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<br /> CLINICAL TRIALS<br /> YEARBOOK 2015<br /> 2nd edition<br /> Developing<br /> strategies<br /> for effective<br /> international trial<br /> management<br /> Jacqueline Lee, Director,<br /> Clinical Operations,<br /> Cytokinetics<br /> Thank you and<br /> goodbye to the<br /> booklet label<br /> Milad Kelada, Senior Director,<br /> Head of Supply Chain, Fibrogen<br /> Practical outsourcing<br /> and oversight:<br /> Designing in-depth<br /> deals incorporating<br /> all necessary aspects<br /> Marisa Bower, Director<br /> R&D Procurement,Teva<br /> Pharmaceuticals & Michael Cox,<br /> Senior Outsourcing Manager,<br /> Medimmune<br /> Exploring the<br /> transformative<br /> promise of patient<br /> centric R&D<br /> Ken Getz, Director<br /> of Sponsored Programs,<br /> Tufts CSDD<br /> Adaptive EDC at<br /> field, patient and<br /> study arm levels<br /> Terry Katz, Director,<br /> Global Data Management<br /> and Statistics,<br /> Merck An<a title="Clinical Trials Yearbook 2015 page 1" href="http://viewer.zmags.com/publication/37ab9aac?page=1"> CLINICAL TRIALS YEARBOOK 2015 2nd edition D</a> <a title="Clinical Trials Yearbook 2015 page 2" href="http://viewer.zmags.com/publication/37ab9aac?page=2"> </a> <a title="Clinical Trials Yearbook 2015 page 3" href="http://viewer.zmags.com/publication/37ab9aac?page=3"> Editor’s note After t</a> <a title="Clinical Trials Yearbook 2015 page 4" href="http://viewer.zmags.com/publication/37ab9aac?page=4"> CLINICAL OUTSOURCING Practical outsourcing an</a> <a title="Clinical Trials Yearbook 2015 page 5" href="http://viewer.zmags.com/publication/37ab9aac?page=5"> As functions answer these types of questions, the</a> <a title="Clinical Trials Yearbook 2015 page 6" href="http://viewer.zmags.com/publication/37ab9aac?page=6"> CLINICAL OUTSOURCING • Treat alignment as a sh</a> <a title="Clinical Trials Yearbook 2015 page 7" href="http://viewer.zmags.com/publication/37ab9aac?page=7"> Now, imagine expanding this from the internal bus</a> <a title="Clinical Trials Yearbook 2015 page 8" href="http://viewer.zmags.com/publication/37ab9aac?page=8"> CLINICAL OUTSOURCING Developing a patient-fri</a> <a title="Clinical Trials Yearbook 2015 page 9" href="http://viewer.zmags.com/publication/37ab9aac?page=9"> Improve Recruitment and Retention by Mobilizing Y</a> <a title="Clinical Trials Yearbook 2015 page 10" href="http://viewer.zmags.com/publication/37ab9aac?page=10"> CLINICAL OUTSOURCING Establishing the stronge</a> <a title="Clinical Trials Yearbook 2015 page 11" href="http://viewer.zmags.com/publication/37ab9aac?page=11"> CLINICAL OUTSOURCING Quality Evidence of the </a> <a title="Clinical Trials Yearbook 2015 page 12" href="http://viewer.zmags.com/publication/37ab9aac?page=12"> CLINICAL OUTSOURCING Timelines and price Time</a> <a title="Clinical Trials Yearbook 2015 page 13" href="http://viewer.zmags.com/publication/37ab9aac?page=13"> Contract Immune Monitoring Cell-Mediated Immunity</a> <a title="Clinical Trials Yearbook 2015 page 14" href="http://viewer.zmags.com/publication/37ab9aac?page=14"> CLINICAL OUTSOURCING To outsource or not to o</a> <a title="Clinical Trials Yearbook 2015 page 15" href="http://viewer.zmags.com/publication/37ab9aac?page=15"> CLINICAL OUTSOURCING Exhibit 1 </a> <a title="Clinical Trials Yearbook 2015 page 16" href="http://viewer.zmags.com/publication/37ab9aac?page=16"> CLINICAL OUTSOURCING Now, let’s ponder this fa</a> <a title="Clinical Trials Yearbook 2015 page 