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<br /> 2019<br /> 3rd Edition<br /> Clinical Trial<br /> Supply Handbook<br /> The go-to-guide for professionals in the global clinical supply space<br /> www.clinicaltrialsarena.com<br /> We provide world-leading access to<br /> Branded Medicines,<br /> Generics and Biosimilars<br /> Comparators and<br /> Reference Listed Drugs<br /> Science-Driven Sourcing<br /> Optimal Bespoke Strategies<br /> UK GERMANY USA<br /> +44 (0)20 3954 0518<br /> info@clinicalservices.eu<br /> www.clinicalservices.eu<br /> Clinical Trial Supply<br /> Handbook 2019<br /> Editor: Henry Kerali<br /> Designers: Henrik Williams,<br /> Scott Thompson<br /> Marketing Manager: Hannah Leigh<br /> Marketing Assistant: Harry Parsons<br /> For Handbook Enquiries<br /> please contact:<br /> Masood Jon<br /> T: +44 207 936 6611<br /> E: Masood.Jon@Arena-International.com<br /> Clinical Trial Supply Handbook (Print)<br /> ISSN 2399-645<a title="Clincal Trials Supply Handbook 2019 page 1" href="https://secure.viewer.zmags.com/publication/756d7a27?page=1"> 2019 3rd Edition Clinical Trial Supp</a> <a title="Clincal Trials Supply Handbook 2019 page 2" href="https://secure.viewer.zmags.com/publication/756d7a27?page=2"> We provide world-leading access to </a> <a title="Clincal Trials Supply Handbook 2019 page 3" href="https://secure.viewer.zmags.com/publication/756d7a27?page=3"> Clinical Trial Supply Handbook 2019 Editor: Henr</a> <a title="Clincal Trials Supply Handbook 2019 page 4" href="https://secure.viewer.zmags.com/publication/756d7a27?page=4"> CONTENTS Contents Clinical Supply Operations </a> <a title="Clincal Trials Supply Handbook 2019 page 5" href="https://secure.viewer.zmags.com/publication/756d7a27?page=5"> The HIGHEST QUALITY CLINICAL </a> <a title="Clincal Trials Supply Handbook 2019 page 6" href="https://secure.viewer.zmags.com/publication/756d7a27?page=6"> CLINICAL SUPPLY OPERATIONS Integrating New Ass</a> <a title="Clincal Trials Supply Handbook 2019 page 7" href="https://secure.viewer.zmags.com/publication/756d7a27?page=7"> Understanding the Driving Elements of Supply and </a> <a title="Clincal Trials Supply Handbook 2019 page 8" href="https://secure.viewer.zmags.com/publication/756d7a27?page=8"> CLINICAL SUPPLY OPERATIONS </a> <a title="Clincal Trials Supply Handbook 2019 page 9" href="https://secure.viewer.zmags.com/publication/756d7a27?page=9"> nnManufacturing will need to be scheduled. Su</a> <a title="Clincal Trials Supply Handbook 2019 page 10" href="https://secure.viewer.zmags.com/publication/756d7a27?page=10"> CLINICAL SUPPLY OPERATIONS </a> <a title="Clincal Trials Supply Handbook 2019 page 11" href="https://secure.viewer.zmags.com/publication/756d7a27?page=11"> This can be a significant struggle if you are w</a> <a title="Clincal Trials Supply Handbook 2019 page 12" href="https://secure.viewer.zmags.com/publication/756d7a27?page=12"> For</a> <a title="Clincal Trials Supply Handbook 2019 page 13" href="https://secure.viewer.zmags.com/publication/756d7a27?page=13"> CLINICAL SUPPLY OPERATIONS </a> <a title="Clincal Trials Supply Handbook 2019 page 14" href="https://secure.viewer.zmags.com/publication/756d7a27?page=14"> CLINICAL SUPPLY OPERATIONS the good and bad us</a> <a title="Clincal Trials Supply Handbook 2019 page 15" href="https://secure.viewer.zmags.com/publication/756d7a27?page=15"> CLINICAL SUPPLY OPERATIONS Risk Assessmen</a> <a title="Clincal Trials