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Tecnalia. Inspiring Business

Tecnalia. Inspiring Business

Clinical Trials Unit

The Clinical Trials Unit offers a comprehensive, reliable and efficient service in most of the clinical stages in the development of drugs and products requiring clinical validation.

The extensive experience, the quality, and the response capacity and the great potential for recruitment are the uniqueness of the Clinical Trials Unit at TECNALIA, the only one in the Basque Country.

TECNALIA is part of unique Clinical Trials Unit of the Basque Country. It is located at the Araba University Hospital (HUA).

TECNALIA participates in the Research Commission of the HUA

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BIOEQUIVALENCE STUDIES

Extensive experience in bioequivalence developing of all kinds of drugs administered by different routes and experimental designs, including studies with large numbers of volunteers - executed in one or more stages:

  • Inhalers.
  • Orals.
  • Sublingual.
  • Parenteral.
  • Hormones.

CLINICAL TRIALS IN PHASE I

  • First in human (FIH).
  • Pharmacokinetics / Pharmacodynamics.
  • Interactions (Drug / Food / Alcohol).
  • Drug tolerability and safety

CLINICAL TRIALS IN PHASE II, III & IV

TECNALIA disposes central services from the Araba University Hospital (HUA), necessaries for the selection and follow up of participants in the trials within the medical specialities that comprise the HUA.

CLINICAL NUTRITION

Clinical trials designed to demonstrate the safety and efficacy of active ingredients, food supplements and functional foods.

TECNALIA is spezialised in the design, implementation, coordination, monitoring and analysis of clinical trials of of high quality nutritional clinical trials.

The Clinical Trials Unit has experience in developing clinical trials with nutritional supplements for top companies in the national and international market.

CLINICAL VALIDATION

Biomarkers, prognosis/diagnostics systems and medical devices.

TURNKEY PROJECTS

  • Design and / or evaluation of the study documentation.
  • Managing regulatory authorities and IRB/IEC submissions and approvals.
  • Database design, data entry and queries management.
  • Pharmacokinetics (PK) analysis, pharmacodynamic (PD) analysis and PK / PD relationship.
  • Analysis and statistical reports.
  • Writing and / or review of final reports

MANAGEMENT OF EXTERNAL STUDIES

  • Collaboration in the design of the study documentation and management of authorizations and contracts.
  • Monitoring.
  • Management of the Trial Master File (TMF).
  • Data management.
  • Review of the Clinical Study Report (CSR).

 ACREDITATIONS AND RECOGNITIONS

  • ISO 9001
  • Good Manufacturing Practices (GMP) - Pharmaceutical development and manufacturing.
  • Good Laboratory Practices (GLP) - Pharmaceutical development.
  • Spanish Medicines Agency (AEMPS) inspection with positive result - Clinical trials and Bioanalysis.
  • We work under Good Clinical Practices (GCP) - Clinical Trials Unit.

Access to our Acreditations and Recognitions

LINES OF INNOVATION / AREAS

  • New pharmaceutical release forms.
  • Reformulation of active ingredients.
  • "Reprofiling" of brand drugs.
  • Clinical trials of inhaled medications.
  • Development and clinical validation of food supplements.
  • Monitoring of allergenic extracts.
  • Diagnostic, prognosis and response to drug tests.
  • Companion Diagnostics.

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Contact

Eider Larrarte Lázaro

M. +34 677 152 891


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Parque Científico y Tecnológico de Bizkaia. Astondo Bidea, Edificio 700. E-48160 Derio. Bizkaia (Spain). Tel.: 902.760.000 - International Calls: (+34) 946.430.850


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