About Us
BlueClinical is a privately owned independent full-service CRO focused on bioequivalence and early-stage clinical studies in healthy subjects and patients, translational medicine consultancy, and site management.
We 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.
MISSION
BlueClinical’s Mission is tailored to each business unit, as follows:
R&D: To provide consultancy services in drug clinical development and act as a full-service CRO for clinical studies in patients, with special focus on early phase studies.
Phase I: To conduct phase I clinical studies in healthy subjects and selected populations of patients, in strict compliance with the highest ethics and regulatory standards.
CRP: To support operationally the clinical research activity in partner health institutions, promoting its development, efficiency and excellence.
VALUES
Competence: Personnel qualifications, experience, talent and continuous training are important for the development and achievement of BlueClinical’s goals.
Integrity: Honesty and truth are essential in fostering strong relationships. We honour our commitments and we never compromise ethics.
Consistency: All aspects of our activities reflect our conduct. We walk the way we talk.
Compliance: Our documents and clinical data are accurate and satisfy the most rigorous regulatory standards, and clinical research participants are treated with dignity and professionalism. We strictly comply with our Standard Operating Procedures, Good Clinical Practice principles and all applicable laws and regulations.
Positive thinking: Challenges are to be overcome. We embrace every day with fresh will and we like challenging goals
Innovation: We seek and capture every opportunity to identify a competitive edge in terms of smart innovation and use creative approaches, aiming to create relevant and sustainable value for all the stakeholders.
Motivation: We are dedicated to sustaining trustable relationships between all stakeholders and we are daily motivated to do and improve our work.
Customer orientation: We are focused in achieving clients’ satisfaction and accomplishing the objectives with quality, in time and in budget.
QUALITY AND ACCREDITATIONS
BlueClinical's Quality Policy is centred on:
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Generating value for society, pursuing therapeutics innovation and effectiveness.
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Conducting research that meets all applicable ethical, scientific and regulatory requirements.
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Ensuring an efficient use of resources.
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Fostering a continuous improvement environment, recognising the contribution of each employee in the promotion of smart innovation and quality.
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Investing on training and qualification of human resources.
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Investing on adequate equipment and facilities.
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Promoting teamwork approaches and creating a supportive work environment that facilitates employees’ satisfaction and professional development.
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Establishing successful business partnerships that create value for clients and generate an adequate return on investment.
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Regularly reviewing its performance and the satisfaction of clients, to endorse improvement of services.
BlueClinical drives a process for monitoring performance and quality to ensure that a state of control is maintained for all activities, while striving for continuous improvement. This monitoring is performed during quality control and quality assurance activities.
BlueClinical Clinical Pharmacology Unit has been successfully audited by many Sponsors and successfully inspected by INFARMED and the US FDA. BlueClinical has been accredited by the French authorities to Crédit Impôt Recherche (CIR), and by the Portuguese authorities to tax credit (SIFIDE).
