Life Science Leader Magazine Supplements

CRO Guide 2016

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 9 To help cut down the administrative burden of site monitoring, we've built a one-stop digital environment that empowers your team to get more done (in less time). With features like site visit templates, real-time progress charts, an embedded discussion channel, and instant trip reports, you'll no longer worry about getting your forms flled out – or wonder what your team is doing. Now it's all online, all in one place. Now you can focus on your work, not your paperwork. Introducing Monitor Management for Clinical Site Monitoring Teams Email to learn more or visit Enrolled Complete SDV Complete Subject: Enrolled 75% Count 15 Activity Total Subjects Reviewed Page Status Changes Sdv Fields Set Queries Opened Queries Answered Queries Closed 15 1 2 1 4 2 450 separate qualifications. That can become a huge problem for both the sponsors and the sites. "What pharma companies are doing via TransCelerate is just a much smarter way for all of us to do business," says Sanders. "Members have agreed to a set of mini- mum criteria to enable a voluntary mutual recognition process of GCP Training across member companies. This allows clinical trial investigators and other site personnel to complete GCP training, which may be recognized by other TransCelerate member companies, making it unnecessary to train separately for each participating company. That is a huge relief for any investigator site. It is an investi- gator-centric approach that we feel will greatly ease their lives and help pharma get medicines to patients faster." L serious collaboration. The structure that Dalvir [Dalvir Gill, CEO of TransCelerate] put in place has made it successful. At the industry level, I think we will continue to see this type of cross-company collaboration." One success story that Sanders proudly states has already come out of TransCelerate is the Site Qualification Training Program. At Roche there are several clinical operations groups, and by design they all operate independently. That means an investigator working with Roche may have to be trained several times. Taking that to an even higher level, staff at a site working with multiple com- panies may have to go through the same training multiple times. If there were just 15 individuals working at that site needing 30 training instances, it would result in we don't and where working together is smarter. We have an internal theme within Roche product development that's called Smarter Together. We want our people to feel that is the best thing for us to do." Externally, Sanders believes there has been a major shift in thinking across the industry. Roche was one of the first 10 participants in TransCelerate, and when she was first called about participating in it, her response was "Forget it." "I was certain that nothing was going to come out of it," she now says with a smile. "I was very cynical of the whole effort. I felt there would be a lot of talking back and forth, and it would take five years before anything would be approved. But after attending just one meeting, I realized it would be a

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