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<br /> <br /> <br /> lin<br /> C ical Trials Insight <br /> 2018 Vol. 1<br /> Clinical trials 4.0<br /> The need to pack more digitalisation into drug development<br /> Work the cloud Brexit strategy<br /> The rise of remote data and What measures does the<br /> what it means for pharma sector have in place? <br /> Regulatory nCold chain nOutsourcing nPackaging<br /> <br /> <br /> Foreword<br /> On the web...<br /> Keep up with the latest developments in<br /> the pharmaceutical industry by visiting<br /> www.worldpharmaceuticals.net<br /> Clinical Trials Insight<br /> 2018 Vol. 1<br /> EDITORIAL<br /> Managing editor Phin Foster<br /> Chief sub-editor Thom Atkinson<br /> Sub-editors Jim Findlay, Alexandra Pollard<br /> Senior feature writer Greg Noone<br /> Feature writers Grace Allen,<br /> Neil Thompson, Andrea<a title="Clinical Trials Insight 2018 Vol. 1 page 1" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=1"> lin C ical Trials Insight </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 2" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=2"> </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 3" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=3"> Foreword On the web... Keep up with the latest d</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 4" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=4"> Contents In this issue 8 Cover s</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 5" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=5"> Contents Data protection is a troubling issue</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 6" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=6"> The intelligence > News SURGERY Clinical tri</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 7" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=7"> The intelligence > News TREATMENT Chinese fi</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 8" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=8"> Insight > Regulatory Trial separation In 2019</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 9" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=9"> Insight > Regulatory after all, from the immin</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 10" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=10"> Insight > Regulatory © Gordon Bell/Shutterstock.</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 11" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=11"> Healthcare View our latest range of reports at ww</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 12" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=12"> Dr. Barry Drees, Senior Partner Master Skills — P</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 13" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=13"> Insight > Regulatory Getting thewriting right Ge</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 14" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=14"> Insight > Regulatory Conformity assessment</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 15" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=15"> Insight > Regulatory Sweet harmony The increasing</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 16" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=16"> Insight > Regulatory © bakdc/Shutterstock.com T</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 17" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=17"> Insight > Regulatory TransCelerate's CEO, Dalv</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 18" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=18"> Insight > Trial design Rules of engagement How do</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 19" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=19"> Insight > Trial design T he tr</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 20" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=20"> Insight > Trial design </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 21" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=21"> Company insight > Trial design Enhancing clinic</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 22" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=22"> Insight > Data management Digital trailblazers In</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 23" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=23"> Insight > Data management potentially blocking</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 24" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=24"> Insight > Data management In a recent speech,</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 25" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=25"> Insight > Outsourcing With data in mind As</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 26" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=26"> Insight > Outsourcing </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 27" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=27"> Insight > Outsourcing extension of the sponsor</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 28" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=28"> </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 29" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=29"> Company insight > Outsourcing Have confidence i</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 30" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=30"> Company insight > Outsourcing The renting solut</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 31" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=31"> Company insight > Outsourcing Stage three: tria</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 32" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=32"> Company insight > Outsourcing Expertise for bio</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 33" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=33"> Company insight > Outsourcing proprietary web-b</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 34" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=34"> Insight > Comparators Sourcing on a global scal</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 35" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=35"> Insight > Comparators of maturity for conducti</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 36" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=36"> Insight > Comparators </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 37" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=37"> Your bridge to Germany's pharmaceutical market. </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 38" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=38"> Company insight > Comparators Make sourcing com</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 39" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=39"> Company insight > Comparators What backup plans</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 40" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=40"> MARKEN SHOULD BE YOUR FIRST CHOICE FOR YOUR PATIE</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 41" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=41"> Insight > Supply chain The legal matter Working w</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 42" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=42"> Insight > Supply chain Schedule 1, the st</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 43" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=43"> Insight > Supply chain </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 44" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=44"> Company insight > Supply chain Ensure a timely </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 45" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=45"> Company insight > Supply chain Multimode tr</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 46" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=46"> Insight > Cold chain & logistics Out in the co</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 47" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=47"> Insight > Cold chain & logistics distances wit</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 48" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=48"> Insight > Cold chain & logistics Different</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 49" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=49"> Company insight > Cold chain & logistics The id</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 50" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=50"> Company insight > Cold chain & logistics A proa</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 51" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=51"> Insight > Clinical trial supply Anti-cancer coll</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 52" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=52"> Insight > Clinical trial supply </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 53" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=53"> Insight > Clinical trial supply © Andriy Blokhin</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 54" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=54"> START STRONG, FINISH STRONGER DISCOVER CSM GLOBA</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 55" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=55"> Company insight > Clinical trial supply Transfo</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 56" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=56"> Special report > Cloud technology Silver linings</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 57" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=57"> Special report > Cloud technology difficult in</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 58" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=58"> Special report > Cloud technology </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 59" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=59"> Insight > Packaging Check the small print Tec</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 60" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=60"> Insight > Packaging Unl</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 61" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=61"> Insight > Packaging Faced with a surge of </a> <a title="Clinical Trials Insight 2018 Vol. 1 page 62" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=62"> Company insight > Packaging Simplifying clinica</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 63" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=63"> FOCUS ON YOUR STUDY... RxStudyCard™ BIN # 01</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 64" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=64"> Insight > Patient recruitment Play a role Emergin</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 65" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=65"> Insight > Patient recruitment duration – one y</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 66" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=66"> Insight > Patient recruitment Figure 4. Study d</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 67" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=67"> Dr. Barry Drees, Senior Partner Master Skills — P</a> <a title="Clinical Trials Insight 2018 Vol. 1 page 68" href="https://secure.viewer.zmags.com/publication/b47a8c6a?page=68"> global partner. scalable solutions. reliably supp</a>