With your investigational new drug (IND) or investigational medicinal product dossier (IMPD) authorization in hand, the first-in-human or phase I study is the launching point of your clinical development.
To ensure a smoothly conducted study, our bioanalysis, immunology, and safety laboratories are conveniently gathered under one roof with our clinic unit. For your dose escalation studies, we are able to enroll healthy volunteers, special populations, and patients, and we also have strong experience in respiratory clinical studies.
For each study, data management, statistics, and monitoring are managed by experienced statisticians and statistical programmers working seamlessly with our data management team.
With our successful experience in various therapeutic areas, you can entrust our corporate project management experts with your most challenging requests, while our regulatory affairs team can support you with scientific writing of IMPDs, and a clinical development plan (CDP) tailored to your product.