Open Hand

Overview

The Open Hand project offers a unique approach to the regulatory review process in which IVD manufacturers engage with an interactive review session and share learnings between sponsors to advance the understanding of fit-for-purpose RWD to generate RWE.

COMING SOON

New Release on Facilitating the Use of RWE

Be on the look out for our newest publication! The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency 

View All Resources

Open Hand Working Group

Active Open Hand Working Group members represent the following IVD stakeholders:

  • Becton Dickinson
  • Roche
  • Siemens-Healthineers

Explore ClinDx Resources

Standardizing Clinical Data for In Vitro Diagnostics

Study Design Blueprint for Evaluating Analytical Performance Characteristics of Point of Care In Vitro Diagnostic Devices with Capillary Whole Blood (Fingerstick) Specimens

Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)