Healthy Normal Volunteers

Healthy Normal Volunteers (HNV) play a critical role in drug development. They are the key to gaining safety and efficacy data in clinical studies, but not all HNV trials are created equal.

Our team has over 25 years of experience conducting traditional and atypical HNV trials, such as:

    • First-in-Human
    • SAD/MAD
    • Adaptive Design
    • Early Cardiac Safety Assessment (as an alternative to TQT)
    • Drug-Drug Interaction
    • Bioavailability/Bioequivalence

    • Bioavailability/Bioequivalence
    • Food Effect
    • Pharmacokinetics/Pharmacodynamics
    • Driving Simulation
    • Cognitive Testing
    • Biologics/Biosimilars

Feasibility Review

Our Principal Investigators and study team conduct a full feasibility assessment, which includes a full recruitment estimate, staff availability assessment, evaluation of possible competing studies, protocol review, and timeline appraisal. We identify any issues that may hinder the progress of the study and create solutions to ensure success.

Linking Preclinical to Clinical

Through a strategic alliance, we are able to offer sponsors a customized pathway to drug development programs, from lead candidate selection through to early stage clinical trials. Pharma companies and biotechs are able to work with a single, integrated partner to develop molecules through to human proof of concept. Minimizing hand-offs through the process results in faster timelines and reduced costs.

Recruitment and Retention

Our proactive and study-focused recruitment strategy that combines both our large database with multiple media channels ensures recruitment milestones are met, even for studies with complex inclusion/exclusion criteria. Our facilities are designed for optimum recruitment and retention of healthy volunteers for long and short-term confinement periods.

Customized Study Designs

With the increased pressure for pharmaceutical and biotech companies to get new drugs to market as quickly as possible, it is imperative to implement processes to shorten timelines and reduce study costs while maintaining high standards of quality and safety.

Our team of experienced clinicians and scientists integrates innovation, expertise, and the latest scientific and regulatory development requirements into each clinical trial. This team is composed of seasoned clinical research professionals with a wide spectrum of knowledge and backgrounds who have the expertise to design and execute traditional early phase trials in healthy volunteers as well as complex, adaptive designs. With their broad range of experience, the team can serve as a reliable reference for scientific and regulatory issues for the wide spectrum of HNV studies

 

For more information about our capabilities and experience, or to discuss your early development program, contact our team today.