Life Science Leader Magazine Supplements

CRO Supplement 2015

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EDITOR'S NOTE LSL LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 4 vice, I will tell my friends and family, "That is a quality establishment." The quality seems simple, immediate, and direct. But are their coolers at the right temperature? Are there rodents under the counters? Are employees washing their hands? I have no way of know- ing. Similarly, if a CRO completes your study on time, to your specifications, and meeting all regulatory requirements, they have cer- tainly served your needs well. Unfortunately, there could be quality issues looming that may very well sink your next study. How would you know? IDENTIFY, MEASURE, AND MONITOR So how do you identify quality in a CRO? How can you tell if they have a culture of quality or if it matches your own? Is there a way to measure and monitor it on an ongoing basis? These are questions that many clinical executives struggle with daily. In this edition of our annual CRO Supplement, we take a look at the issue of quality in clinical trials. Mike Howley, asso- ciate clinical professor at LeBow College of Business at Drexel University, discusses the research he has performed on measur- ing quality in trials (page 28). According to Howley, if you're measuring it, you're prob- ably doing it wrong. I hope you will find benefit in this article and the others we have produced for this supplement. In an industry where medical products are digested by or injected into human trial sub- jects, quality has to be on the minds of every- one. Or as Pirsig so eloquently put it: "My personal feeling is that this is how any fur- ther improvement of the world will be done: by individuals making quality decisions and that's all." l don't spend a lot of time thinking about quality. I doubt that most consumers do, even when purchasing pharmaceu- tical products. I have leg pain for which I take Ibuprofen almost daily. I also have a prescription medicine I take once a day. Even for these products, which could eas- ily affect my health and well-being, I do not stop to consider the manufacturer, country of origin, or most importantly, whether it was manufactured by a company with a focus on quality. Like most consumers, I just assume it [quality] is there. HOW DO YOU DEFINE QUALITY In the world of outsourced clinical trials, you are purchasing a service, not a product. But the result of a trial conducted with poor qual- ity could be even more disastrous: a blown study, an FDA rejection of your data, or worse … an injured patient. One of the first books I read on quality was Zen and the Art of Motorcycle Maintenance by philosopher and novelist Robert Pirsig. In the words of Pirsig, any philosophic explanation of quality is going to be both false and true precisely because it is a philosophic expla- nation. "What I mean (and everybody else means) by the word 'quality' cannot be broken down into subjects and predicates," he states. "This is not because quality is so mysterious but because quality is so simple, immediate, and direct." But is that always the case? If I eat a great meal in a great restaurant and get great ser- LIFE SCIENCE LEADER 5340 Fryling Rd., Suite 300 / Erie, PA 16510-4672 Telephone: 814 897 7700 / Fax: 814 899 4648 WWW.LIFESCIENCELEADER.COM SVP OF PUBLISHING/PRODUCT DEVELOPMENT Jon Howland / Ext. 203 VP OF CONTENT Ed Hess EDITORIAL DIRECTOR Dan Schell / Ext. 284 CHIEF EDITOR Rob Wright / Ext. 140 EXECUTIVE EDITORS Wayne Koberstein Louis Garguilo Ed Miseta Trisha Gladd Ken Congdon SENIOR DIRECTOR OF PUBLISHING Perry Rearick VP OF AUDIENCE DEVELOPMENT Michael Bennett PRODUCT DIRECTOR Jenell Skemp PROJECT MANAGER Megan Rainbow DIRECTOR, LIFE SCIENCE TRAINING INSTITUTE Bill Beyer PUBLISHER, CLINICAL & CONTRACT RESEARCH Sean Hoffman / 724 940 7557 / Ext. 165 PUBLISHER/BIOPHARM & LAB Shannon Primavere / Ext. 279 PUBLISHER/OUTSOURCING Cory Coleman / Ext. 108 ENGAGEMENT MANAGER Kevin Morey GROUP PUBLISHER/OUTSOURCING Ray Sherman / Ext. 335 BUSINESS DEVELOPMENT MANAGER Mike Barbalaci / Ext. 218 SR. ACCOUNT EXECUTIVE Scott Moren / Ext. 118 PRODUCTION DIRECTOR Lynn Netkowicz / Ext. 205 MANAGE SUBSCRIPTIONS 814 897 9000 / Ext. 315 Quality Is Never An Issue, Until It Becomes An Issue I M AY 2 015 CR O S U PPLE M E NT E D M I S E T A Executive Editor @ OutsourcedPharm

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