


Astrum is a next generation Contract Research Organization that brings together scientific depth and operational innovation to deliver clinical trials that advance regulatory outcomes and strengthen long term value for biotech and pharma partners.
Regulatory Excellence
Across Phase I–IV & RWE, including oncology, neurology, immunology, vaccines, and rare diseases.
European reach with global regulatory expertise
(EMA, FDA, ANVISA).
Astrum CRO is a global Contract Research Organization supporting clients from emerging biotech innovators to leading pharmaceutical companies. With audited clinical facilities across Europe, including a dedicated Phase 1 unit in Porto, and a trusted international partner network, we deliver Phase I to IV & RWE clinical trials that meet the highest standards of speed, quality, and regulatory compliance, including EMA, FDA, ANVISA, and ICH GCP.
Our expertise spans early phase and late phase clinical development, with customized solutions in hematology and oncology, neurology, immunology, and other complex therapeutic areas.
What sets Astrum CRO apart is our adaptive approach, from building robust data packages that support biotech fundraising and key development milestones, to executing large multi country studies for global pharmaceutical sponsors. With a proven audit track record, long term client partnerships, and a reputation for reliability, flexibility, and scientific excellence, Astrum CRO delivers results that move science and business forward.
EMA, FDA, ANVISA compliance
Data packages for milestones













Trusted by biotech and pharma leaders worldwide
“Astrum successfully delivered our First-in-Human oncology trial on time and audit-ready. Their ability to design a study that met both EMA requirements and our investors’ due diligence needs made them a true strategic partner.”
“Astrum’s Phase I team delivered clear, proactive communication and excellent execution. Trial conduct was smooth, timelines were met with impressive speed, and the Phase I unit’s ability to hospitalize and randomize 32 patients in a single day was particularly impressive, alongside fast turnaround on documentation and TMF requests.”
"The multi-country Phase III study execution was flawless. Astrum's regulatory expertise across European markets saved us months in approval timelines while maintaining the highest quality standards."
“In this double-blind, randomized, placebo-controlled, dose-ranging, multicenter Phase 2 trial, Astrum demonstrated fast, reliable responsiveness and a highly proactive approach. Their solution-oriented support, including strong data management input during CRF development and close collaboration on regulatory responses, was instrumental to the smooth progress of the study.”
"I have everything I need and a day ahead of the timeline! You and your whole team continue to rock!”
“Thank you and your team for the excellent quality in the two recent studies you have conducted. I am very impressed by your professional standards and excellent timekeeping.”
"Our study has been really challenging at times, but you showed tremendous professionalism and resilience throughout. I appreciate all your team’s support!”
“We were searching for ways to manage specific data and you proposed a tailor-made, professional solution which followed all the medical, technical and regulatory requirements!”
"Please convey our thanks from us to the entire Astrum team for finalizing the report. Your precision in creating the report was an essential foundation for the quality of the report. Thanks!"
Discover how Astrum supports biotech and pharma with end-to-end
clinical trials designed for success.