Clinical trials unit

Unidad de ensayos clínicos

The Clinical Testing Unit boasts a multi-disciplinary team that specialises in designing and carrying out clinical trials under the umbrella of pharmaceutical research, as well as nutritional studies and epidemiological research.

Experience, quality, problem-solving ability and great recruitment potential are the hallmarks of this unit.


Unit located in the University Hospital of Álava (HUA) in Vitoria-Gasteiz.


We are part of the Clinical Trials Unit in the Basque Country. We are located in the Araba University Hospital (HUA) and are part of the HUA Research Committee.

Bioequivalence studies:

We carry out bioequivalence studies on all types of drugs, administered by different routes and various experimental designs, carried out in one or more phases: inhaled, oral, sublingual, parenteral and hormonal, among others.

Phase I clinical trials:

  • First administration in humans.
  • Pharmacokinetics / pharmacodynamics
  • Interactions (drugs/ food / alcohol).
  • Drug tolerability and safety.

Nutrition clinics:
We carry out clinical studies designed to demonstrate the safety and efficacy of ingredients, food supplements and functional foods.

Turnkey projects:

  • Design and assessment of study documentation and databases.
  • Submission of trial documentation to regulatory authorities and CRECs.
  • Pharmacokinetic analysis (PK), pharmacodynamic analysis (PD) and relationship to PK/PD
  • Statistical analysis and reports.
  • Drafting and reviewing of final clinical trial reports.

Management of external studies:

  • Collaboration in the design of the study documentation and management of authorisation and contracts.
  • Management of the trial master file.
  • Data management.
  • Review of the clinical report.

Aimed at:

  • Generic drug laboratories.
  • Pharmaceutical laboratories.
  • CRO.
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Certifications and Accreditations

TECNALIA Clinical Testing Unit is accredited by the Spanish Agency for Medicines and Healthcare Products (AEMPS). Positive inspection result - Clinical trials and Bioanalysis. Activity framed within the Good Clinical Practices (GCPs)

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