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<br /> CLINICAL TRIALS<br /> YEARBOOK 2016<br /> 3rd edition<br /> China: The Next Frontier?<br /> How to run successful trials<br /> with the Chinese population<br /> Kai Yew, Director, Clinical and Regulatory Affairs,<br /> Iridium Medical Technology<br /> Defining quality by<br /> design (QbD), risk-based<br /> monitoring (RBM) and<br /> centralized monitoring (CM)<br /> John Rodermund & Marcin Makowski,<br /> AstraZeneca<br /> Outsourcing practice<br /> a major barrier to<br /> realizing promise of<br /> strategic alliances<br /> Ken Getz, Director, Sponsored<br /> Research Programs,Tufts CSDD<br /> ESSENTIALS<br /> The Launch of<br /> The interactive community for clinical trials<br /> Arena International is delighted to launch ClinicalTrialsArena.com – the brand new online<br /> interactive community for clinical trials. Built upon our success of our clinical trial events<br /> over the past<a title="Clinical Trials Yearbook 2016 page 1" href="http://viewer.zmags.com/publication/01552163?page=1"> CLINICAL TRIALS YEARBOOK 2016 3rd edition Ch</a> <a title="Clinical Trials Yearbook 2016 page 2" href="http://viewer.zmags.com/publication/01552163?page=2"> ESSENTIALS The Launch of The interactiv</a> <a title="Clinical Trials Yearbook 2016 page 3" href="http://viewer.zmags.com/publication/01552163?page=3"> Editor's note With</a> <a title="Clinical Trials Yearbook 2016 page 4" href="http://viewer.zmags.com/publication/01552163?page=4"> CLINICAL OPERATIONS Maintaining flexibility </a> <a title="Clinical Trials Yearbook 2016 page 5" href="http://viewer.zmags.com/publication/01552163?page=5"> had no Marketing personnel until after we started</a> <a title="Clinical Trials Yearbook 2016 page 6" href="http://viewer.zmags.com/publication/01552163?page=6"> CLINICAL OPERATIONS showed evidence of cutting</a> <a title="Clinical Trials Yearbook 2016 page 7" href="http://viewer.zmags.com/publication/01552163?page=7"> </a> <a title="Clinical Trials Yearbook 2016 page 8" href="http://viewer.zmags.com/publication/01552163?page=8"> CLINICAL OPERATIONS New co-location strategy</a> <a title="Clinical Trials Yearbook 2016 page 9" href="http://viewer.zmags.com/publication/01552163?page=9"> not only what products it is currently making, bu</a> <a title="Clinical Trials Yearbook 2016 page 10" href="http://viewer.zmags.com/publication/01552163?page=10"> CLINICAL OPERATIONS Precision medicine: oppo</a> <a title="Clinical Trials Yearbook 2016 page 11" href="http://viewer.zmags.com/publication/01552163?page=11"> ON-DEMAND WEBINAR Precision Medi</a> <a title="Clinical Trials Yearbook 2016 page 12" href="http://viewer.zmags.com/publication/01552163?page=12"> CLINICAL OPERATIONS The Keys to Success: Dev</a> <a title="Clinical Trials Yearbook 2016 page 13" href="http://viewer.zmags.com/publication/01552163?page=13"> relevant articles „„Key Opinion Leader(KOL</a> <a title="Clinical Trials Yearbook 2016 page 14" href="http://viewer.zmags.com/publication/01552163?page=14"> CLINICAL OPERATIONS „„LinkedIn Page – link to </a> <a title="Clinical Trials Yearbook 2016 page 15" href="http://viewer.zmags.com/publication/01552163?page=15"> Working with you to create a healthier wor</a> <a title="Clinical Trials Yearbook 2016 page 16" href="http://viewer.zmags.com/publication/01552163?page=16"> CLINICAL OPERATIONS Oncology IITs – custom-m</a> <a title="Clinical Trials Yearbook 2016 page 17" href="http://viewer.zmags.com/publication/01552163?page=17"> trial than a careful balancing is performed betwe</a> <a title="Clinical Trials Yearbook 2016 page 18" href="http://viewer.zmags.com/publication/01552163?page=18"> CLINICAL OPERATIONS China: The Next Frontier</a> <a title="Clinical Trials Yearbook 2016 page 19" href="http://viewer.zmags.com/publication/01552163?page=19"> along with many trial sites within Chinese societ</a> <a title="Clinical Trials Yearbook 2016 page 20" href="http://viewer.zmags.com/publication/01552163?page=20"> CLINICAL OPERATIONS and doctors/researchers/me</a> <a title="Clinical Trials Yearbook 2016 page 21" href="http://viewer.zmags.com/publication/01552163?page=21"> CLINICAL TRIAL SUPPLY Investigating the biol</a> <a title="Clinical Trials Yearbook 2016 page 22" href="http://viewer.zmags.com/publication/01552163?page=22"> CLINICAL