17" href="http://viewer.zmags.com/publication/37ab9aac?page=17"> way work is performed, but also to having more di</a> <a title="Clinical Trials Yearbook 2015 page 18" href="http://viewer.zmags.com/publication/37ab9aac?page=18"> </a> <a title="Clinical Trials Yearbook 2015 page 19" href="http://viewer.zmags.com/publication/37ab9aac?page=19"> CLINICAL OUTSOURCING Exploring strategies for</a> <a title="Clinical Trials Yearbook 2015 page 20" href="http://viewer.zmags.com/publication/37ab9aac?page=20"> CLINICAL OUTSOURCING very helpful! Ideally, it</a> <a title="Clinical Trials Yearbook 2015 page 21" href="http://viewer.zmags.com/publication/37ab9aac?page=21"> not currently exist in-house (i.e. IRT or investi</a> <a title="Clinical Trials Yearbook 2015 page 22" href="http://viewer.zmags.com/publication/37ab9aac?page=22"> International Full-Service CRO  Clinical R&D </a> <a title="Clinical Trials Yearbook 2015 page 23" href="http://viewer.zmags.com/publication/37ab9aac?page=23"> CLINICAL OUTSOURCING Exploring best practice </a> <a title="Clinical Trials Yearbook 2015 page 24" href="http://viewer.zmags.com/publication/37ab9aac?page=24"> CLINICAL OUTSOURCING From a sponsor point of v</a> <a title="Clinical Trials Yearbook 2015 page 25" href="http://viewer.zmags.com/publication/37ab9aac?page=25"> CLINICAL OUTSOURCING Ensuring enthusiasm for </a> <a title="Clinical Trials Yearbook 2015 page 26" href="http://viewer.zmags.com/publication/37ab9aac?page=26"> CLINICAL OUTSOURCING are a good fit for the st</a> <a title="Clinical Trials Yearbook 2015 page 27" href="http://viewer.zmags.com/publication/37ab9aac?page=27"> the vendor has access to the sites/investigators </a> <a title="Clinical Trials Yearbook 2015 page 28" href="http://viewer.zmags.com/publication/37ab9aac?page=28"> CLINICAL TRIAL SUPPLY Alleviating the pain of</a> <a title="Clinical Trials Yearbook 2015 page 29" href="http://viewer.zmags.com/publication/37ab9aac?page=29"> For us, they’re not hard to find. Myoderm knows wh</a> <a title="Clinical Trials Yearbook 2015 page 30" href="http://viewer.zmags.com/publication/37ab9aac?page=30"> CLINICAL TRIAL SUPPLY </a> <a title="Clinical Trials Yearbook 2015 page 31" href="http://viewer.zmags.com/publication/37ab9aac?page=31"> CLINICAL TRIAL SUPPLY Clinical supply chain c</a> <a title="Clinical Trials Yearbook 2015 page 32" href="http://viewer.zmags.com/publication/37ab9aac?page=32"> CLINICAL TRIAL SUPPLY management functions in </a> <a title="Clinical Trials Yearbook 2015 page 33" href="http://viewer.zmags.com/publication/37ab9aac?page=33"> This allowed substantial flexibility in securing </a> <a title="Clinical Trials Yearbook 2015 page 34" href="http://viewer.zmags.com/publication/37ab9aac?page=34"> CLINICAL TRIAL SUPPLY Reduce clinical trial c</a> <a title="Clinical Trials Yearbook 2015 page 35" href="http://viewer.zmags.com/publication/37ab9aac?page=35"> ON-DEMAND PACKAGING AND LABELING Shorten Timelin</a> <a title="Clinical Trials Yearbook 2015 page 36" href="http://viewer.zmags.com/publication/37ab9aac?page=36"> CLINICAL TRIAL SUPPLY Ensuring in-depth plann</a> <a title="Clinical Trials Yearbook 2015 page 37" href="http://viewer.zmags.com/publication/37ab9aac?page=37"> Getting your vendor involved at the earliest oppo</a> <a title="Clinical Trials Yearbook 2015 page 38" href="http://viewer.zmags.com/publication/37ab9aac?page=38"> CLINICAL TRIAL SUPPLY All these challenges and</a> <a title="Clinical Trials Yearbook 2015 page 39" href="http://viewer.zmags.com/publication/37ab9aac?page=39"> Durbin