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Clinical Ink announced the European Medicines Agency (EMA) has signaled its support of eSource direct data capture (DDC) in a recent qualification opinion that specifically mentions Clinical Ink’s technology.
The EMA qualification opinion, requested by Novartis Europharm Limited, marks a turning point for European regulatory acceptance of eSource technology in clinical trials. Although the U.S. Food and Drug Administration (FDA) has endorsed eSource approaches for several years, the EMA had previously been cautious.
The opinion concludes that eSource DDC, when implemented correctly, is Good Clinical Practice compliant and can be used in support of regulatory filings. The 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.”
“This decision by the EMA is indicative of a larger shift happening in our industry in favor of eSource solutions,” said Ed Seguine, CEO of Clinical Ink. “As a pioneer of this type of technology, we are elated the EMA recognizes its potential to improve data quality. Clinical Ink’s eSource platform has been refined over many years and, unlike traditional EDC systems, was specifically built to account for the unique demands of eSource DDC.”
The regulators identified many areas where eSource DDC is different from traditional EDC. 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
“Unfortunately, we’ve seen a reluctance by some stakeholders to adopt innovative approaches,” said Jonathan Andrus, chief business officer at Clinical Ink. “Now, with the EMA joining the FDA to recognize this technology’s potential, we will hopefully see more widespread industry acceptance of eSource DDC.”