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<br /> CLINICAL TRIALS<br /> YEARBOOK 2013<br /> 1st edition / December 2013<br /> Results from new<br /> research on global<br /> CRA workload and<br /> utilization<br /> Improving efficiency<br /> and quality while<br /> reducing costs<br /> Kenneth Getz,<br /> Tufts University<br /> School of Medicine<br /> Leading global<br /> clinical research<br /> providers<br /> A look into some<br /> of the world’s highest-<br /> ranking service<br /> organizations<br /> Adam Dion,<br /> Global Data<br /> Sponsors from<br /> Mars, service<br /> providers<br /> from Venus<br /> Understanding the<br /> challenges while<br /> working with each<br /> other from a financial<br /> perspective<br /> Chris Chan,<br /> Onyx Pharmaceuticals<br /> <br /> Editor’s note<br /> To say that it’s been a challenging<br /> year for clinical trials and the<br /> biopharma industry would be <a title="Clinical Trials Yearbook 2013 page 1" href="http://viewer.zmags.com/publication/7fa6f829?page=1"> CLINICAL TRIALS YEARBOOK 2013 1st edition / Decem</a> <a title="Clinical Trials Yearbook 2013 page 2" href="http://viewer.zmags.com/publication/7fa6f829?page=2"> </a> <a title="Clinical Trials Yearbook 2013 page 3" href="http://viewer.zmags.com/publication/7fa6f829?page=3"> Editor’s note To s</a> <a title="Clinical Trials Yearbook 2013 page 4" href="http://viewer.zmags.com/publication/7fa6f829?page=4"> CLINICAL OUTSOURCING Is it possible to choose</a> <a title="Clinical Trials Yearbook 2013 page 5" href="http://viewer.zmags.com/publication/7fa6f829?page=5"> Measuring the benefit vs. risk of available outso</a> <a title="Clinical Trials Yearbook 2013 page 6" href="http://viewer.zmags.com/publication/7fa6f829?page=6"> CLINICAL OUTSOURCING work for </a> <a title="Clinical Trials Yearbook 2013 page 7" href="http://viewer.zmags.com/publication/7fa6f829?page=7"> CLINICAL OUTSOURCING Sponsors are from Mars, </a> <a title="Clinical Trials Yearbook 2013 page 8" href="http://viewer.zmags.com/publication/7fa6f829?page=8"> CLINICAL OUTSOURCING </a> <a title="Clinical Trials Yearbook 2013 page 9" href="http://viewer.zmags.com/publication/7fa6f829?page=9"> may shift personnel between different engagements</a> <a title="Clinical Trials Yearbook 2013 page 10" href="http://viewer.zmags.com/publication/7fa6f829?page=10"> CLINICAL OUTSOURCING taking the average of prior</a> <a title="Clinical Trials Yearbook 2013 page 11" href="http://viewer.zmags.com/publication/7fa6f829?page=11"> CLINICAL OUTSOURCING Working towards best pra</a> <a title="Clinical Trials Yearbook 2013 page 12" href="http://viewer.zmags.com/publication/7fa6f829?page=12"> CLINICAL OUTSOURCING </a> <a title="Clinical Trials Yearbook 2013 page 13" href="http://viewer.zmags.com/publication/7fa6f829?page=13"> The flip side of regularly checking in on pro</a> <a title="Clinical Trials Yearbook 2013 page 14" href="http://viewer.zmags.com/publication/7fa6f829?page=14"> CLINICAL OUTSOURCING clear lesson-to-be-learnt </a> <a title="Clinical Trials Yearbook 2013 page 15" href="http://viewer.zmags.com/publication/7fa6f829?page=15"> CLINICAL OUTSOURCING Outsourcing in medical d</a> <a title="Clinical Trials Yearbook 2013 page 16" href="http://viewer.zmags.com/publication/7fa6f829?page=16"> CLINICAL OUTSOURCING regions/locations, and inc</a> <a title="Clinical Trials Yearbook 2013 page 17" href="http://viewer.zmags.com/publication/7fa6f829?page=17"> CLINICAL OUTSOURCING capabilities and capa</a> <a title="Clinical Trials Yearbook 2013 page 18" href="http://viewer.zmags.com/publication/7fa6f829?page=18"> CLINICAL