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<br /> CLINICAL TRIALS<br /> YEARBOOK 2018<br /> Your Definitive Guide Through Testing Times 5th edition<br /> 2017 Lookback<br /> 21st Century Studies<br /> with 21st Century Tools<br /> – What is Developing to<br /> Increase Identification,<br /> Assessment and (Re)Use<br /> of Health Data?<br /> Nigel Hughes, Scientific Director,<br /> Real World Evidence, Janssen R&D<br /> A Transformative<br /> Landscape: Clinical<br /> Analytics Systems as the<br /> Future Tool for Clinical<br /> Trial Management<br /> Rachael DePasquale,<br /> Senior Manager, Resource and<br /> Analytics, Jazz Pharmaceuticals<br /> Baskets of Cancer<br /> Drugs – And an Umbrella<br /> Brandon Early,<br /> Oncology Drug Developer<br /> 2018 Outlook<br /> Is Your Organization<br /> GDPR Compliant?<br /> Jess Sohal, Executive Director,<br /> European Operations, UBC<br /> The Post-Brexit Era:<br /> Where is UK Clinical<br /> Research Headed in<br /> 2018 a<a title="Clinical Trials Yearbook 2018 page 1" href="https://secure.viewer.zmags.com/publication/57018028?page=1"> CLINICAL TRIALS YEARBOOK 2018 Your Definitive Guid</a> <a title="Clinical Trials Yearbook 2018 page 2" href="https://secure.viewer.zmags.com/publication/57018028?page=2"> Clinical Trial Supplies Competence at Aenova </a> <a title="Clinical Trials Yearbook 2018 page 3" href="https://secure.viewer.zmags.com/publication/57018028?page=3"> Editor’s note </a> <a title="Clinical Trials Yearbook 2018 page 4" href="https://secure.viewer.zmags.com/publication/57018028?page=4"> 2017 LOOKBACK 21st Century Studies with 21st</a> <a title="Clinical Trials Yearbook 2018 page 5" href="https://secure.viewer.zmags.com/publication/57018028?page=5">      Synteract_ClinicalTri</a> <a title="Clinical Trials Yearbook 2018 page 6" href="https://secure.viewer.zmags.com/publication/57018028?page=6"> 2017 LOOKBACK of industrial and academic exper</a> <a title="Clinical Trials Yearbook 2018 page 7" href="https://secure.viewer.zmags.com/publication/57018028?page=7"> and networks. It is planned to provide free wider</a> <a title="Clinical Trials Yearbook 2018 page 8" href="https://secure.viewer.zmags.com/publication/57018028?page=8"> 2017 LOOKBACK Peace at Last? – Final Guidanc</a> <a title="Clinical Trials Yearbook 2018 page 9" href="https://secure.viewer.zmags.com/publication/57018028?page=9"> needs a lot more guidance. A task force headed</a> <a title="Clinical Trials Yearbook 2018 page 10" href="https://secure.viewer.zmags.com/publication/57018028?page=10"> 2017 LOOKBACK allow confirmatory statements ab</a> <a title="Clinical Trials Yearbook 2018 page 11" href="https://secure.viewer.zmags.com/publication/57018028?page=11"> The new guidance will make the writing of lay sum</a> <a title="Clinical Trials Yearbook 2018 page 12" href="https://secure.viewer.zmags.com/publication/57018028?page=12"> 2017 LOOKBACK Advanced Therapies: Patient-Ce</a> <a title="Clinical Trials Yearbook 2018 page 13" href="https://secure.viewer.zmags.com/publication/57018028?page=13"> or material handler, can mean months of work wast</a> <a title="Clinical Trials Yearbook 2018 page 14" href="https://secure.viewer.zmags.com/publication/57018028?page=14"> Dr. Barry Drees, Senior Partner Warrior Skills — </a> <a title="Clinical Trials Yearbook 2018 page 15" href="https://secure.viewer.zmags.com/publication/57018028?page=15"> Are the foundations of the pharma supply chain ab</a> <a title="Clinical Trials Yearbook 2018 page 16" href="https://secure.viewer.zmags.com/publication/57018028?page=16"> 2017 LOOKBACK Protocol Feasibility in the EM</a> <a title="Clinical Trials Yearbook 2018 page 17" href="https://secure.viewer.zmags.com/publication/57018028?page=17"> 2017 LOOKBACK Study Sponsor Querying What-i</a> <a title="Clinical Trials Yearbook 2018 page 18" href="https://secure.viewer.zmags.com/publication/57018028?page=18"> 2017 LOOKBACK enroll patients which may or may</a> <a title="Clinical Trials Yearbook 2018 page 19" href="https://secure.viewer.zmags.com/publication/57018028?page=19"> 2017 LOOKBACK A Transformative Landscape: Cl</a> <a title="Clinical Trials Yearbook 2018 page 20" href="https://secure.viewer.zmags.com/publication/57018028?page=20"> 2017 LOOKBACK Typically now, a patient- base</a> <a title="Clinical Trials Yearbook 2018 page 21" href="https://secure.viewer.zmags.com/publication/57018028?page=21"> A well designed analytics