The report emphasizes the benefits of the qualification of SV95C by the EMA as a primary endpoint:
- This is the first qualification of a digital outcome as a primary endpoint by the regulator.
- This qualification of SV95C is a major milestone in the adoption of digital endpoints in the industry and paves the way for broader use in clinical research.
- It marks a pivotal shift in the use of digital endpoints from being just exploratory to becoming primary endpoints.
We are honored to have our achievement celebrated amongst pharma companies such as Roche, Johnson & Johnson, Takeda, Biogen, Novartis, and Koneksa.