OUTSOURCING role. As Jim Buck, CEO of </a> <a title="Clinical Trials Yearbook 2013 page 19" href="http://viewer.zmags.com/publication/7fa6f829?page=19"> </a> <a title="Clinical Trials Yearbook 2013 page 20" href="http://viewer.zmags.com/publication/7fa6f829?page=20"> CLINICAL OUTSOURCING The role of the CRO in ef</a> <a title="Clinical Trials Yearbook 2013 page 21" href="http://viewer.zmags.com/publication/7fa6f829?page=21"> </a> <a title="Clinical Trials Yearbook 2013 page 22" href="http://viewer.zmags.com/publication/7fa6f829?page=22"> CLINICAL TRIAL SUPPLY Choosing a comparator so</a> <a title="Clinical Trials Yearbook 2013 page 23" href="http://viewer.zmags.com/publication/7fa6f829?page=23"> Ask 8 of the world’s top10 pharma companies about</a> <a title="Clinical Trials Yearbook 2013 page 24" href="http://viewer.zmags.com/publication/7fa6f829?page=24"> LLC Monitoring T Cell Immunity (CMI) for Clini</a> <a title="Clinical Trials Yearbook 2013 page 25" href="http://viewer.zmags.com/publication/7fa6f829?page=25"> CLINICAL TRIAL SUPPLY Unlocking the secret re</a> <a title="Clinical Trials Yearbook 2013 page 26" href="http://viewer.zmags.com/publication/7fa6f829?page=26"> CLINICAL TRIAL SUPPLY </a> <a title="Clinical Trials Yearbook 2013 page 27" href="http://viewer.zmags.com/publication/7fa6f829?page=27"> moment, only then would you know the magnitude of</a> <a title="Clinical Trials Yearbook 2013 page 28" href="http://viewer.zmags.com/publication/7fa6f829?page=28"> CLINICAL TRIAL SUPPLY </a> <a title="Clinical Trials Yearbook 2013 page 29" href="http://viewer.zmags.com/publication/7fa6f829?page=29"> ONE-STOP LABEL SOLUTIONS FOR CLINICAL TRIALS Ch</a> <a title="Clinical Trials Yearbook 2013 page 30" href="http://viewer.zmags.com/publication/7fa6f829?page=30"> CLINICAL TRIAL SUPPLY Improving the strategic </a> <a title="Clinical Trials Yearbook 2013 page 31" href="http://viewer.zmags.com/publication/7fa6f829?page=31"> </a> <a title="Clinical Trials Yearbook 2013 page 32" href="http://viewer.zmags.com/publication/7fa6f829?page=32"> CLINICAL TRIAL SUPPLY Establishing specific n</a> <a title="Clinical Trials Yearbook 2013 page 33" href="http://viewer.zmags.com/publication/7fa6f829?page=33"> daily for six months, pulse rate continuously for</a> <a title="Clinical Trials Yearbook 2013 page 34" href="http://viewer.zmags.com/publication/7fa6f829?page=34"> CLINICAL TRIAL SUPPLY For</a> <a title="Clinical Trials Yearbook 2013 page 35" href="http://viewer.zmags.com/publication/7fa6f829?page=35"> </a> <a title="Clinical Trials Yearbook 2013 page 36" href="http://viewer.zmags.com/publication/7fa6f829?page=36"> CLINICAL TRIAL SUPPLY Understanding the regula</a> <a title="Clinical Trials Yearbook 2013 page 37" href="http://viewer.zmags.com/publication/7fa6f829?page=37"> </a> <a title="Clinical Trials Yearbook 2013 page 38" href="http://viewer.zmags.com/publication/7fa6f829?page=38"> ArenaYearbook_112013_Layout 1 11/21/13 9:01 AM Pa</a> <a title="Clinical Trials Yearbook 2013 page 39" href="http://viewer.zmags.com/publication/7fa6f829?page=39"> CLINICAL TRIAL SUPPLY Recognising and maximis</a> <a title="Clinical Trials Yearbook 2013 page 40" href="http://viewer.zmags.com/publication/7fa6f829?page=40"> CLINICAL TRIAL SUPPLY </a> <a title="Clinical Trials Yearbook 2013 page 41" href="http://viewer.zmags.com/publication/7fa6f829?page=41"> CLINICAL TRIAL SUPPLY Effective planning for t</a> <a title="Clinical Trials Yearbook 2013 page 42" href="http://viewer.zmags.com/publication/7fa6f829?page=42"> CLINICAL TRIAL SUPPLY product will be at very s</a> <a title="Clinical Trials