Life Science Leader Magazine Supplements

CRO Supplement 2015

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THE CRO LEADERSHIP AWARDS 2015 LIFESCIENCELEADER.COM 28 EVALUATING PERFORMANCE METRICS to was Michael Howley. He has authored or co-authored several papers on the topic and has appeared in Outsourced Pharma, Clinical Leader, and Applied Clinical Trials . Howley has a B.S. in biol- ogy, an MBA, a Ph.D. in business adminis- tration, and currently serves as associate clinical professor in the LeBow College of Business at Drexel University. His passion is measuring quality in trials, and if he is right, you are probably doing it all wrong. n fact, discussions about "culture of quality" are pervasive in the industry, and it's rare to attend a show or conference where this is not a popular topic of discussion. Where we may run into some disagreement is on how to best measure the level of quality in a clinical trial. A few months ago when I decided to produce an article on measuring quality in clinical trials, the first person I turned The way you measure the quality of a product is vastly different from how you would measure the quality of a service. I would certainly not measure the quality of a car I bought the same way I would measure the quality of a visit to my doctor. Unfortunately, many pharma companies may be guilty of making that mistake. IF YOU'RE MEASURING QUALITY, YOU'RE PROBABLY NOT DOING IT RIGHT Howley's research and experience in this space have led him to believe that there is a right and a wrong way to measure the quality sponsors are getting from a CRO. "Clinical trials are very different from manufacturing," says Howley. "In the pharma industry, most companies are manufacturers of a pill, but the clinical trial is a service. Assessing the quality of a service from a CRO must be done differ- ently than assessing the quality of your CMO. That is the message I am trying to get out to companies. They need to think about quality differently because what they are currently doing is not working." There is a science that has developed over the last 30 years on how to measure quality in a service industry. The meth- odology has been successfully applied in other industries, with great improve- ments in efficiency, productivity, and reduced costs. The process of developing measures to assess service quality in trials is well established. Still, Howley notes com- panies are free to develop their own. When developing an assessment, Howley recommends you: Define what you are measuring Decide what specific items will be measured (cost, productivity, reliability, etc.) Assess the validity and reliability of what you're measuring Link what you're measuring to the overall quality of the trial "I have found that pharma performs well on the first two steps," says Howley. By E. Miseta MEASURING QUALITY IN CLINICAL TRIALS: WHY YOU'RE PROBABLY DOING IT WRONG Measuring Quality In Clinical Trials: Why You're Probably Doing It Wrong E D M I S E T A Executive Editor @OutsourcedPharm Quality is undoubtedly one of the top concerns you will hear cited by pharma executives when it comes to clinical trials. When you talk to sponsors about what they look for in a service provider, quality is always at or near the top of the list. I

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