TRIAL SUPPLY were waiting for patient</a> <a title="Clinical Trials Yearbook 2016 page 23" href="http://viewer.zmags.com/publication/01552163?page=23"> A Trusted Partner Expertise and Care in Clinical </a> <a title="Clinical Trials Yearbook 2016 page 24" href="http://viewer.zmags.com/publication/01552163?page=24"> CLINICAL TRIAL SUPPLY Planning for success: </a> <a title="Clinical Trials Yearbook 2016 page 25" href="http://viewer.zmags.com/publication/01552163?page=25"> of subjects across those dose strengths, and anti</a> <a title="Clinical Trials Yearbook 2016 page 26" href="http://viewer.zmags.com/publication/01552163?page=26"> CLINICAL TRIAL SUPPLY Reference drug sourcin</a> <a title="Clinical Trials Yearbook 2016 page 27" href="http://viewer.zmags.com/publication/01552163?page=27"> For us, they’re not hard to find. Myoderm knows wh</a> <a title="Clinical Trials Yearbook 2016 page 28" href="http://viewer.zmags.com/publication/01552163?page=28"> CLINICAL TRIAL SUPPLY A journey through the </a> <a title="Clinical Trials Yearbook 2016 page 29" href="http://viewer.zmags.com/publication/01552163?page=29"> partners without the necessary knowledge of clini</a> <a title="Clinical Trials Yearbook 2016 page 30" href="http://viewer.zmags.com/publication/01552163?page=30"> fisherclinicalservices.com</a> <a title="Clinical Trials Yearbook 2016 page 31" href="http://viewer.zmags.com/publication/01552163?page=31"> CLINICAL TRIAL SUPPLY IT for agile clinical </a> <a title="Clinical Trials Yearbook 2016 page 32" href="http://viewer.zmags.com/publication/01552163?page=32"> CLINICAL TRIAL SUPPLY Also, the increasing num</a> <a title="Clinical Trials Yearbook 2016 page 33" href="http://viewer.zmags.com/publication/01552163?page=33"> Critical success factors • Alignment between Busi</a> <a title="Clinical Trials Yearbook 2016 page 34" href="http://viewer.zmags.com/publication/01552163?page=34"> CLINICAL TRIAL SUPPLY The evolution of tem</a> <a title="Clinical Trials Yearbook 2016 page 35" href="http://viewer.zmags.com/publication/01552163?page=35"> You command connections. The in-market resources</a> <a title="Clinical Trials Yearbook 2016 page 36" href="http://viewer.zmags.com/publication/01552163?page=36"> Setting NEW STANDARDS in high performance single </a> <a title="Clinical Trials Yearbook 2016 page 37" href="http://viewer.zmags.com/publication/01552163?page=37"> CLINICAL TRIAL SUPPLY Looking East: An explo</a> <a title="Clinical Trials Yearbook 2016 page 38" href="http://viewer.zmags.com/publication/01552163?page=38"> CLINICAL TRIAL SUPPLY sponsors currently trans</a> <a title="Clinical Trials Yearbook 2016 page 39" href="http://viewer.zmags.com/publication/01552163?page=39"> SOMETIMES THERE IS NO PLACE FOR MISTAKES </a> <a title="Clinical Trials Yearbook 2016 page 40" href="http://viewer.zmags.com/publication/01552163?page=40"> </a> <a title="Clinical Trials Yearbook 2016 page 41" href="http://viewer.zmags.com/publication/01552163?page=41"> CLINICAL OUTSOURCING Partnering with the rig</a> <a title="Clinical Trials Yearbook 2016 page 42" href="http://viewer.zmags.com/publication/01552163?page=42"> CLINICAL OUTSOURCING cars with two-wheel drive</a> <a title="Clinical Trials Yearbook 2016 page 43" href="http://viewer.zmags.com/publication/01552163?page=43"> they follow up on action items or missing</a> <a title="Clinical Trials Yearbook 2016 page 44" href="http://viewer.zmags.com/publication/01552163?page=44"> CLINICAL OUTSOURCING Immunotherapy clinical </a> <a title="Clinical Trials Yearbook 2016 page 45" href="http://viewer.zmags.com/publication/01552163?page=45"> Improving the lives of people battling cancer is </a> <a title="Clinical Trials Yearbook 2016 page 46" href="http://viewer.zmags.com/publication/01552163?page=46"> CLINICAL OUTSOURCING Best practices for stud</a> <a title="Clinical Trials Yearbook 2016 page 47" href="http://viewer.zmags.com/publication/01552163?page=47"> related progress and activity status. All stakeho</a> <a title="Clinical Trials Yearbook 2016 page 48" href="http://viewer.zmags.com/publication/01552163?page=48"> CLINICAL OUTSOURCING “Best Practice” Communica</a> <a title="Clinical Trials Yearbook 2016 page 49" href="http://viewer.zmags.com/publication/01552163?page=49"> Category