BlueClinical – Research and Development in Health, Ltd.

BlueClinical – An Astrum Company: Phase I Clinical Research Unit

BlueClinical – Research and Development in Health, Ltd., is a research entity founded in Portugal in 2012 and integrated into the Astrum CRO Group since 2023. The company operates a Phase I Clinical Trials Unit, whose mission is fundamental to the development of new, innovative, and generic drugs.

The unit is dedicated to conducting Phase I studies in healthy volunteers and selected patient populations, ensuring strict compliance with the most demanding international ethical and regulatory standards.

Location and Safety Infrastructure

The Phase I Unit is strategically located within the facilities of Hospital da Prelada, in Porto. This hospital setting provides privileged access to hospital support and emergency services, ensuring the necessary safety conditions for all study participants.

• The Clinical Pharmacology Unit has more than 60 beds and is managed by a clinical and scientific team with extensive international experience.

• Most studies are conducted as single-center studies within its own facilities, ensuring consistency in procedures and the production of high-quality data with reduced delivery timelines.

   

Scope and Experience in Human Pharmacology

• BlueClinical – Research and Development in Health, Ltd. has installed capacity for "full-service," including study design, approval submission, clinical conduct, and clinical trial reporting, supporting the acceleration of clinical development from First-in-Human to Proof-of-Concept.

  BlueClinical Phase I hosts a database with more than 17,500 registered volunteers and has experience in over 260 trials, covering the full spectrum of Human Pharmacology studies for new drugs and generic bioequivalence, including complex designs and formulations:

• Safety: First-in-Human, Single Ascending Dose Studies, Multiple Ascending Dose Studies, QT/QTc interval evaluation.
• Pharmacokinetics: Relative bioavailability and bioequivalence (including studies for drug registration in Brazil, as it is a unit certified by ANVISA).
• Pharmacokinetics in Special Populations: Evaluation in patients with renal and/or hepatic impairment.
• Pharmacodynamics.

• Drug Interactions.

   

International Compliance and Certifications

• BlueClinical Phase I operates in compliance with the guidance of major global regulatory authorities:
• EMA (European Medicines Agency)

• FDA (Food and Drug Administration in the United States of America)

  BlueClinical has been inspected:

• 4 times by INFARMED
• 1 time by NRPA (National Pharmaceutical Regulatory Agency of Malaysia)
• 3 times by the FDA, always resulting in NAI – No Action Indicated.  
• 2 times by ANVISA (National Health Surveillance Agency of Brazil), obtaining certification as a bioequivalence center.
• 1 time by GCC (Gulf Cooperation Council), obtaining certification as a bioequivalence center

Adherence to the most rigorous ethical and regulatory standards positions BlueClinical as a strategic asset for Sponsors needing internationally accepted clinical research data, reinforcing Portugal's role in the global biomedical research ecosystem.