your trusted partner for clinical trials s</a> <a title="Clinical Trials Yearbook 2015 page 40" href="http://viewer.zmags.com/publication/37ab9aac?page=40"> CLINICAL TRIAL SUPPLY Meeting clinical trial </a> <a title="Clinical Trials Yearbook 2015 page 41" href="http://viewer.zmags.com/publication/37ab9aac?page=41"> CLINICAL TRIAL SUPPLY Your product is precious</a> <a title="Clinical Trials Yearbook 2015 page 42" href="http://viewer.zmags.com/publication/37ab9aac?page=42"> CLINICAL TRIAL SUPPLY Thank you and goodbye t</a> <a title="Clinical Trials Yearbook 2015 page 43" href="http://viewer.zmags.com/publication/37ab9aac?page=43"> concerning the risk the patient is exposed to in </a> <a title="Clinical Trials Yearbook 2015 page 44" href="http://viewer.zmags.com/publication/37ab9aac?page=44"> CLINICAL TRIAL SUPPLY sense, it would be split</a> <a title="Clinical Trials Yearbook 2015 page 45" href="http://viewer.zmags.com/publication/37ab9aac?page=45"> CLINICAL TRIAL SUPPLY Our Commitment To Deliver</a> <a title="Clinical Trials Yearbook 2015 page 46" href="http://viewer.zmags.com/publication/37ab9aac?page=46"> CLINICAL OPERATIONS Developing strategies for</a> <a title="Clinical Trials Yearbook 2015 page 47" href="http://viewer.zmags.com/publication/37ab9aac?page=47"> The best way to start building a relationship wit</a> <a title="Clinical Trials Yearbook 2015 page 48" href="http://viewer.zmags.com/publication/37ab9aac?page=48"> CLINICAL OPERATIONS Five steps to maximizing </a> <a title="Clinical Trials Yearbook 2015 page 49" href="http://viewer.zmags.com/publication/37ab9aac?page=49"> Rising above to provide a better clinical experie</a> <a title="Clinical Trials Yearbook 2015 page 50" href="http://viewer.zmags.com/publication/37ab9aac?page=50"> CLINICAL OPERATIONS Exploring the emerging ad</a> <a title="Clinical Trials Yearbook 2015 page 51" href="http://viewer.zmags.com/publication/37ab9aac?page=51"> SCRC collaboration follows the launch of Kun Tuo,</a> <a title="Clinical Trials Yearbook 2015 page 52" href="http://viewer.zmags.com/publication/37ab9aac?page=52"> CLINICAL OPERATIONS with liquid chromatography</a> <a title="Clinical Trials Yearbook 2015 page 53" href="http://viewer.zmags.com/publication/37ab9aac?page=53"> CLINICAL OPERATIONS Practical planning for th</a> <a title="Clinical Trials Yearbook 2015 page 54" href="http://viewer.zmags.com/publication/37ab9aac?page=54"> CLINICAL OPERATIONS strategy while accounting </a> <a title="Clinical Trials Yearbook 2015 page 55" href="http://viewer.zmags.com/publication/37ab9aac?page=55"> CLINICAL OPERATIONS regulatory meetings, and R</a> <a title="Clinical Trials Yearbook 2015 page 56" href="http://viewer.zmags.com/publication/37ab9aac?page=56"> CLINICAL OPERATIONS Implementing a risk-based</a> <a title="Clinical Trials Yearbook 2015 page 57" href="http://viewer.zmags.com/publication/37ab9aac?page=57"> CLINICAL OPERATIONS RISK BASED MONITORING Expert</a> <a title="Clinical Trials Yearbook 2015 page 58" href="http://viewer.zmags.com/publication/37ab9aac?page=58"> MediLingua BV Poortgebouw - Rijnsbur</a> <a title="Clinical Trials Yearbook 2015 page 59" href="http://viewer.zmags.com/publication/37ab9aac?page=59"> CLINICAL OPERATIONS The transformative promis</a> <a title="Clinical Trials Yearbook 2015 page 60" href="http://viewer.zmags.com/publication/37ab9aac?page=60"> CLINICAL OPERATIONS Clinical phase durations a</a> <a title="Clinical Trials Yearbook 2015 page 61" href="http://viewer.zmags.com/publication/37ab9aac?page=61"> Patient