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Tel: +387 33 771 700 | Fax: +387 33 771 707 | apomedical@apomedical.ba | BHS | EN

Clinical trial of medicinal products implies every testing on humans with the aim to: find or confirm clinical, pharmacological and/or pharmacodynamic effects of one or more medicinal products which is being tested; detect adverse effects on one or more medicinal products, as well as the clinical part of testing of bioequivalence and bioavailability of one or more medicinal products for the purpose of confirming safety and efficacy of the medicinal product(s). Clinical testing should be conducted in accordance with ethical principles derived from the Helsinki Declaration, according to the guidelines of Good clinical practice, International Conference on Harmonization and other valid regulations.

 

 

 

Apomedical's Department for clinical material is located on the ground floor of 35 m². The department is regularly controlled to ensure proper storage of medicinal products for research purposes and other material for clinical studies in order to prevent the possibility of contamination or errors during the procedure of supplying the clinical material. An adequate area is provided for safe performance of activities.

Our services include:

  • Receipt of material for clinical studies,
  • Inspection of inventory discrepancies, damaged packings or broken shutters,
  • Transfer of clinical study material to the test site,
  • Redistribution of returned medicinal products for research purposes,
  • Destruction of clinical study material or return of clinical study material,
    to the company for which Apomedical conducts the study,
  • Solving of deviations / non-compliances and complaints,
  • Back-up plan in case of temperature deviation,
  • Back-up plan in case of fire.