Decentralized Clinical Trials Solution

Case Study 

Decentralized virtual clinical trial on sleep  – data collection from the comfort of your home

Clinical study to explore tolerability and benefit of a dietary supplement for subjects with sleep complaints.

  • Very fast subject recruitment and very high compliance and retention rate due to the use of an easy-to-use electronic diary and only one in-person doctor visit.
  • The remote study approach was very well accepted across all age groups.
  • Less on-site visits and fast recruitment reduced costs of about 50% compared to a traditional study approach.
Age distribution chart
Age distribution chart

subjects recruited in 3 months

%

Questionnaire compliance

%

Retention rate

subjects recruited in 3 months

%

Questionnaire compliance

%

Retention rate

Methodology

  • At study start, there was a screening visit at the study site to check eligibility. Then, subjects consumed the dietary supplement for 3 weeks and recorded any study-relevant data in an electronic questionnaire via their own smartphone, tablet, or computer daily.
  • The electronic questionnaire was sent to the participants on a daily basis via email or text message. It contained questions regarding:
    • time in bed
    • time to fall asleep
    • number of awakenings in the night
    • total duration of wake time during the night
    • overall quality of sleep
    • sense of well-being during the day
    • tolerability
    • adverse events
  • The study team had a “live view” on subject progress by use of a connected dashboard and could quickly identify and re-engage subjects in case of missed data entries or in case any clarification was needed

Get in touch with us

We would love to hear from you. Here is how you can reach us: