Mission

Blueclinical Phase I's mission is to conduct effective studies in healthy subjects and early stage studies in patients, in full compliance with the international regulations.

Facilities

Studies in healthy subjects are conducted in Blueclinical's own phase I unit located at Hospital da Prelada, Porto, Portugal. Our up to 60-bed clinical ward benefits from its hospital location for access to logistic services and accredited clinical laboratory.

Competences

Our clinical and scientific team has long lasting experience in diverse types of studies for the global market, both with generics and innovative medicines:

  • Bioavailability/Bioequivalence studies according to the requirements of the EMA, US FDA and other regulatory authorities
  • Phase I studies with innovative medicines; Drug-drug interactions, effect of food, dosage form proportionality, entry-into-Man, and special populations

We strictly accomplish with international regulatory and ethical standards:

  • Quality Management System compliant with EMA and US FDA requirements
  • GCP-compliant as per inspection by INFARMED (EMA standards)
  • Audited and qualified as service provider by various pharmaceutical companies

We benefit from expedited regulatory review for Phase I clinical trials:

  • Short approval times: 3-4 weeks
  • Competent Authority (INFARMED) and Ethics (CEIC) reviews run in parallel

Access to Participants

Blueclinical Phase I has its own pool of healthy subjects registered at the National Data Protection Committee (CNPD) and National Ethics Committee for Clinical Research (CEIC).

The access to patient populations is facilitated through an established partnership with a group of hospitals and primary care units (“Blueclinical CRP”), in Portugal.

When clinical trials require large patient populations, an established partnership between Blueclinical Ltd and SCOPE International AG allows expedite patient recruitment everywhere in Europe and North America. With SCOPE's offices in 17 European countries and USA, we cover 25 countries by own 138 full-time CRAs experienced in neuroscience, psychiatry, pain/analgesia, respiratory, oncology, hematology, dermatology, women’s health, immunology, and infectious diseases.

Contact for Inquiries

Daniela Mar, PhD, MBA
Deputy Business Development Director
dmar@blueclinical.pt