Yearbook 2013 page 43" href="http://viewer.zmags.com/publication/7fa6f829?page=43"> Your clinical trials are valuable C</a> <a title="Clinical Trials Yearbook 2013 page 44" href="http://viewer.zmags.com/publication/7fa6f829?page=44"> CLINICAL TRIAL SUPPLY Accessing the most activ</a> <a title="Clinical Trials Yearbook 2013 page 45" href="http://viewer.zmags.com/publication/7fa6f829?page=45"> </a> <a title="Clinical Trials Yearbook 2013 page 46" href="http://viewer.zmags.com/publication/7fa6f829?page=46"> CLINICAL OPERATIONS Leading global clinical r</a> <a title="Clinical Trials Yearbook 2013 page 47" href="http://viewer.zmags.com/publication/7fa6f829?page=47"> CLINICAL OPERATIONS 2012 vs 2011 Revenue (in </a> <a title="Clinical Trials Yearbook 2013 page 48" href="http://viewer.zmags.com/publication/7fa6f829?page=48"> CLINICAL OPERATIONS 12.1% revenue growth seen by </a> <a title="Clinical Trials Yearbook 2013 page 49" href="http://viewer.zmags.com/publication/7fa6f829?page=49"> 4 2012 Sales: $2.2B YoY Growth: 4.0% COVANCE Pr</a> <a title="Clinical Trials Yearbook 2013 page 50" href="http://viewer.zmags.com/publication/7fa6f829?page=50"> CLINICAL OPERATIONS 2 2012 Sales: $499.9M 2012 </a> <a title="Clinical Trials Yearbook 2013 page 51" href="http://viewer.zmags.com/publication/7fa6f829?page=51"> *Report description: GlobalData’s PharmaLeaders: </a> <a title="Clinical Trials Yearbook 2013 page 52" href="http://viewer.zmags.com/publication/7fa6f829?page=52"> CLINICAL OPERATIONS Safety reporting from clin</a> <a title="Clinical Trials Yearbook 2013 page 53" href="http://viewer.zmags.com/publication/7fa6f829?page=53"> </a> <a title="Clinical Trials Yearbook 2013 page 54" href="http://viewer.zmags.com/publication/7fa6f829?page=54"> CLINICAL OPERATIONS Utilizing in-home clinical</a> <a title="Clinical Trials Yearbook 2013 page 55" href="http://viewer.zmags.com/publication/7fa6f829?page=55"> Improve Recruitment and Retention by Mobilizing Y</a> <a title="Clinical Trials Yearbook 2013 page 56" href="http://viewer.zmags.com/publication/7fa6f829?page=56"> International Full-Service CRO  Clinical R&D </a> <a title="Clinical Trials Yearbook 2013 page 57" href="http://viewer.zmags.com/publication/7fa6f829?page=57"> CLINICAL OPERATIONS Reflections on how to suc</a> <a title="Clinical Trials Yearbook 2013 page 58" href="http://viewer.zmags.com/publication/7fa6f829?page=58"> CLINICAL OPERATIONS for a specific project. We</a> <a title="Clinical Trials Yearbook 2013 page 59" href="http://viewer.zmags.com/publication/7fa6f829?page=59"> understanding of the request and the preferences </a> <a title="Clinical Trials Yearbook 2013 page 60" href="http://viewer.zmags.com/publication/7fa6f829?page=60"> CLINICAL OPERATIONS information f</a> <a title="Clinical Trials Yearbook 2013 page 61" href="http://viewer.zmags.com/publication/7fa6f829?page=61"> </a> <a title="Clinical Trials Yearbook 2013 page 62" href="http://viewer.zmags.com/publication/7fa6f829?page=62"> CLINICAL OPERATIONS Advances in medicine are c</a> <a title="Clinical Trials Yearbook 2013 page 63" href="http://viewer.zmags.com/publication/7fa6f829?page=63"> The WIRB-Copernicus Group (WCG) is the world’s la</a> <a title="Clinical Trials Yearbook 2013 page 64" href="http://viewer.zmags.com/publication/7fa6f829?page=64"> CLINICAL OPERATIONS Baseline measures of glob</a> <a title="Clinical Trials Yearbook 2013 page 65" href="http://viewer.zmags.com/publication/7fa6f829?page=65"> Ninety-four percent of respondents were employed </a> <a title="Clinical Trials Yearbook 2013 page 66" href="http://viewer.zmags.com/publication/7fa6f829?page=66"> CLINICAL OPERATIONS feasibility questionnaires.