eClinical Immersion, 2


Applied Clinical Trials

I thought when I got back from ClinTech 2013 I would be out of eClinical for awhile. But I was wrong.

As I noted in that blog, there appears a lot going on in eClinical now compared to the past two years. And I found out another reason why… software solutions are so much better now.  After the EDC lag, where it took many years for full adoption, and after the first tricky forays into integration, now the questions are optimizing on what you have, or taking on more e for what you don’t. How much data do you really need to collect? How much has to be integrated? And how wedded will you be to what you choose now and five years from now?

Here are some more highlights from the ClinTech 2013 conference:

People. For a conference that is about technology, there was definitely a lot of talk around people, culture and change management. That is, how people are using the technology and how processes—or even jobs—are changing because of technology.

eTMF. As has been described to me, eTMF is the “minutae of the minutae.” Getting your trial master files organized Electronically with Metadata requires thinking differently and beyond a paper-based filing system. There is a change management issue around eTMF, and there is also a large implementation effort involved. Not four months, as attendees mentioned some vendors would have you believe, but definitely less than four years, according to presenters. The eTMF group is very dedicated and collaborative. Some vendors are involved and actively promote involvement in the TMF Reference Model workstreams, which grew out of a DIA SAIC. And as I learned, TMF can also mean Too Much Fun.

Risk-Based Monitoring. Not the venue I thought I would hear a lot about risk-based monitoring. I thought that would be more of a clin ops thing. But what can support a risk-based monitoring strategy but data and signals in that data? For that, Bayer’s Head of Global Data Management Johann Proeve described the site data Bayer collects in its EDC platform that can be drilled and then outputted to identify particular problems at the site that requires monitor attention.  They have not yet implemented an actual risk-based, targeted or in-house monitoring plan, however, that will be later in the year. Proeve is confident his departments’ data is the heart of risk-based monitoring and he had many supporters in the audience for that view.

The Cloud. During one session, and broken into two groups, we discussed the viability of the build, outsource or host via software-as-a-service if we were a small biotech. The groups were led by James Streeter, Executive Director, IT Development for PPD and Kevin Johnson, Business Infrastructures Project Manager for Teva Pharmaceuticals, who both also presented. Discussion here was around the costs of the build and or maintain legacy systems; whether or not a CRO should be focusing on being an IT company; and the Cloud. There was no consensus, except that the first choice was not a viable option. Even the second was in jeopardy because of the lack of software programmers interested in working for a CRO.  In later discussion, people seemed to agree that the Cloud makes sense now, but in five years, the industry may be thinking something differently.

Other hot topics? There was a whole track on Portals that I didn’t even get a chance to sit in on, but were highly attended. Also, a session on how Genentech/Roche has implemented eMonitor, an iPad app for on site monitors.

To be honest, technology is the underpinning of everything the industry does. Finding the right technology and making the choices and rolling out the training and implementation is a big part of the attendees daily life. And how do people find out about new technology? Where do they go? Well, I overheard that the truth is they find the new cutting-edge technologies at conferences just like this.


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