Clinical Study on a Dietary Supplement for Sleep Improvement

Using digital solutions to query tolerance in test subjects

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As part of a study for a sponsor from the pharmaceutical sector in 2020, Berlin-based Contract Research Organization analyze & realize GmbH conducted a study with around 300 subjects. The aim was to investigate the benefits and tolerability of a dietary supplement in healthy subjects with sleeping problems. Climedo’s electronic patient diary ("eDiary") was selected for this purpose.




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Study duration

The Project

With the help of Climedo Health's eDiary solution, the monocentric study at analyze & realize GmbH was successfully launched in October 2020. As part of the project, Climedo's electronic subject diary was sent to subjects on a daily basis via email or SMS for three weeks. This diary contained up to 20 questions about the subjects’ intake of the study drug and its effects on their sleeping problems. To pick up subjects on a technical level right at the beginning, they received a mock eDiary on the day of admission to the center to get an idea of the structure of the diaries and how to fill them out. After their first visit to the center, all questionnaires could be answered from the comfort of their own home using their computer, tablet or smartphone. This also saved them unnecessary center visits.


The results so far show that more than 99% of all surveys have been completed in full. Overall, Climedo has proven to be a great relief in data management since the answers are very easy to read for the CRA(s). Another great advantage is to be able to see the current data situation as well as the progress in real time. Thus, with the help of Climedo's "Smart Views", specific data filters can be saved and called up with just one click. This provides a quick overview of the development of particularly important core elements of the study. The quality of the data was also praised. Even for subjects aged 50 or above, the study ran smoothly following a short training session with the digital survey.

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