Life Science Leader Magazine Supplements

CRO Guide 2016

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By E. Miseta ROCHE COMBINES ANALYTICS & CLINICAL OPERATIONS FOR BETTER FEASIBILITY PLANS LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 8 ROCHE leaders with our investigators, being local experts in the therapeutic areas, having close oversight of study quality, and having information from these trials in a standard, comprehensive, and accessible format to make better informed decisions and explorations," Sanders explains. She cites a few considerations for her team's reasoning. "Global CROs are professionals with expertise and proven ability to execute clinical trials and the flexibility to absorb the large shifts in resource demands inherent in Phase 3 programs. There are many instances when leveraging global CROs is the best, or sometimes the only, way to execute trials. The direction we are taking was driven primarily by our desire to have direct site relationships and in-depth understanding of the environment at the country level to inform the design and planning of trial execution, especially in areas new to us. An equally important driver is the need to have a consistent model to enable rapid and easy data capture and access to clinical trial infor- mation across the hundreds of studies and sites in a way that is meaningful." When asked about the concept of Big Pharma buying a large CRO, Sanders notes that although this is an interesting evolution of the pharma-CRO relation- ship, Roche late-stage clinical operations has not considered this approach. Sharing Success Stories With Others Sanders believes there are many things the industry can do better regarding clinical trials, and she thinks getting companies to work together on solu- tions will speed their development and implementation. For that reason, she heads up external collaboration initia- tives for Roche. She also sits on the board of directors at TransCelerate Biopharma Inc. as the vice chair. "I always have felt that cooperation is key to success in pharma," she states. "There are areas in which we all compete, but there are areas where likelihood of delivering on their commitments to patient enrollment? If Germany drops out of a study, how will it affect our model? If we add more sites to a study, what is the likelihood that the timelines will move up by a quarter? How is Roche clinical operations performing relative to industry peers? Given our potential portfolio two to three years from now, what operational factors should we start preparing to ensure high likelihood of execution success? "We need this capability to conduct pre- dictive modeling within the system," she adds. "We need to have the ability to put science, analytics, and sophistication into our feasibility and oversight activities, which will improve the quality of the answers we get. We believe this is a big game changer when it comes to performing clinical trials because to get this capability, we had to deal with many systems. When you have multiple systems in place, things can get very complex if you are not able to 'discipline' the systems to match your needs in the simplest possible way." Does Clinical Trial Intelligence Belong With You Or Your CRO? With the value of data increasing every day, many pharma companies are faced with a tough decision: Should we have that intelligence in-house or allow it to reside with CRO partners? On this point, Sanders and her leadership team thought long and hard before coming to a decision. Ultimately, Roche will focus on managing its late-stage studies within the company, with few excep- tions, and outsourcing only site monitoring. "The goal is to have Roche staff around the world working when I find the data I want, I also should have a very high level of confidence in it." Several different vendors that have information layer technologies are cur- rently being evaluated, and Sanders is also looking at leveraging technologies already in place at Roche. A vendor deci- sion is expected to be made by the end of the second quarter of 2016. She notes there are numerous challenges, including the fact that many of these technologies are still relatively new. Another is getting all internal stakeholders on board. She is taking a slow and measured approach to ensure buy-in from all job functions that will be impacted by the changes. In the meantime, data is being broken up into "core data packages" so as to better move them into the new architecture being built. "This has made it easier to get alignment and has enabled us to test structures with smaller amounts of data and then apply the lessons learned as we move on to the next package," she says. While the new information layer will not eliminate all of the different systems already in place, it will allow the company to share data more easily and seamlessly across systems and analyze that data via reports and dashboards. According to Sanders, the systems are transactional tools; they facilitate the input or extraction of data, but the information layer will hold the information and remain the single source of truth. The program already seems to be simpli- fying the jobs of many in her organization. Roche conducts an incredible number of programs collecting large amounts of trial data. The teams should be able to use this data, with matching analytics and benchmark information, to assess how long it will take to complete a study under different assumptions — and to determine if they can do better. When the fully implemented informa- tion layer is in place, teams and senior leaders like Sanders will have the ability to interrogate the data through queries. Examples of these queries include: Which countries/sites have the highest

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