GDPR: New Considerations and Shared Experiences for Life Sciences Companies

OCT Europe 2018 recently wrapped up in Barcelona. OCT provides a forum to discuss outsourcing for clinical operations and the emphasis of this year’s event was on technology and innovation. Like most conferences, the speakers covered quite a bit of subject matter across many topics. However, as always, themes emerge. A few keywords mentioned repeatedly throughout the conference were:

•     Trust
•     Accountability
•     Innovation
•     Technology

Here are a few of my thoughts and observations on the last two: innovation and technology.

During the two days of the conference, I had many discussions with heads of clinical operations and CRAs across a wide range of companies (CRO and Sponsor) of varying sizes and across generations of professionals. During formal speaking events and during informal conversation, there was, as expected, a lot of talk surrounding the relationship between Sponsor and CRO, their dependency on each other, and aligning behind the objective of Sponsor companies to expedite time to market for new treatments.

The conversation about agility in bringing treatments to market inevitably revolves around technology and clinical business process innovation. One thing became clear to me in listening to the dialog between industry peers: while clinical professionals frequently discuss e-clinical technology, there is no explicit agreement or mutual understanding on how much innovation is truly desired, or perceived as good, for their operations.  

As ubiquitous as technology has become, not all organizations have been quick to adopt emerging e-clinical technology. While Generation X and incoming generations are digital natives who do not know life without technology, many of their more senior peers have experienced a life of both analog and digital realities. These differences in experience mean differences in expectations and opinions about what makes for effective work environments. Where the Generation Z professionals tend to accept constantly evolving technology and technology adoption as part of life, previous generations often express more varied perspectives on technology adoption, with some hesitant to take the leap due to a lack of belief in the productivity gains or even a perceived threat.

As is always the case, generations have a lot to learn from each other. Generation Z can gain a nuanced view of technology by learning from their less technology-reliant peers. At the same time, technology will define the future of clinical operations and therefore it is important for clinical professionals across generations to acknowledge and participate in the trends to continue to remain relevant and to push the upper limits of productivity potential.  

A few weeks ago, my 5-year-old daughter found a green floppy disk (maybe the last one on Earth) that was still laying around at home. For some reason, it caught her attention. She asked me what it was and I explained it was like a CD (another dated, but not yet extinct, technology). She asked me if I could show it to her on our PC. Needless to say…I could not.

I tell this story because in Europe, the adoption of technology platforms like eTMF is still far lower than the US. There are many technology hold outs or companies who have chosen technology that is the e-clinical equivalent of a floppy disk. Numerous companies are still using paper or non-compliant systems. At the same time, more and more Sponsors expect their CROs to have an eTMF system in place. However, once the study is ready, even many Sponsors are content to receive a pendrive, CD/DVD, or even paper instead of having the TMF stored/transferred to a secure, cloud-based system that is ever available.  

Emerging e-clinical innovation has a lot to offer European companies. For example, several CRAs—some using variations of TMF technologies and some still on paper—mentioned how time consuming it was to still have to go to the sites, get set up with available scanners or portable scanners, get codes, etc. Once back at their offices, they would needed to get information into their TMF. They all wished for a way to speed up this process, perhaps being able to use their phones to scan documents.

When I told them this actually existed, and that they could not only scan documents but also apply the metadata and publish directly to the eTMF (among other mobile TMF work streams), they reacted as though it was the greatest news they had ever heard. Interestingly, some years back we brought up mobile eTMF during previous TMF conferences, and people were shaking their heads in disbelief that mobile eTMF would ever see the light of day. I bet they would be in further disbelief to learn that such an application can, in many cases, reduce weeks of work to mere hours.

At Trial Interactive, we love participating in the innovation dialog with clinical operations professionals around the world. OCT always provides an incredible opportunity to continue the conversation and learn about how professionals are thinking about adopting technology for their operations. Our mission is to help their teams work efficiently, save time and money, and eliminate compliance risks. While innovation may often feel like a buzzword, for us, it is something we take very seriously and that we work hard to deliver in the most practical, flexible fashion for our Sponsor and CRO clients. With different companies and professionals ready for different degrees of innovation and technology adoption, Trial Interactive provides a nuanced and responsive approach to make innovation accessible.