Supply Handbook 2019 page 16" href="https://secure.viewer.zmags.com/publication/756d7a27?page=16"> A Trusted Partner Expertise and Responsiveness in</a> <a title="Clincal Trials Supply Handbook 2019 page 17" href="https://secure.viewer.zmags.com/publication/756d7a27?page=17"> Temperature and Time Considerations are critical </a> <a title="Clincal Trials Supply Handbook 2019 page 18" href="https://secure.viewer.zmags.com/publication/756d7a27?page=18"> CLINICAL SUPPLY OPERATIONS </a> <a title="Clincal Trials Supply Handbook 2019 page 19" href="https://secure.viewer.zmags.com/publication/756d7a27?page=19"> the interface is new. Therefore, expectation</a> <a title="Clincal Trials Supply Handbook 2019 page 20" href="https://secure.viewer.zmags.com/publication/756d7a27?page=20"> CLINICAL SUPPLY OPERATIONS S</a> <a title="Clincal Trials Supply Handbook 2019 page 21" href="https://secure.viewer.zmags.com/publication/756d7a27?page=21"> countries of interest, the sponsor must validate </a> <a title="Clincal Trials Supply Handbook 2019 page 22" href="https://secure.viewer.zmags.com/publication/756d7a27?page=22"> CLINICAL SUPPLY OPERATIONS nnConsistency of dr</a> <a title="Clincal Trials Supply Handbook 2019 page 23" href="https://secure.viewer.zmags.com/publication/756d7a27?page=23"> CLINICAL SUPPLY OPERATIONS </a> <a title="Clincal Trials Supply Handbook 2019 page 24" href="https://secure.viewer.zmags.com/publication/756d7a27?page=24"> CLINICAL SUPPLY OPERATIONS Strategic Comparato</a> <a title="Clincal Trials Supply Handbook 2019 page 25" href="https://secure.viewer.zmags.com/publication/756d7a27?page=25"> We deliver innovative and agile compa</a> <a title="Clincal Trials Supply Handbook 2019 page 26" href="https://secure.viewer.zmags.com/publication/756d7a27?page=26"> CLINICAL SUPPLY OPERATIONS an emergency rescue</a> <a title="Clincal Trials Supply Handbook 2019 page 27" href="https://secure.viewer.zmags.com/publication/756d7a27?page=27"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 28" href="https://secure.viewer.zmags.com/publication/756d7a27?page=28"> TEMPERATURE MAINTENANCE therapies. Gene therap</a> <a title="Clincal Trials Supply Handbook 2019 page 29" href="https://secure.viewer.zmags.com/publication/756d7a27?page=29"> (i.e. peak sales), starts its decline and eventua</a> <a title="Clincal Trials Supply Handbook 2019 page 30" href="https://secure.viewer.zmags.com/publication/756d7a27?page=30"> TEMPERATURE MAINTENANCE EARLY MIDDLE LATE Pre-C</a> <a title="Clincal Trials Supply Handbook 2019 page 31" href="https://secure.viewer.zmags.com/publication/756d7a27?page=31"> TEMPERATURE MAINTENANCE Patient Demand Prevale</a> <a title="Clincal Trials Supply Handbook 2019 page 32" href="https://secure.viewer.zmags.com/publication/756d7a27?page=32"> TEMPERATURE MAINTENANCE Hot on the Trail of Re</a> <a title="Clincal Trials Supply Handbook 2019 page 33" href="https://secure.viewer.zmags.com/publication/756d7a27?page=33"> </a> <a title="Clincal Trials Supply Handbook 2019 page 34" href="https://secure.viewer.zmags.com/publication/756d7a27?page=34"> TEMPERATURE MAINTENANCE humidity within the co</a> <a title="Clincal Trials Supply Handbook 2019 page 35" href="https://secure.viewer.zmags.com/publication/756d7a27?page=35"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 36" href="https://secure.viewer.zmags.com/publication/756d7a27?page=36"> TEMPERATURE MAINTENANCE department, involving </a> <a