The company carries out clinical studies at several clinical sites in Finland. The study subjects are healthy volunteers. Each and every clinical site has been appropriately inspected by the competent authorities. During the inspections, also the conduct of at least one study per site has been inspected.
The network of experienced and properly trained study personnel carries out the clinical stage of the study, over 20 studies have already been completed. The studies are reported and the study reports have been used as pivotal parts of the international marketing authorisation applications of the generic drug products. The study results, studies itself, and study reports have been verified to fulfil the requirements of the current GCP.
The company can provide the complete clinical study, from creating the protocol and trial form applications to the final study report (including the monitoring reports), or alternatively some agreed separate stages of the study could be conducted.