In September 2019, the European Medicines Agency (EMA) released an important qualification opinion in favor of using eSource direct data capture (DDC) in clinical trials. The EMA response cites data and insights gained from numerous Phase I, II, and III studies using Clinical Ink’s eSource platform that provide real-world context for implementing and deploying eSource DDC in global studies.
In this webinar, Clinical Ink’s chief executive officer, Ed Seguine, and chief business officer, Jonathan Andrus, discuss the future implications of regulatory endorsements from organizations like the FDA and EMA and how sponsors and CROs can improve the way clinical research is conducted by adopting these eSource solutions today.
What you’ll find in this webinar:
- The implications behind the EMA’s qualification opinion
- eSource’s cost and time savings and the data accuracy improvements cited in the opinion
- Clinical Ink’s role in the Novartis trials identified in the opinion
- The best steps forward for the industry in light of the EMA’s announcement