title="Clincal Trials Supply Handbook 2019 page 37" href="https://secure.viewer.zmags.com/publication/756d7a27?page=37"> was a key stage before determining how systems co</a> <a title="Clincal Trials Supply Handbook 2019 page 38" href="https://secure.viewer.zmags.com/publication/756d7a27?page=38"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 39" href="https://secure.viewer.zmags.com/publication/756d7a27?page=39"> TEMPERATURE MAINTENANCE Store Transport Store T</a> <a title="Clincal Trials Supply Handbook 2019 page 40" href="https://secure.viewer.zmags.com/publication/756d7a27?page=40"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 41" href="https://secure.viewer.zmags.com/publication/756d7a27?page=41"> Implementing the Principles In implementing these</a> <a title="Clincal Trials Supply Handbook 2019 page 42" href="https://secure.viewer.zmags.com/publication/756d7a27?page=42"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 43" href="https://secure.viewer.zmags.com/publication/756d7a27?page=43"> northern Minnesota in the winter. They went on to</a> <a title="Clincal Trials Supply Handbook 2019 page 44" href="https://secure.viewer.zmags.com/publication/756d7a27?page=44"> TEMPERATURE MAINTENANCE Expert Committee. The </a> <a title="Clincal Trials Supply Handbook 2019 page 45" href="https://secure.viewer.zmags.com/publication/756d7a27?page=45"> should also be in place for investigating and han</a> <a title="Clincal Trials Supply Handbook 2019 page 46" href="https://secure.viewer.zmags.com/publication/756d7a27?page=46"> TEMPERATURE MAINTENANCE </a> <a title="Clincal Trials Supply Handbook 2019 page 47" href="https://secure.viewer.zmags.com/publication/756d7a27?page=47"> the expert comparator supplier... Qualit</a> <a title="Clincal Trials Supply Handbook 2019 page 48" href="https://secure.viewer.zmags.com/publication/756d7a27?page=48"> TEMPERATURE MAINTENANCE for different solutions</a> <a title="Clincal Trials Supply Handbook 2019 page 49" href="https://secure.viewer.zmags.com/publication/756d7a27?page=49"> communicating device is the best choice to ensure</a> <a title="Clincal Trials Supply Handbook 2019 page 50" href="https://secure.viewer.zmags.com/publication/756d7a27?page=50"> CLINICAL MANUFACTURING </a> <a title="Clincal Trials Supply Handbook 2019 page 51" href="https://secure.viewer.zmags.com/publication/756d7a27?page=51"> CLINICAL MANUFACTURING 40% 30% 20% 10</a> <a title="Clincal Trials Supply Handbook 2019 page 52" href="https://secure.viewer.zmags.com/publication/756d7a27?page=52"> CLINICAL MANUFACTURING F</a> <a title="Clincal Trials Supply Handbook 2019 page 53" href="https://secure.viewer.zmags.com/publication/756d7a27?page=53"> guidelines, the agency will not seek regulatory a</a> <a title="Clincal Trials Supply Handbook 2019 page 54" href="https://secure.viewer.zmags.com/publication/756d7a27?page=54"> CLINICAL MANUFACTURING E</a> <a title="Clincal Trials Supply Handbook 2019 page 55" href="https://secure.viewer.zmags.com/publication/756d7a27?page=55"> CLINICAL MANUFACTURING Study Parameter </a> <a title="Clincal Trials Supply Handbook 2019 page 56" href="https://secure.viewer.zmags.com/publication/756d7a27?page=56"> CLINICAL MANUFACTURING To </a> <a title="Clincal Trials Supply Handbook 2019 page 57" href="https://secure.viewer.zmags.com/publication/756d7a27?page=57"> CLINICAL MANUFACTURING Preclinical </a> <a title="Clincal Trials Supply Handbook 2019 page 