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CRO Leadership Awards 2017

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Inside A Massive Outsourcing Shift When the biopharma business of Merck KGaA, Darmstadt, Germany made the decision a few years ago to outsource all of its clinical trials to QuintilesIMS, it created a challenge Jacqueline Curtiss and her colleagues would have to solve. Curtiss is the global head of clinical trial management at the Biopharma business of Merck KGaA, Darmstadt, Germany and was part of the team tasked with overseeing the process of moving all trials, including those being conducted internally and at other CROs, to its new partner. Moving just a single trial from one CRO to another can be a challenge, but Curtiss notes moving all of your ongoing trials to that one provider required a tremendous undertaking. A clinical trial cannot be moved overnight, and transi- tioning those trials to the new service provider took approximately two years to complete. "The first thing we did was perform a gap analysis to determine if it would be feasible to transition all trials in progress," says Curtiss. "We had studies that were close to completion, either in-house or at another CRO. If it made sense to finish rather than transfer them, that's what we did. The main priority was maintaining proper treatment for patients involved in the studies and ensuring there were no disruptions. All other concerns, including cost and time, were secondary. When a patient showed up at their site for a visit with their physician, we wanted that to be a seamless experience for them." The first trials transferred were the ones most recently launched or in the process of being launched. Transition teams at both companies were created to ensure the transfers were conducted smoothly and properly. The process was complex and often required the company to pay the new CRO for work that was already completed by another provider. "This was a massive effort," states Curtiss. "Contracts that were already in place needed to be changed. Documents had to be refiled with regulatory authorities in all of the countries where we operate, and sites needed to be notified. Some of those documents were very complex, which contributed to the challenge of the transition." Maintain The Right Skill Sets Throughout the process, retaining top talent was a priority — qualified people to continue the work during this transi- tion. At the same time, QuintilesIMS needed to make sure it had staff available and prepared to take on the additional work. Finally, the individuals maintained internally also had to have the right skill sets. For example, someone who was leading a trial in-house might not have the skills and experience to manage a study that was outsourced. Curtiss notes this was a critical part of the conversion effort, as the two jobs require entirely different skill sets. "Managing a CRO is not as simple as saying, 'I know what work needs to be done, so I am capable of telling someone else what they need to do,''' adds Curtiss. "Teaching people how to lead and ensure proper vendor oversight versus performing the work yourself is a hugely underestimated training need. These are two very different jobs. Once we opt to outsource a trial that had been done in-house, we need to release control (but not accountability) of the study to the CRO and let them do what they do best. Our job at that point is to provide oversight and set the strategic direction. We have to be able to demonstrate to regulators that we are maintaining control over the trial and ensuring patient safety, while also releasing some of the day-to-day activities and tasks to the CRO. That can be a very delicate balance." As noted earlier, a primary goal was maintaining treatments to patients. There were approximately 15 trials that had to be transitioned to the new CRO. While a lot was changing in the background, including contracts and the CRO representative at the investigative sites, there were no gaps in treatment for the patients, and most would not have known a change in CRO even took place. Do What You Do Best Although the biopharma business of Merck KGaA, Darmstadt, Germany has a large and competent legal team in house, it opted to have its new CRO partner do most of the contract work with sites due to the huge increase of workload during the transition. The pharma company provided QuintilesIMS with language it found acceptable and asked that new contracts be negotiated using that language. Allowing the chosen CRO to do things its own way was a new way of working. The two companies had to develop a plan for how to work together, which Curtiss notes was another important focus area. "We realized quickly that change management was key to the success. Leveraging the skills and expertise of both companies and bringing them together to create one team allowed us to really optimize the strategic intent of the part- nership. Change isn't easy, but everyone has made a concerted effort to make this collaboration a success for patients." LIFE SCIENCE EXCLUSIVE CONTENT Leaders By E. Miseta THE RISK & REWARDS OF A FULLY OUTSOURCED CLINICAL MODEL LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 8

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