With unrivaled expertise and experiences in end-to-end drug development programs, CD BioSciences provides integrated solutions for the entire program from bioanalytical lab testing, first-in-human (FIH), proof of concept (POC), clinical trial development, to data management. You can partner with us for the entire program or just one module. We guarantee you complete flexibility.
FIH is a critical milestone in the entire drug development program. With extensive experience in the design and conduction of FIH studies, our experts are dedicated to closely working with you to meet your objectives and milestones for small molecule or biologics drugs. We provide FIH studies to facilitate your drug development including study design, study conduction, analyzing and reporting. Moreover, we provide the regulatory support in U.S. and several other countries. We can translate your preclinical data into clinical trial design and conduction. The most important thing is that we consider the participant safety as the priority with stringent risk mitigation plans, which is customized and based on the specific drug target and available preclinical data.
To better serve your entire FIH study, our experts have rich expertise across different disciplines. The expert teams include clinical pharmacologists, safety physicians, formulation scientists, clinical development scientists, clinical operation specialists, toxicologists, regulatory affair specialists, and etc. Our clinical pharmacologists are experienced in single and multiple dose studies for various effects analysis, such as age, gender, food and others. Our toxicologists are dedicated to providing support for starting dose calculation. In addition, they closely work with our clinicians in determining best clinical study monitoring approaches to observe the effects that are based on the preclinical data.
Safety is Our Priority
Our clinical team is committed to ensuring the participants safety before initiating each FIH study. We provide stringent participant oversight to ensure the safe conduction of various ascending dose studies.
Empowered by our extensive 10+ years of experience conducting early clinical trials with state-of-the-art facilities, our clinical team is dedicated to meeting your specific requirements of early clinical trials for regulatory submission purpose.
We provide FIH studies across a wide range of therapeutic areas for different drug types including small molecules, cellular therapies, therapeutic antibodies, and etc. If you have FIH study requirements for your drug development program, please don’t hesitate to reach out to our clinical team for assistance.
With extensive experience in recruiting healthy participants, patients or special populations, CD BioSciences is able to quickly fill the cohorts and conduct FIH studies for your specific requirements. We are dedicated to being a full-service CRO focusing on the early clinical trial development programs. Please contact us to learn how we can help with your upcoming FIH study.
1. Shen, Jie, et al. "Design and Conduct Considerations for First-in-Human Trials." Clinical and Translational Science 12.1 (2019): 6-19.