Infrastructure

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.

Location

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

Description

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

AEMPS
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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