Early-phase studies begin with healthy volunteers, but regulatory approval requires data from patients with impaired organ function and other at-risk groups. Both EMA and FDA expect Sponsors to evaluate how investigational drugs behave in renal and hepatic impairment cohorts before market authorization.

At Astrum, our 60-bed hospital-based Phase I unit in Porto and our 11-hospital hospital resercah network give Sponsors direct access to these critical patient populations. This enables us to generate regulatory-ready data packages while also supporting translational studies that accelerate proof-of-concept.