Astrum is proud that the Brazilian Health Regulatory Agency ANVISA recognises its Phase I unit, BlueClinical, as the only certified European Hospital-based Phase I unit. The unit is situated in Hospital da Prelada, Porto, Portugal, with up to 80 beds across 2 clinical wards. The hospital location provides all required emergency support and access to logistic services, such as the safety laboratory and imaging services, all in the same building.

This milestone is a testament to Astrum’s highly qualitative Phase I offering. With this accreditation, Astrum’s reach continues to expand, allowing the company to contribute to healthcare advancements on a broader geographic scale.

Astrum is a full-service CRO with its Portuguese operations and team focusing on early-stage clinical pharmacology and bioequivalence studies in healthy subjects and selected patient populations, as well as translational medicine consultancy. Its highly-customised and fully-compliant services are designed to optimise clinical trial design and reduce time-to-market, including liaising with regulatory authorities to ensure the protocol meets the required criteria. Data from clinical studies conducted at the clinical unit have been used to support MAA dossier in many regions worldwide, all with successful outcomes.