Life Science Leader Magazine Supplements

CRO Leadership Awards 2017

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OFFERING DEEP INSIGHTS INTO KEY AREAS OF CLINICAL DEVELOPMENT BIOCLINICA SEE MORE CLEARLY bioclinica.com Change management was an important consideration for bringing that large a group together. Management knew that moving forward with a complete outsourcing model would require buy in from key stakeholders at every level of the company. It was clear that this task would be challenging, but with the size of the company and its portfolio, it was a move that made the most sense for the company. One Development Engine And One CRO During the decision-making process, Curtiss notes she never believed the company would opt to align itself with just one CRO. However, she knew many pharma companies and their CROs often seem to have overlapping activities. That was something the biopharma business of Merck KGaA, Darmstadt, Germany wanted to avoid. "Trust is an important element between pharma and CROs," says Curtiss. "Oftentimes the CRO waits to be told what to do to ensure they get paid for doing it. But when that happens, they do not have any responsibility for what is being done because someone from the spon- sor company told them what to do. That dynamic doesn't work well." That is when the team came up with the idea of employing a model where there was a single development engine for the company. The model would ensure there was no duplication of effort and would feature an external development team that functioned as an inter- nal part of the company. There were questions around whether it could actually be done and even if there were a partner that would be willing to participate. Still, Curtiss and many of the team mem- bers felt this was something that could work. They also realized there was no way it could work with more than one CRO. No one would see the logic in having a "single" external development engine that consisted of more than one partner. Show Us What You Can Do To help with the selection process, the biopharma business of Merck KGaA, Darmstadt, Germany created a bid grid, which helped it We knew it would be a fully outsourced model, but other than that we were given no parameters or restrictions. As a team, we just needed to figure out how to get it done. LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 9

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