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Post-Market Clinical Follow-Up Studies in 5 European Countries

Objective

A multi-national European pharmaceutical and consumer health company required clinical data to validate the safety and performance of five of its nasal spray and allergy products post CE-mark, in accordance with MDR 2017/745 Annex XIV Part B.

Methodology

ObvioHealth designed and conducted all five of these post-market clinical follow-up studies, which were successfully executed in multiple countries across Europe. All study materials were translated into the primary languages spoken in each study’s location.

Digital recruitment for all five studies was designed to target a population that had used the nasal spray products in the past 6 months.  

Each study called for participants to complete questionnaires, which were designed to be simple and intuitive to keep compliance rates high. This also allowed for participants to report any adverse events or side effects experienced from using the product.

Results

Recruitment on all these studies was completed below projected budget. The studies reached completion before their targeted end dates, with an average duration of 48 days.

The sponsor was able to gain valuable insights into participant use and satisfaction with the product.

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