</a> <a title="Clinical Trials Yearbook 2013 page 67" href="http://viewer.zmags.com/publication/7fa6f829?page=67"> Dr. Ebeling & Assoc. GmbH is a CSO with experienc</a> <a title="Clinical Trials Yearbook 2013 page 68" href="http://viewer.zmags.com/publication/7fa6f829?page=68"> CLINICAL OPERATIONS Finally, a path towards ec</a> <a title="Clinical Trials Yearbook 2013 page 69" href="http://viewer.zmags.com/publication/7fa6f829?page=69"> </a> <a title="Clinical Trials Yearbook 2013 page 70" href="http://viewer.zmags.com/publication/7fa6f829?page=70"> Dedicated Regulatory Contract Archive For the sec</a> <a title="Clinical Trials Yearbook 2013 page 71" href="http://viewer.zmags.com/publication/7fa6f829?page=71"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Patie</a> <a title="Clinical Trials Yearbook 2013 page 72" href="http://viewer.zmags.com/publication/7fa6f829?page=72"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT </a> <a title="Clinical Trials Yearbook 2013 page 73" href="http://viewer.zmags.com/publication/7fa6f829?page=73"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT area; </a> <a title="Clinical Trials Yearbook 2013 page 74" href="http://viewer.zmags.com/publication/7fa6f829?page=74"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT then t</a> <a title="Clinical Trials Yearbook 2013 page 75" href="http://viewer.zmags.com/publication/7fa6f829?page=75"> FINDERS & KEEPERS Finding eligible </a> <a title="Clinical Trials Yearbook 2013 page 76" href="http://viewer.zmags.com/publication/7fa6f829?page=76"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Keep c</a> <a title="Clinical Trials Yearbook 2013 page 77" href="http://viewer.zmags.com/publication/7fa6f829?page=77"> EDC|DM|IWRS Smarter EDC Studies. Lower Proj</a> <a title="Clinical Trials Yearbook 2013 page 78" href="http://viewer.zmags.com/publication/7fa6f829?page=78"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT From s</a> <a title="Clinical Trials Yearbook 2013 page 79" href="http://viewer.zmags.com/publication/7fa6f829?page=79"> Better trials begin with comprehensive solutions </a> <a title="Clinical Trials Yearbook 2013 page 80" href="http://viewer.zmags.com/publication/7fa6f829?page=80"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Asses</a> <a title="Clinical Trials Yearbook 2013 page 81" href="http://viewer.zmags.com/publication/7fa6f829?page=81"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT </a> <a title="Clinical Trials Yearbook 2013 page 82" href="http://viewer.zmags.com/publication/7fa6f829?page=82"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT </a> <a title="Clinical Trials Yearbook 2013 page 83" href="http://viewer.zmags.com/publication/7fa6f829?page=83"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT of dat</a> <a title="Clinical Trials Yearbook 2013 page 84" href="http://viewer.zmags.com/publication/7fa6f829?page=84"> Arena international clinical events 2014 Toronto</a> <a title="Clinical Trials Yearbook 2013 page 85" href="http://viewer.zmags.com/publication/7fa6f829?page=85"> Copenhagen, Denmark: - OCT Nordics Amsterdam, N</a> <a title="Clinical Trials Yearbook 2013 page 86" href="http://viewer.zmags.com/publication/7fa6f829?page=86"> Directory of services Please find below all servi</a> <a title="Clinical Trials Yearbook 2013 page 87" href="http://viewer.zmags.com/publication/7fa6f829?page=87"> ICTA (International Clinical Trials Association) </a> <a title="Clinical Trials Yearbook 2013 page 88" href="http://viewer.zmags.com/publication/7fa6f829?page=88"> </a>