Digital endpoints whitepaper

An end to end approach to managing wearable devices through clinical development.

Digital endpoints are becoming an integral part of drug and device development.

As the industry moves forward to using more Real World Evidence and virtual / decentralized trials, digital endpoints will become a necessity. Pre-register to receive our whitepaper which will explore why digital endpoints are important, and the benefits they can have for a trial or drug/device development plan.

We explore a framework for successful digital transformation including:

  • Study objectives (type of data, blinded/unblinded, therapeutic area)
  • Patient-centricity (compliance, patient burden assessment, user friendliness, engagement)
  • Devices (validation, fit for purpose, connectivity)
  • Security and data privacy
  • Big data and AI interrogation/analysis
  • Patient & sites support and training
  • Regulatory developments and considerations

The whitepaper will explore the challenges and weaknesses in using digital endpoints and how can they be addressed, how digital endpoints can be successfully incorporate in a trial or observational study, and how to make data clinical relevant and credible for regulatory bodies. 

 

Digital endpoints whitepaper

Available mid-June. Pre-register now to receive on publication.