White Paper

Key Findings From The EMA's Qualification Opinion On DDC

Source: Medrio
Data Tunnel

Patient data is the key element that drives clinical research. The clinical research industry is transforming, becoming more adaptable to improve the way data is captured. Regulators are widely accepting the use of various technologies for the benefit of the key stakeholders in clinical research.

eSource is one such technological advancement, with various regulators and agencies starting to recognize the benefits of eSource Direct Data eSource is one such technological advancement, with various regulators and agencies starting to recognize the benefits of eSource Direct Data Capture (DDC). The latest of these regulators is the European Medicines Agency (EMA), which recently published a qualification opinion on the use of eSource DDC while conducting clinical trials. The opinion has been adopted by the Committee for Medicinal Products for Human Use (CHMP). Released by the EMA in October 2018, it presents the views of CHMP on the “regulatory acceptability” of eSource DDC and the potential benefits to the whole ecosystem.

The significance of this qualification opinion should not be underestimated. The reservations about eSource DDC that have long pervaded the The significance of this qualification opinion should not be underestimated. The reservations about eSource DDC that have long pervaded the European clinical research industry have centered largely on the regulatory uncertainty around it, and the EMA has now taken a big step toward clarifying that uncertainty and bringing a technological watershed moment to one of the world’s foremost regions for clinical research. This white paper will discuss key takeaways from the qualification opinion, providing readers the opportunity to learn its most essential components quickly and in a layperson-friendly format, without having to find time to consume the entire opinion in its original form.