Clinerion: We recently got EHDEN-certified. What does that mean? What steps did the team have to go through and what’s our expertise regarding OMOP mapping?

Alexandre Vanobberghen:  Indeed, we are EHDEN-certified now: this gives Clinerion the opportunity to provide our services to any data provider – be it hospitals or research centers – wishing to convert any data set to the OMOP Common Data Model. The goal of this transformation is to allow the providers to enrich the available patient data to support medical research within the EU, principally, but also worldwide.[...]

[continued] 

In order to get certified, four Clinerion employees took the online EHDEN training course. Two of them went on to Rotterdam for the final face-to-face exam. We did not need to modify our solution or technology. Our Patient Network Explorer was already able to export to the OMOP standard, as a feature.

As a result of our certification, we have come into contact with many data providers in different countries, and discussions are in the final phase for OMOP-related projects with them. These providers usually have data from previous studies or live operational system. They now have a standard approach to transform this data to the OMOP common data model, in order to advance research at a higher level by feeding and using a larger pool of data across Europe.

On our side, we can convert any kind of data to OMOP, whether it is static or dynamic. Technically, we can also provide a service which includes an ongoing, live synchronization of dynamic data sets.

Clinerion: What’s the link between this data mapping and your daily job? What are your other activities on a daily basis; and in what direction to you see Clinerion evolve in the next months?

A.V.: Data mapping is core to our business. Every site joining the Patient Network Explorer (PNEx) ecosystem provides its own data in their own specific format that we need to map to the PNEx data model. This is the critical step to ensure that their data becomes usable to the highest quality possible, in order to make the patient search more accurate.

We have experts in the team (the “Delivery Team”) working on this process; we also take care of data analysis and project management. We have colleagues who focus all their efforts on the backend only, which is the “backbone” of this process.

My other activities? I mainly work on implementation project management and coordination, which consists of managing the integration of site into our network from the moment the agreement is made, all the way to the training with the clinical staff at this hospital. This includes management of data and terminologies and managing resources and technology implementation on both sides, as well as quality assurance. This is all really a team effort and my role is to ensure all the abovementioned activities are done properly, as a project manager.

It feels to me like Clinerion is at a very interesting phase of its story, as the company is growing massively and industry needs are also evolving. Possibilities are multiplying and we will need to adapt in a smart way as we go along – that's my view! Lately, we have been developing new interfaces for Real World Evidence within our main tool, as an example.

I look forward to seeing how we can support the clinical trial needs in the future! In any case, as an EHDEN-certified SME, we are ready to receive and work on new projects related to OMOP harmonization.

Clinerion: From your perspective, which is not only technical but also working with the hospitals, what is THE one thing hospitals usually need (or lack) the most?

A.V.: In the PNEx context, one of the biggest challenges is often about the level of systems integration and the way the data is structured within the hospital itself, meaning that the hospital collects data through disparate systems which do not always communicate with each other.

Consequently, the process of integrating data in the PNEx can be done in phases as more and more data becomes available from the hospital side – this requires some work on the hospital side, before it can join the PNEx network.

Another challenge is on data sharing and all the regulation around it, especially in the EU, which is clearly an important region for Clinerion.

Hospitals are very concerned about patient data safety. We take great pains to explain how our system respects all international data privacy principles and fully complies with all international regulations. All of our processes and policies are designed to ensure patient privacy. It is an important point for us that we do indeed take the necessary precautions – and beyond.

Retroactively, for historical data, some hospitals are taking measures to inform and engage patients more. For example, one of our partner hospitals in Europe has performed a campaign to inform their patients on how their data can be used for research, and how they (the patient) always keep control of their own data. They can decide whether they want to share it, deidentified. In any case, with our system, the data never leaves the hospital and is always deidentified, which guarantees the confidentiality of each patient's personal details.

***

< Back to Clinerion Expert Corner