Qualification Opinion

Qualification Opinion

EMA Greenlights eSource DDC and References Clinical Ink

October 9, 2019

In late September, the EMA released an important qualification opinion in favor of using eSource direct data capture (DDC) in clinical trials. The EMA’s opinion presents a series of eSource-specific questions and answers, and makes numerous recommendations for implementing eSource DDC technologies.

The EMA response was requested by Novartis Europharm Limited and cites data and insights gained from numerous Phase I, II, and III studies using Clinical Ink’s eSource platform to provide real-world context for the business benefits and implementation use-cases of deploying eSource DDC in global studies.

The opinion concludes that eSource DDC, when implemented correctly, is GCP-compliant and can be used in support of regulatory filings. The regulators identified several critical differences in capturing source data electronically as opposed to simply implementing a traditional EDC system. This opinion also serves to eliminate the perceived uncertainty between the FDA’s previous endorsement of eSource. 

Notable metrics cited in the Novartis business case include:

  • Time to data availability dropped six-fold.
  • Number of data points that remained unchanged throughout the study increased 7%, indicating fewer changes because of data queries or monitoring.
  • Time to resolve data queries dropped by more than half.

This and other evidence led the EMA to state in its opinion that, “eSource DDC has the potential to improve quality of data and lead to operational efficiencies.”

Regulatory endorsements of eSource technology from organizations like the FDA and EMA make it easier for sponsors and CROs to implement the kind of innovative technology that is revolutionizing the way clinical trials are conducted. As an industry pioneer, Clinical Ink is lighting the way forward.

Find out how our technology brings you an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. Clinical Ink’s interconnected eSource ecosystem illuminates your data and empowers you to make well-informed, confident decisions.