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Clinical trials

Clinical trials

Tequir I+D+i, has been one of the pioneering companies in Spain performing clinical trials for implantable devices. Our experience in the performance of various multi-centric clinical trials in Spain, with different pathologies and involving different clinical teams, has given us valuable know-how for the correct definition of the best suited clinical trial for the characteristics of the product.

Depending on the planned development stages during the management phase of the project, the technical team will study the existing clinical data and justify the Essential Requisites required in Directives 93/427CEE and 90/385/CEE, performing bibliographic validation studies or by means of the corresponding performance of a clinical trial.

The technical team of Tequir performs the following activities within the clinical validation by means of a clinical trial:

  • Elaborates together with the principal investigator the design of the Clinical Trial Protocol, (PIL) principal investigator logbook
  • Prepares all the necessary documentation, both for the evaluation of the corresponding Ethical investigation Committees (EIC) and the competent Healthcare Authorities:
    • Data collection logbooks, DCL.
    • Principal investigator logbook.
    • Technical file (risk analysis, labeling instructions, etc…).
    • Patient Information Sheet (PIS).
    • Informed consent model.
    • Economic reports.
    • Contracts with healthcare centers.

Besides they perform the following tasks:

  • Manage the insurance policy according RD 22/2004.
  • Coordinate the clinical teams and trains them in the new surgical technique.
  • Manage the necessary samples.
  • Monitor the clinical trial, issuing periodical reports to the competent authorities and involved Ethical Committees.
  • Prepare databases in such way that the users can enter data for its final analysis.
  • Manage the analysis of statistical data for the final results.

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