58" href="https://secure.viewer.zmags.com/publication/756d7a27?page=58"> CLINICAL MANUFACTURING Manufac</a> <a title="Clincal Trials Supply Handbook 2019 page 59" href="https://secure.viewer.zmags.com/publication/756d7a27?page=59"> JOIN OUR CLINICAL TRIAL SUPPLY COMMUNITY T</a> <a title="Clincal Trials Supply Handbook 2019 page 60" href="https://secure.viewer.zmags.com/publication/756d7a27?page=60"> CLINICAL MANUFACTURING overshadowed by limited</a> <a title="Clincal Trials Supply Handbook 2019 page 61" href="https://secure.viewer.zmags.com/publication/756d7a27?page=61"> CLINICAL MANUFACTURING </a> <a title="Clincal Trials Supply Handbook 2019 page 62" href="https://secure.viewer.zmags.com/publication/756d7a27?page=62"> CLINICAL MANUFACTURING Raw Materials/ Suppliers</a> <a title="Clincal Trials Supply Handbook 2019 page 63" href="https://secure.viewer.zmags.com/publication/756d7a27?page=63"> CLINICAL MANUFACTURING Reference Standard/Speci</a> <a title="Clincal Trials Supply Handbook 2019 page 64" href="https://secure.viewer.zmags.com/publication/756d7a27?page=64"> CLINICAL MANUFACTURING  Drug Substance Consi</a> <a title="Clincal Trials Supply Handbook 2019 page 65" href="https://secure.viewer.zmags.com/publication/756d7a27?page=65"> CLINICAL MANUFACTURING </a> <a title="Clincal Trials Supply Handbook 2019 page 66" href="https://secure.viewer.zmags.com/publication/756d7a27?page=66"> Clinical Trials Addressing the key challenges in </a> <a title="Clincal Trials Supply Handbook 2019 page 67" href="https://secure.viewer.zmags.com/publication/756d7a27?page=67"> CLINICAL SUPPLY TECHNOLOGY Smarter Clinical Tr</a> <a title="Clincal Trials Supply Handbook 2019 page 68" href="https://secure.viewer.zmags.com/publication/756d7a27?page=68"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 69" href="https://secure.viewer.zmags.com/publication/756d7a27?page=69"> trials to create a more patient-centric clinical </a> <a title="Clincal Trials Supply Handbook 2019 page 70" href="https://secure.viewer.zmags.com/publication/756d7a27?page=70"> CLINICAL SUPPLY TECHNOLOGY A</a> <a title="Clincal Trials Supply Handbook 2019 page 71" href="https://secure.viewer.zmags.com/publication/756d7a27?page=71"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 72" href="https://secure.viewer.zmags.com/publication/756d7a27?page=72"> </a> <a title="Clincal Trials Supply Handbook 2019 page 73" href="https://secure.viewer.zmags.com/publication/756d7a27?page=73">  Reduce costs and risks Reach the Recruitment </a> <a title="Clincal Trials Supply Handbook 2019 page 74" href="https://secure.viewer.zmags.com/publication/756d7a27?page=74"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 75" href="https://secure.viewer.zmags.com/publication/756d7a27?page=75"> for their products on the horizon. That said, if </a> <a title="Clincal Trials Supply Handbook 2019 page 76" href="https://secure.viewer.zmags.com/publication/756d7a27?page=76"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 77" href="https://secure.viewer.zmags.com/publication/756d7a27?page=77"> to achieve reduction of manual oversight. IRT can</a> <a title="Clincal Trials Supply Handbook 2019 page 78" href="https://secure.viewer.zmags.com/publication/756d7a27?page=78"> </a> <a title="Clincal Trials Supply Handbook 2019 page 79" href="https://secure.viewer.zmags.com/publication/756d7a27?page=79"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 