The EMA Is Talking About eSource Direct Data Capture. We’re Ready.

EMA handshake eSource in clinical trials

We’re in the midst of a watershed moment for eSource in Europe-based clinical research. The European Medicines Agency (EMA) last October released its qualification opinion on eSource direct data capture in clinical trials, and while the opinion doesn’t constitute official guidance or policy, it’s a big step toward laying the groundwork for the next frontier of the eSource revolution. The absence of regulatory clarity has hindered adoption of this next-level technology in clinical research in Europe, with organizations reluctant to invest before the EMA makes its position known.

Now it has – and Medrio is ready. Over the past several years, we’ve directed our engine of innovation toward building, releasing, and subsequently enhancing our eSource tablet application, in anticipation of the EMA eventually following in the footsteps of the FDA and warming up to eSource. And we’ve been pleased to see that the benefits of eSource that the EMA recognizes are very much aligned with the benefits we’ve built into our own platform.

 

The eSource direct data capture opinion and Medrio

There are several ways Medrio eSource reflects the EMA’s description of the benefits of eSource direct data capture technology. For a deeper discussion of the key takeaways from the qualification opinion and its alignment with Medrio eSource, we invite you to take a look at our new white paper, which you can find on our website. For now, we’ll focus on one major commonality: the impact of eSource direct data capture on the clinical trial monitoring process.

The qualification opinion notes that eSource direct data capture can yield a significant reduction in source data verification. This is one of the key features we’ve build into Medrio eSource. By enabling site staff to collect data electronically and sync it straight to our EDC, the platform cuts down on the need for data transcription from paper, thereby preventing the kind of transcription errors that are caught in the source data verification (SDV) process. The platform also enables real-time remote data sharing, which can significantly reduce the need for in-person site visits and the costly and time-consuming logistics that come with them.

With the burdens of SDV and site visits significantly alleviated, monitors can devote more time and energy to other crucial tasks – a value explicitly acknowledged in the EMA’s qualification opinion.

There’s more alignment between the EMA’s qualification opinion and Medrio’s own eSource platform – particularly in areas like data quality, patient safety, and security. For the full story, dive into the white paper. In the meantime, we’re excited to see the impact this opinion has on eSource adoption in Europe in the coming months and years.