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OCT Clinical Has Received Approval to Conduct a III-Phase Study in Armenia

An American multinational pharmaceutical company which works with OCT Clinical has received approval for the start of a Phase III clinical trial in Armenia.

This study is designed as a multicenter, parallel-group, observer-blind, randomized, single-dose, non-inferiority clinical study of Flurbiprofen compressed lozenge in subjects with recent-onset, moderate-to-severe sore throat due to upper respiratory tract infection (URTI). The primary objective is to demonstrate the non-inferiority of Flurbiprofen compressed lozenge to a comparative drug with respect to 2-hours post-dose pain relief in subjects with recent-onset, moderate-to-severe sore throat due to URTI.

The overall aim is to involve 20 investigative centers in Armenia. Trial participants are subjects of both sexes aged over 18 years. The duration of the treatment is one day, and the follow-up period can be up to 3 days.

The next crucial milestones would be to arrange contracts with sites in Armenia, warehouses, and procurement, and to release IP documents collection.

Within this project, the OCT Clinical team is responsible for a wide range of services: project management, site initiation and management, data management, statistical analysis, medical writing, medical monitoring, clinical monitoring, logistics, pharmacovigilance, quality assurance, and regulatory support.

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