Clinical Research

Clinical trials are scientific investigations focused on the investigation of the efficacy and safety of new drugs. They are designed aiming to provide answers to scientific questions related to prevention, diagnosis and treatment of diseases.

By conducting clinical research we develop therapeutic treatments for diseases aiming at more efficient healthcare, improved quality of life and expansion of treatment options.

Clinical Trials Categories:

Interventional Clinical Trials

Interventional clinical trials are conducted in humans and are intended to define and document the indications, safety and efficacy of an investigational drug with simultaneous determination of side effects and clinical and pharmacological characteristics.

Non-Interventional Clinical Trials

Non-Interventional Clinical Trials are those studies in which the drug is prescribed based on the instructions contained in the marketing authorization and under the protocol of the study, patients are not included in any additional diagnostic or therapeutic intervention.

Classification of Clinical Trials:

  • Phase I study (interventional): carried out with the participation of a small number of healthy volunteers. Purpose of the study is the initial and of short duration test of the medication.
  • Phase II study (interventional) performed involving small numbers of patients. Purpose of this study is to estimate the initial dose and the therapeutic effect of the drug.
  • Phase III study (interventional) performed with the participation of a large number of patients. Purpose of this study is to evaluate and determine the therapeutic effect of the study drug and the adverse effects thereof.
  • Phase IV study (interventional or non-interventional): carried out after the approval of the drug. Purpose of the study is to define with precision the approved indications of the drug.