80" href="https://secure.viewer.zmags.com/publication/756d7a27?page=80"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 81" href="https://secure.viewer.zmags.com/publication/756d7a27?page=81"> Transparency </a> <a title="Clincal Trials Supply Handbook 2019 page 82" href="https://secure.viewer.zmags.com/publication/756d7a27?page=82"> CLINICAL SUPPLY TECHNOLOGY Uncertain Government</a> <a title="Clincal Trials Supply Handbook 2019 page 83" href="https://secure.viewer.zmags.com/publication/756d7a27?page=83"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 84" href="https://secure.viewer.zmags.com/publication/756d7a27?page=84"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 85" href="https://secure.viewer.zmags.com/publication/756d7a27?page=85"> have as many products being investigated at any o</a> <a title="Clincal Trials Supply Handbook 2019 page 86" href="https://secure.viewer.zmags.com/publication/756d7a27?page=86"> CLINICAL SUPPLY TECHNOLOGY </a> <a title="Clincal Trials Supply Handbook 2019 page 87" href="https://secure.viewer.zmags.com/publication/756d7a27?page=87"> CLINICAL SUPPLY TECHNOLOGY Convenience to carry</a> <a title="Clincal Trials Supply Handbook 2019 page 88" href="https://secure.viewer.zmags.com/publication/756d7a27?page=88"> CLINICAL SUPPLY TECHNOLOGY Category </a> <a title="Clincal Trials Supply Handbook 2019 page 89" href="https://secure.viewer.zmags.com/publication/756d7a27?page=89"> CLINICAL SUPPLY TECHNOLOGY Read-out of the QR </a> <a title="Clincal Trials Supply Handbook 2019 page 90" href="https://secure.viewer.zmags.com/publication/756d7a27?page=90"> SUPPLIERS Supplier Directory 4G Clinical www.</a> <a title="Clincal Trials Supply Handbook 2019 page 91" href="https://secure.viewer.zmags.com/publication/756d7a27?page=91"> Bellwyck Pharma Services www.bellwyck.com Packagi</a> <a title="Clincal Trials Supply Handbook 2019 page 92" href="https://secure.viewer.zmags.com/publication/756d7a27?page=92"> SUPPLIERS Client-Pharma www.client-pharma.com C</a> <a title="Clincal Trials Supply Handbook 2019 page 93" href="https://secure.viewer.zmags.com/publication/756d7a27?page=93"> Dryce www.dryce.eu Cold Chain Thermal Solutions D</a> <a title="Clincal Trials Supply Handbook 2019 page 94" href="https://secure.viewer.zmags.com/publication/756d7a27?page=94"> SUPPLIERS GNH India www.gnhindia.com Pharmaceut</a> <a title="Clincal Trials Supply Handbook 2019 page 95" href="https://secure.viewer.zmags.com/publication/756d7a27?page=95"> Marken www.marken.com Logistics Medidata Solutio</a> <a title="Clincal Trials Supply Handbook 2019 page 96" href="https://secure.viewer.zmags.com/publication/756d7a27?page=96"> SUPPLIERS Piramal Pharma Solutions www.piramalp</a> <a title="Clincal Trials Supply Handbook 2019 page 97" href="https://secure.viewer.zmags.com/publication/756d7a27?page=97"> Sharp Clinical Services Sharp Cl</a> <a title="Clincal Trials Supply Handbook 2019 page 98" href="https://secure.viewer.zmags.com/publication/756d7a27?page=98"> SUPPLIERS Veracity Logic www.veracitylogic.com I</a> <a title="Clincal Trials Supply Handbook 2019 page 99" href="https://secure.viewer.zmags.com/publication/756d7a27?page=99"> </a> <a title="Clincal Trials Supply Handbook 2019 page 100" href="https://secure.viewer.zmags.com/publication/756d7a27?page=100"> </a> <a title="Clincal Trials Supply Handbook 2019 page 101" href="https://secure.viewer.zmags.com/publication/756d7a27?page=101"> CLINICAL TRIAL SUPPLY HANDBOOK 2019</a>