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CRO Leadership Awards 2017

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EDITOR'S NOTE LSL LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2017 4 enough to even consider having that type of relationship with one CRO. They continue to try to make some form of the functional ser- vice provider model work for them. In fact, despite the rise in strategic partnerships, 79 percent of sponsors still tout working with four or more CRO partners. No model of outsourcing is perfect, and every variation of it will come with strengths and weaknesses that sponsors will be forced to navigate. The pros, including more timely, efficient, and cost-effective trials, are entic- ing. But the cons, including lack of cost sav- ings, staff changes, and providing proper oversight, will continue to keep operations personnel awake at night. Among sponsors, there has been a double-digit decline in sat- isfaction with access to high-quality person- nel. Furthermore, the number of sponsors noting their goals for cost savings are being met dropped from 48 percent in 2011 to 45 percent in 2016. Is there a solution? One new alliance com- prised of service providers thinks there is. The consortium, composed of five service providers including inSeption Group, FMD K&L, and Pyxa Solutions, believes the solu- tion starts with leveraging the strengths of each member organization across all func- tional areas of R&D. The promise is knowl- edgeable personnel, a seamless integration with one point of contact, and greater trans- parency over trials. Will this new model work? That remains to be seen. One thing is clear — challenges to outsourc- ing remain, and sponsors will continue to work at becoming fully operationalized with their partners. Change will remain an inte- gral component of every outsourcing rela- tionship, and we hope to see the day when all of the promises of strategic partnering come to fruition. In the meantime, Heraclitus would be proud to know his words continue to bear on the clinical world. hange is the only constant in life." That quote is attributed to Greek philosopher Heraclitus, but its theme still resonates today in many areas, including pharma. When it comes to clinical outsourcing, it certainly seems like the only thing that doesn't change is change. Last year when I prepared this annual CRO Supplement, our cover story featured Corsee Sanders of Roche. While most of the article centered on combining analytics with clinical operations, Sanders did note another major change underway at the company: Roche would focus on managing late-stage studies within the company, with few exceptions. Only site monitoring would be outsourced. Certainly some promises related to strate- gic outsourcing have thus far failed to come to fruition. One article in this issue from The Avoca Group focuses on sponsor survey results and notes several areas of dissatisfac- tion. But if you thought the era of outsourcing to strategic partners might be coming to an end, think again. In this issue you will read about the efforts of two companies, Takeda and EMD Serono, that each opted to form a strategic agreement with one CRO. All clinical trials will now be conducted by that single CRO partner. Some in the industry think strategic partner- ing is still a dream of only large pharma com- panies. But as you'll learn in this issue, 62 per- cent of sponsors now consider themselves to be in a strategic partnership, an increase of 27 percent over 2011. Yet many small to midsized companies will still tell you they are not large LIFE SCIENCE LEADER 5340 Fryling Rd., Suite 300 Erie, PA 16510-4672 Telephone: 814 897 7700 Fax: 814 899 5587 WWW.LIFESCIENCELEADER.COM CEO Jon Howland / Ext. 203 EDITORIAL DIRECTOR Dan Schell / Ext. 284 CHIEF EDITOR Rob Wright / Ext. 140 EXECUTIVE EDITOR Wayne Koberstein EDITORS Louis Garguilo Bob Marshall Ed Miseta Anna Rose Welch VP OF AUDIENCE DEVELOPMENT Michael Bennett STRATEGIC PARTNERSHIPS/BUSINESS DEV. Mike Barbalaci / Ext. 218 Tim Bretz / 724-940-7555 / Ext. 123 Cory Coleman / 724-940-7555 / Ext. 125 Scott Moren / Ext. 118 Shannon Primavere / Ext. 279 Perry Rearick / Ext. 263 Ray Sherman / Ext. 335 Tracy Tasker / Ext. 297 Derek Van Slyke / Ext. 217 Casey Weed / Ext. 219 DATA ANALYTICS Rick Miller Kevin Morey PRODUCTION DIRECTOR Lynn Netkowicz / Ext. 205 @ EdClinical CRO Partnering: The Only Constant Is Change E D M I S E T A Chief Editor, M AY 2 017 CR O S U PPLE M E NT " C

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