An interview with Dr. Raphaela Schnurbus, Clinical Solutions Director at CRO OPIS
In this interview for PCT TV at Partnerships in Clinical Trials Europe (Nov 2017), Dr. Raphaela Schnurbus, Clinical Solutions Director at CRO OPIS, discusses the challenges around the mass of clinical data being collected from different sources.
RS: ‘The big challenge at the moment is to manage all the analytical and Artificial Intelligence. We need technologies to support this, to manage all the big data that is coming out of clinical trials.
What is really needed in clinical trials? We know that the process is long and complex... We need a technology that can combine and be one source. So for EDC platforms - electronic data capture - many companies have their own platforms and many service providers offer their own platforms and the aim is to keep it all in one source.
The real challenge here is to combine different technologies from other data sources and stakeholders in the trials... The important point is to have the compatibility so that the systems and the technologies can speak with each other.
We have a lot of help on the market. We all know that trials are succeeding or failing due to to recruitment, so we have platforms that help to manage recruitment, to retain patients, to engage patients. We all know that on mobile devices or tablets via apps, we can do patient electronic diaries.
We already speak about electronic informed consent, but this is still a big challenge. The first electronic informed consents were performed, but some of them failed. Why? Because they are ethics were not aligned we were not ready to manage this. So the big challenge here is to not only to have the technologies available and to combine them and have them in one source, but the various stakeholders of the trial need to be prepared.’
RS: ‘The biggest change for sure is linked to the management of big data, and the data processing that needs to be guided and protected as it is moved from one source to another, from one stakeholder to another, not only at a local level, but at international level. Still each geographic area has its own guidelines and rules.
So I think data processing, data protection, data privacy is a big question not only for lawyers, but for all the stakeholders, the authorities, for pharma/biotech companies and for service providers. All are involved and touched by this.
In our company there are some very challenging situations where we need to protect data from European companies and non-European companies. There's the globalization of trials and as the trials get more and more global, they get more and more complex and that means that costs are rising... To be more aligned and streamline all the processes means there will also be more efficiency which will save money.’
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