We are a boutique hybrid of academia, non-profit, pharmaceutical/ biomedical R&D, and sociobehavioral research/human-centered design. Our holistic approach to our work makes our products, technologies, and research solutions more innovative, cutting edge, and more likely to succeed.

We provide encompassing end-to-end expertise, from discovery to preclinical and early clinical testing, clinical trials (focusing on Safety, PK, PD, acceptability, and effectiveness), human-centered design and regulatory strategy, all the way through to implementation.

Translational & Preclinical Research

Mucosal susceptibility to HIV; novel mucosal safety endpoints; PK & efficacy models; novel adherence biomarkers

Product Development & Quality Assurance

Pharmaceutical & combination drug-device product development; technology transfer, set up, validation, and quality monitoring of cGMP manufacturing of clinical supplies

Adherence Support & Acceptability Testing

End user research to support product development, uptake, and adherence

IND Enabling

Testing plan design, implementation & oversight for pharmaceuticals, medical devices & combination drug-device products

Regulatory Submissions

Prepare documentation to support IND, IDE, NDA, and other regulatory requirements

Clinical Studies

Exploratory, Phase I, II, and III clinical trials and demonstration/implementation studies