Bioequivalence and Phase I Studies

BlueClinical provide highly-customized and fully-compliant services, to maximize client’s competitiveness and time-to-market. This includes liaison with regulatory authorities (including US FDA and EMA), when needed to ensure the protocol meets the required criteria.

Blueclinical’s own Clinical Pharmacology Unit (CPU) is in Porto, Portugal. Our 61-bed clinical ward benefits from its hospital location for access to logistic services and emergency support.

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: in healthy subjects or in patients, according to the requirements of the EMA, US FDA or other regulatory authorities.
• Phase I: drug-drug interactions, food effect, dosage form proportionality, first in human and special populations.

Blueclinical has its own database 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 Blueclinical Clinical Research Partnership constituted with twelve hospitals.

We benefit from expedited regulatory review for Bioequivalence and Phase I clinical trials. Reviews from competent authority (INFARMED) and CEIC run in parallel so your Phase I or bioequivalence clinical trial can be approved within 4 weeks.

At Blueclinical your early phase clinical trials are supported by validated software for data management and analysis. We use validated 21 CFR-Part11-compliant eCRF and SAS datasets are prepared in accordance with latest CDISC specifications from US FDA.

Blueclinical has been successfully inspected by INFARMED and the US FDA.