centered R&D seeks to engage patients and</a> <a title="Clinical Trials Yearbook 2015 page 62" href="http://viewer.zmags.com/publication/37ab9aac?page=62"> CLINICAL OPERATIONS </a> <a title="Clinical Trials Yearbook 2015 page 63" href="http://viewer.zmags.com/publication/37ab9aac?page=63"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Adapt</a> <a title="Clinical Trials Yearbook 2015 page 64" href="http://viewer.zmags.com/publication/37ab9aac?page=64"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Data M</a> <a title="Clinical Trials Yearbook 2015 page 65" href="http://viewer.zmags.com/publication/37ab9aac?page=65"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT plus t</a> <a title="Clinical Trials Yearbook 2015 page 66" href="http://viewer.zmags.com/publication/37ab9aac?page=66"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT when a</a> <a title="Clinical Trials Yearbook 2015 page 67" href="http://viewer.zmags.com/publication/37ab9aac?page=67"> IRT + eCOA Innovation + Experience + Quality e</a> <a title="Clinical Trials Yearbook 2015 page 68" href="http://viewer.zmags.com/publication/37ab9aac?page=68"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Adapt</a> <a title="Clinical Trials Yearbook 2015 page 69" href="http://viewer.zmags.com/publication/37ab9aac?page=69"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT When r</a> <a title="Clinical Trials Yearbook 2015 page 70" href="http://viewer.zmags.com/publication/37ab9aac?page=70"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT As a r</a> <a title="Clinical Trials Yearbook 2015 page 71" href="http://viewer.zmags.com/publication/37ab9aac?page=71"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Risk </a> <a title="Clinical Trials Yearbook 2015 page 72" href="http://viewer.zmags.com/publication/37ab9aac?page=72"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT The FD</a> <a title="Clinical Trials Yearbook 2015 page 73" href="http://viewer.zmags.com/publication/37ab9aac?page=73"> CLINICAL TECHNOLOGY AND DATA MANAGEMENT Howeve</a> <a title="Clinical Trials Yearbook 2015 page 74" href="http://viewer.zmags.com/publication/37ab9aac?page=74"> Arena International Clinical Events 2015 </a> <a title="Clinical Trials Yearbook 2015 page 75" href="http://viewer.zmags.com/publication/37ab9aac?page=75"> Copenhagen, Denmark: - OCT Nordics - CTS Nordics </a> <a title="Clinical Trials Yearbook 2015 page 76" href="http://viewer.zmags.com/publication/37ab9aac?page=76"> DIRECTORY OF SERVICES Directory of services </a> <a title="Clinical Trials Yearbook 2015 page 77" href="http://viewer.zmags.com/publication/37ab9aac?page=77"> ICTA is an international CRO with 30 years of exp</a> <a title="Clinical Trials Yearbook 2015 page 78" href="http://viewer.zmags.com/publication/37ab9aac?page=78"> DIRECTORY OF SERVICES Language services </a> <a title="Clinical Trials Yearbook 2015 page 79" href="http://viewer.zmags.com/publication/37ab9aac?page=79"> BAP Pharma is a specialist supplier of comparator</a> <a title="Clinical Trials Yearbook 2015 page 80" href="http://viewer.zmags.com/publication/37ab9aac?page=80"> DIRECTORY OF SERVICES Since 1997, CSM h</a> <a title="Clinical Trials Yearbook 2015 page 81" href="http://viewer.zmags.com/publication/37ab9aac?page=81"> Sensitech Inc. enables global leaders in the life</a> <a title="Clinical Trials Yearbook 2015 page 82" href="http://viewer.zmags.com/publication/37ab9aac?page=82"> Interested in contributing to the Clinical Trials</a>