First-in-Man Clinical Trials

Patient care. Sponsor support.

First-in-man clinical trials require detailed preparation and care. We recognize our ethical and safety responsibilities to study participants and understand the critical role these tests play in moving a compound forward. Our diverse experience, attention to detail, and access to special populations helps ensure a smooth transition into ascending dose studies.

When beginning a study, we can rapidly recruit study participants using our in house database and existing relationships with leading hospitals. A dedicated project team, which includes project management, regulatory, quality and scientific specialists, is assigned to each study in order to develop and execute a program that meets all your requirements. The study is then deployed in one of our modern clinical facilities in Miami or Quebec City.

Drug concentrations and biomarkers of interest can be measured on-the-spot in our bioanalytical laboratories and integrated into study reports. We have worked extensively with both small molecules and biological compounds, including monoclonal antibodies (mAbs), and have the capability to manage all aspects of the study process. We are also experienced with combination study designs (Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) combined in a single protocol) as a means to reach proof-of-concept faster, safer and more economically.

Phase I-IIa Brochure

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