropriately staffed and resourced to ensure participant safety.
We have the recruiting experience and capacity to quickly fill cohorts that are dosed weekly, and can add patient cohorts or conduct entire studies in patients, as needed.
Consult our FIH Fact Sheet
- Healthy Participants
- Special Populations (age, BMI, or gender specific)
- Patient Populations
- 200+ COMPLETED FIH STUDIES SINCE 2010
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.