ProofPilot | Design, Launch & Participate in Studies

Case Studies

Lilly DCT in Digital Health Research

A DCT was designed and conducted in ProofPilot Rx, enrolling 300 patients with Migraine and Tension Headache for digital biomarker exploration, using BYOD. As a true SaaS solution, ProofPilot Rx delivered enormous cost savings, accessibility, and agility.

In only 8 days of active recruitment, the trial was enrolled and collected the following data types in a BYOD model:
  • eConsent
  • ePRO
  • Wearable sensor data
  • Local weather (temp, precipitation, barometric pressure, air quality)
  • Location

Other Metrics

  • Cost: 67% less as compared to a leading digital CRO
  • Operating System: Android (49.8%) / iOS (50.2%)
  • Device Type: nearly 100% utilized both Mobile and Desktop ePRO Compliance: 80%

The Fisher Wallace Stimulator

The Fisher Wallace Stimulator® is a wearable neurostimulation device commercialized by Fisher Wallace Laboratories, Inc. The device had been used & prescribed for decades based on anecdotal feedback for depression, anxiety, and insomnia. When the FDA updated neuromodulation device regulatory guidelines, Fisher Wallace chose ProofPilot to conduct three registration studies.

In just six months using ProofPoilot’s end-to-end platform, with minimal clinical trial staff, Fisher Wallace: 

  • Designed & launched three studies in about 60 days 
  • Conducted all study tasks, including: 
    • Participant enrollment and screening
    • Informed consent 
    • Appointment scheduling 
    • Physician telemedicine screening visits and follow up
    • Conducted informed consent 
    • Randomized participants into active or sham device arms
    • All data collection including both physician data and participant self-reported outcomes 
    • Treatment adherence reminders and tracking 2 times per day for 3 months
    • Participant compensation calculation and distribution 
  • Transferred data digitally to a biostatistical vendor, regulatory vendor, and sponsor 

The study results lead to successful FDA clearance of The Fisher Wallace Stimulator® – one PMA for depression and two 510Ks for general anxiety disorder and insomnia.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541563. Source: ClinicalTrials.gov

Joovvin' Light Therapy Studies

Joovv used ProofPilot on several clinical studies, including the investigation of full-body red & near-infrared photobiomodulation therapy for mental health in the winter months. The study was conducted during the winter months in northern latitudes using the Joovv Mini 2.0 Device on self-reported non-clinical mental health, sleep, and energy levels. 

In just a few weeks using ProofPoilot’s end-to-end platform, Joovv: 

  • Launched the company’s first-ever clinical trial, paving the way for several more studies to come 
  • Designed & launched a Wait-list Cross Over study in less than a few weeks 
  • The study was 100% virtual and automated, all activities managed on ProofPilot 
  • Screened 200 participants in less than 24 hours
  • Enrolled 30 participants total 
  • Integrated with Joovv’s shipping and logistics systems for swift and secure device transactions 
  • Sold 90% of devices at the end of the trial  
  • Promoted results as Content Marketing directly to customers, ahead of next-phase launch

The trial was cost neutral versus many hundreds of thousands of dollars (or even millions) for a typical  consumer 510K medical device clinical trial     

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251000. Source: ClinicalTrials.gov.

 

Here are some other studies we’ve helped conduct!

See ProofPilot In Action

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