Key elements Country status • Regul</a> <a title="Clinical Trials Yearbook 2016 page 50" href="http://viewer.zmags.com/publication/01552163?page=50"> </a> <a title="Clinical Trials Yearbook 2016 page 51" href="http://viewer.zmags.com/publication/01552163?page=51"> CLINICAL OUTSOURCING Outsourcing practice a </a> <a title="Clinical Trials Yearbook 2016 page 52" href="http://viewer.zmags.com/publication/01552163?page=52"> CLINICAL OUTSOURCING that requires collaborati</a> <a title="Clinical Trials Yearbook 2016 page 53" href="http://viewer.zmags.com/publication/01552163?page=53"> </a> <a title="Clinical Trials Yearbook 2016 page 54" href="http://viewer.zmags.com/publication/01552163?page=54"> “Responsiveness, flexibility and </a> <a title="Clinical Trials Yearbook 2016 page 55" href="http://viewer.zmags.com/publication/01552163?page=55"> CLINICAL OUTSOURCING One size does not fit a</a> <a title="Clinical Trials Yearbook 2016 page 56" href="http://viewer.zmags.com/publication/01552163?page=56"> CLINICAL OUTSOURCING Site selection and regula</a> <a title="Clinical Trials Yearbook 2016 page 57" href="http://viewer.zmags.com/publication/01552163?page=57"> CLINICAL OUTSOURCING No FDA form 1572 need</a> <a title="Clinical Trials Yearbook 2016 page 58" href="http://viewer.zmags.com/publication/01552163?page=58"> CLINICAL OUTSOURCING Large M&A deals drive p</a> <a title="Clinical Trials Yearbook 2016 page 59" href="http://viewer.zmags.com/publication/01552163?page=59"> Fig.1: Pharmaceutical sector, total deals and tot</a> <a title="Clinical Trials Yearbook 2016 page 60" href="http://viewer.zmags.com/publication/01552163?page=60"> CLINICAL OUTSOURCING Siegfried acquires pharma</a> <a title="Clinical Trials Yearbook 2016 page 61" href="http://viewer.zmags.com/publication/01552163?page=61"> CLINICAL OUTSOURCING Capital Raisings Equity o</a> <a title="Clinical Trials Yearbook 2016 page 62" href="http://viewer.zmags.com/publication/01552163?page=62"> </a> <a title="Clinical Trials Yearbook 2016 page 63" href="http://viewer.zmags.com/publication/01552163?page=63"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Defi</a> <a title="Clinical Trials Yearbook 2016 page 64" href="http://viewer.zmags.com/publication/01552163?page=64"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT th</a> <a title="Clinical Trials Yearbook 2016 page 65" href="http://viewer.zmags.com/publication/01552163?page=65"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Rand</a> <a title="Clinical Trials Yearbook 2016 page 66" href="http://viewer.zmags.com/publication/01552163?page=66"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT to the</a> <a title="Clinical Trials Yearbook 2016 page 67" href="http://viewer.zmags.com/publication/01552163?page=67"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT data f</a> <a title="Clinical Trials Yearbook 2016 page 68" href="http://viewer.zmags.com/publication/01552163?page=68"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Enco</a> <a title="Clinical Trials Yearbook 2016 page 69" href="http://viewer.zmags.com/publication/01552163?page=69"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT </a> <a title="Clinical Trials Yearbook 2016 page 70" href="http://viewer.zmags.com/publication/01552163?page=70"> Arena International Clinical Events 2016 Londo</a> <a title="Clinical Trials Yearbook 2016 page 71" href="http://viewer.zmags.com/publication/01552163?page=71"> Copenhagen, Denmark: - OCT Nordics - CTS Nordics </a> <a title="Clinical Trials Yearbook 2016 page 72" href="http://viewer.zmags.com/publication/01552163?page=72"> DIRECTORY OF SERVICES Directory of services Plea</a> <a title="Clinical Trials Yearbook 2016 page 73" href="http://viewer.zmags.com/publication/01552163?page=73"> Novella Celebrating our 15th year, Novella Clinic</a> <a title="Clinical Trials Yearbook 2016 page 74" href="http://viewer.zmags.com/publication/01552163?page=74"> DIRECTORY OF SERVICES Clinical Trial Logis</a> <a title="Clinical Trials Yearbook 2016 page 75" href="http://viewer.zmags.com/publication/01552163?page=75"> DIRECTORY OF SERVICES Myoderm Myo</a> <a title="Clinical Trials Yearbook 2016 page 76" href="http://viewer.zmags.com/publication/01552163?page=76"> Interested in contributing to the Clinical Trials</a>