system should take t</a> <a title="Clinical Trials Yearbook 2018 page 22" href="https://secure.viewer.zmags.com/publication/57018028?page=22"> 2017 LOOKBACK Precision Power Helps Drive th</a> <a title="Clinical Trials Yearbook 2018 page 23" href="https://secure.viewer.zmags.com/publication/57018028?page=23"> A Trusted Partner Expertise and Responsiveness in</a> <a title="Clinical Trials Yearbook 2018 page 24" href="https://secure.viewer.zmags.com/publication/57018028?page=24"> 2017 LOOKBACK This requires many of the proces</a> <a title="Clinical Trials Yearbook 2018 page 25" href="https://secure.viewer.zmags.com/publication/57018028?page=25"> 2017 LOOKBACK Baskets of Cancer Drugs – And a</a> <a title="Clinical Trials Yearbook 2018 page 26" href="https://secure.viewer.zmags.com/publication/57018028?page=26"> 2017 LOOKBACK </a> <a title="Clinical Trials Yearbook 2018 page 27" href="https://secure.viewer.zmags.com/publication/57018028?page=27"> many tumor types with a single protocol. Most of </a> <a title="Clinical Trials Yearbook 2018 page 28" href="https://secure.viewer.zmags.com/publication/57018028?page=28"> 2017 LOOKBACK A Steady Growth of Biosimilars</a> <a title="Clinical Trials Yearbook 2018 page 29" href="https://secure.viewer.zmags.com/publication/57018028?page=29"> 100 80 60 40 Figure 1: Biosimil</a> <a title="Clinical Trials Yearbook 2018 page 30" href="https://secure.viewer.zmags.com/publication/57018028?page=30"> 450 400 2031570 LOOKBACK 300 250 200 150 100 450 </a> <a title="Clinical Trials Yearbook 2018 page 31" href="https://secure.viewer.zmags.com/publication/57018028?page=31"> Biosimilar Clinical Trials by Therapy Area, 2007–</a> <a title="Clinical Trials Yearbook 2018 page 32" href="https://secure.viewer.zmags.com/publication/57018028?page=32"> 32 0 5 10 15 </a> <a title="Clinical Trials Yearbook 2018 page 33" href="https://secure.viewer.zmags.com/publication/57018028?page=33"> 2017 LOOKBACK Brexit and the Impact on Clini</a> <a title="Clinical Trials Yearbook 2018 page 34" href="https://secure.viewer.zmags.com/publication/57018028?page=34"> 2017 LOOKBACK </a> <a title="Clinical Trials Yearbook 2018 page 35" href="https://secure.viewer.zmags.com/publication/57018028?page=35"> than one Member State, and (c) accessing the EU p</a> <a title="Clinical Trials Yearbook 2018 page 36" href="https://secure.viewer.zmags.com/publication/57018028?page=36"> 2017 LOOKBACK Asia-Pacific Spotlight – Conduc</a> <a title="Clinical Trials Yearbook 2018 page 37" href="https://secure.viewer.zmags.com/publication/57018028?page=37"> A Full-Service Contract Research Organisation Put</a> <a title="Clinical Trials Yearbook 2018 page 38" href="https://secure.viewer.zmags.com/publication/57018028?page=38"> 2018 OUTLOOK Precision Medicine: Examining t</a> <a title="Clinical Trials Yearbook 2018 page 39" href="https://secure.viewer.zmags.com/publication/57018028?page=39"> An Added Complexity to the Drug Development Proce</a> <a title="Clinical Trials Yearbook 2018 page 40" href="https://secure.viewer.zmags.com/publication/57018028?page=40"> 2018 OUTLOOK Clinical trial monitoring has und</a> <a title="Clinical Trials Yearbook 2018 page 41" href="https://secure.viewer.zmags.com/publication/57018028?page=41"> 2018 OUTLOOK The Post-Brexit Era: Where is U</a> <a title="Clinical Trials Yearbook 2018 page 42" href="https://secure.viewer.zmags.com/publication/57018028?page=42"> 2018 OUTLOOK Now i</a> <a title="Clinical Trials Yearbook 2018 page 43" href="https://secure.viewer.zmags.com/publication/57018028?page=43"> • Marketing authorization holder: According t</a> <a title="Clinical Trials Yearbook 2018 page 44" href="https://secure.viewer.zmags.com/publication/57018028?page=44"> ADVERTORIAL Tracking Service for Monitoring </a> <a title="Clinical Trials Yearbook 2018 page 45" href="https://secure.viewer.zmags.com/publication/57018028?page=45"> recipient. This confirms that the shipment has re</a> <a title="Clinical Trials Yearbook 2018 page 46" href="https://secure.viewer.zmags.com/publication/57018028?page=46"> 2018 OUTLOOK The Evolving Data Management Ro</a> <a title="Clinical Trials Yearbook 2018 page 47" href="https://secure.viewer.zmags.com/publication/57018028?page=47"> focusing on what’s important and relevant in the </a> <a title="Clinical Trials Yearbook 2018 page 48" href="https://secure.viewer.zmags.com/publication/57018028?page=48"> 2018 OUTLOOK </a> <a title="Clinical Trials Yearbook 2018 page 49" href="https://secure.viewer.zmags.com/publication/57018028?page=49"> 2018 OUTLOOK </a> <a title="Clinical Trials Yearbook 2018 page 50" href="https://secure.viewer.zmags.com/publication/57018028?page=50"> 2018 OUTLOOK (Patient Clinical Trial System). </a> <a title="Clinical Trials Yearbook 2018 page 51" href="https://secure.viewer.zmags.com/publication/57018028?page=51"> Will Peter’s story soon become the norm for clini</a> <a title="Clinical Trials Yearbook 2018 page 52" href="https://secure.viewer.zmags.com/publication/57018028?page=52"> 2018 OUTLOOK Is Your Organization GDPR Compl</a> <a title="Clinical Trials Yearbook 2018 page 53" href="https://secure.viewer.zmags.com/publication/57018028?page=53"> embedded into any new process. HK: Will companie</a> <a title="Clinical Trials Yearbook 2018 page 54" href="https://secure.viewer.zmags.com/publication/57018028?page=54"> 2018 OUTLOOK Should the Pharmaceutical and B</a> <a title="Clinical Trials Yearbook 2018 page 55" href="https://secure.viewer.zmags.com/publication/57018028?page=55"> Harnessing the Power of Nature Nonetheless, the r</a> <a title="Clinical Trials Yearbook 2018 page 56" href="https://secure.viewer.zmags.com/publication/57018028?page=56"> 2018 OUTLOOK exendin-4, an active protein foun</a> <a title="Clinical Trials Yearbook 2018 page 57" href="https://secure.viewer.zmags.com/publication/57018028?page=57"> The leading clinical website for the biotech, pha</a> <a title="Clinical Trials Yearbook 2018 page 58" href="https://secure.viewer.zmags.com/publication/57018028?page=58"> 2018 OUTLOOK MDR 2017/745, the New Code of t</a> <a title="Clinical Trials Yearbook 2018 page 59" href="https://secure.viewer.zmags.com/publication/57018028?page=59"> Medical Device manufacturers have until the end o</a> <a title="Clinical Trials Yearbook 2018 page 60" href="https://secure.viewer.zmags.com/publication/57018028?page=60"> 2018 OUTLOOK When reviewing the safety risk </a> <a title="Clinical Trials Yearbook 2018 page 61" href="https://secure.viewer.zmags.com/publication/57018028?page=61"> 2018 OUTLOOK EU Clinical Trial Regulation: T</a> <a title="Clinical Trials Yearbook 2018 page 62" href="https://secure.viewer.zmags.com/publication/57018028?page=62"> 2018 OUTLOOK harmonization of requirements acr</a> <a title="Clinical Trials Yearbook 2018 page 63" href="https://secure.viewer.zmags.com/publication/57018028?page=63"> agree internally about the review responsibilitie</a> <a title="Clinical Trials Yearbook 2018 page 64" href="https://secure.viewer.zmags.com/publication/57018028?page=64"> 2018 OUTLOOK The Future of Investigator Broc</a> <a title="Clinical Trials Yearbook 2018 page 65" href="https://secure.viewer.zmags.com/publication/57018028?page=65"> 2018 OUTLOOK </a> <a title="Clinical Trials Yearbook 2018 page 66" href="https://secure.viewer.zmags.com/publication/57018028?page=66"> 2018 OUTLOOK regulation in the future, or if t</a> <a title="Clinical Trials Yearbook 2018 page 67" href="https://secure.viewer.zmags.com/publication/57018028?page=67"> 2018 OUTLOOK How These Five Industry Trends </a> <a title="Clinical Trials Yearbook 2018 page 68" href="https://secure.viewer.zmags.com/publication/57018028?page=68"> 2018 Events www.clinicaltrialsarena.com/events O</a> <a title="Clinical Trials Yearbook 2018 page 69" href="https://secure.viewer.zmags.com/publication/57018028?page=69"> The adoption of RBM presents a major challenge </a> <a title="Clinical Trials Yearbook 2018 page 70" href="https://secure.viewer.zmags.com/publication/57018028?page=70"> 2018 OUTLOOK Patient </a> <a title="Clinical Trials Yearbook 2018 page 71" href="https://secure.viewer.zmags.com/publication/57018028?page=71"> DIRECTORY OF SERVICES Directory of services Plea</a> <a title="Clinical Trials Yearbook 2018 page 72" href="https://secure.viewer.zmags.com/publication/57018028?page=72"> DIRECTORY OF SERVICES Novotech </a> <a title="Clinical Trials Yearbook 2018 page 73" href="https://secure.viewer.zmags.com/publication/57018028?page=73"> DIRECTORY OF SERVICES Interested in contributi</a> <a title="Clinical Trials Yearbook 2018 page 74" href="https://secure.viewer.zmags.com/publication/57018028?page=74"> FOCUS ON YOUR STUDY... RxStudyCard™ BIN # 012345 </a> <a title="Clinical Trials Yearbook 2018 page 75" href="https://secure.viewer.zmags.com/publication/57018028?page=75"> We Are UBC Dedicated to Real-World Evidence Solut</a>