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<br /> Clinical<br /> Trial Supply<br /> Handbook 2021<br /> The go-to guide for professionals in the global clinical supply space<br /> www.arena-international.com/healthcare<br /> makes life easier<br /> Real-time is too late. Be anticipatory!<br /> A cutting edge single CTAMS platform<br /> feel relaxed<br /> DQGFRQÀGHQW<br /> “S-CLINICA is my vendor for complex projects”<br /> - Top-5 Pharma-Biotech Clients<br /> Advanced technology<br /> · Easy start with limited study<br /> information<br /> · 100% Flexible<br /> Studies of any complexity<br /> Smooth change management<br /> · Anticipatory risk control<br /> · No supply waste!<br /> · Single platform for IRT +<br /> Supply Forecasting<br /> True Partnership<br /> · Proven record of successful<br /> partnerships<br /> · Robust expertise<br /> · Client focus<br /> clin<a title="CTS Handbook 2021 page 1" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=1"> Clinical Trial Supply Handbook 2021 The go-to gui</a> <a title="CTS Handbook 2021 page 2" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=2"> makes life easier Real-time is too late. Be antic</a> <a title="CTS Handbook 2021 page 3" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=3"> Clinical Trial Supply Handbook 2021 Portfolio le</a> <a title="CTS Handbook 2021 page 4" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=4"> CONTENTS Operations 6 Quality control L</a> <a title="CTS Handbook 2021 page 5" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=5"> 40 Why flexibility is important in clinical trial</a> <a title="CTS Handbook 2021 page 6" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=6"> OPERATIONS Quality control Lance De Souza, </a> <a title="CTS Handbook 2021 page 7" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=7"> pre-approval inspection is conducted, an integrat</a> <a title="CTS Handbook 2021 page 8" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=8"> OPERATIONS and once it is sent to the FDA, it </a> <a title="CTS Handbook 2021 page 9" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=9"> Your products are highly sensitive to temperature</a> <a title="CTS Handbook 2021 page 10" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=10"> OPERATIONS The role of comparators in clinic</a> <a title="CTS Handbook 2021 page 11" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=11"> therapies that are less effective than trea</a> <a title="CTS Handbook 2021 page 12" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=12"> OPERATIONS Supplying specific tested batches of</a> <a title="CTS Handbook 2021 page 13" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=13"> Safeguarding the progress of medicine. CSI is the</a> <a title="CTS Handbook 2021 page 14" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=14"> OPERATIONS The early bird Tina Conkic, drug</a> <a title="CTS Handbook 2021 page 15" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=15"> patients that signed their informed consent, in c</a> <a title="CTS Handbook 2021 page 16" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=16"> OPERATIONS doctors (MDs) – principal investiga</a> <a title="CTS Handbook 2021 page 17" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=17"> Clinical Trial "oѴ†ঞomv m;‰-rruo-1_|oѴb</a> <a title="CTS Handbook 2021 page 18" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=18"> OPERATIONS Clinical trial comparator challen</a> <a title="CTS Handbook 2021 page 19" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=19"> Interestingly, value was selected by only 17.5% o</a> <a title="CTS Handbook 2021 page 20" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=20"> OPERATIONS Enable next-level direct-to- pati</a> <a title="CTS Handbook 2021 page 21" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=21"> And finally, it's important to set realis</a> <a title="CTS Handbook 2021 page 22" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=22"> OPERATIONS Trials and errors Kaitlin Bova, </a> <a title="CTS Handbook 2021 page 23" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=23"> OPERATIONS Summary of medication error risks fo</a> <a title="CTS Handbook 2021 page 24" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=24"> OPERATIONS „c</a> <a title="CTS Handbook 2021 page 25" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=25"> </a> <a title="CTS Handbook 2021 page 26" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=26"> TECHNOLOGY Block by block There are a numbe</a> <a title="CTS Handbook 2021 page 27" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=27"> data. As the only proof of data is the data of pr</a> <a title="CTS Handbook 2021 page 28" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=28"> TECHNOLOGY are tracked </a> <a title="CTS Handbook 2021 page 29" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=29"> </a> <a title="CTS Handbook 2021 page 30" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=30"> TECHNOLOGY The importance of being a network</a> <a title="CTS Handbook 2021 page 31" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=31"> of patients in clinical trials, stasis betw</a> <a title="CTS Handbook 2021 page 32" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=32"> TECHNOLOGY Data driven Dr Prasun J Mishra, </a> <a title="CTS Handbook 2021 page 33" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=33"> TECHNOLOGY Figure 1: An advanced digital supply</a> <a title="CTS Handbook 2021 page 34" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=34"> TECHNOLOGY Figure 2: The shift from traditional</a> <a title="CTS Handbook 2021 page 35" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=35"> </a> <a title="CTS Handbook 2021 page 36" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=36"> TECHNOLOLGY Move to the algorithm Craig Moo</a> <a title="CTS Handbook 2021 page 37" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=37"> and delivering medication?' IRT tries to make sur</a> <a title="CTS Handbook 2021 page 38" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=38"> TECHNOLOLGY respond. There </a> <a title="CTS Handbook 2021 page 39" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=39"> </a> <a title="CTS Handbook 2021 page 40" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=40"> TECHNOLOGY Why flexibility is important in c</a> <a title="CTS Handbook 2021 page 41" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=41"> „problems with individual kits at warehouse, </a> <a title="CTS Handbook 2021 page 42" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=42"> TECHNOLOGY Stay on track Ben Taylor, CEO o</a> <a title="CTS Handbook 2021 page 43" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=43"> database systems. These private databases allow e</a> <a title="CTS Handbook 2021 page 44" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=44"> TECHNOLOGY database, no single user or or</a> <a title="CTS Handbook 2021 page 45" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=45"> YOUR BRIDGE BETWEEN LIFE-CHANGING THERAPIES AND P</a> <a title="CTS Handbook 2021 page 46" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=46"> SUPPLY & LOGISTICS The wall of regulation J</a> <a title="CTS Handbook 2021 page 47" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=47"> with perinatal or postnatal tissue stem cells. Th</a> <a title="CTS Handbook 2021 page 48" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=48"> SUPPLY & LOGISTICS achieving the reliability t</a> <a title="CTS Handbook 2021 page 49" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=49"> supplying clinical trials of the future. ready to</a> <a title="CTS Handbook 2021 page 50" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=50"> Clinical trial supply planning *R%H\RQG)RUHFDVWLQ</a> <a title="CTS Handbook 2021 page 51" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=51"> Decision* Optimized Overage Baseline </a> <a title="CTS Handbook 2021 page 52" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=52"> SUPPLY & LOGISTICS A strong network David L</a> <a title="CTS Handbook 2021 page 53" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=53"> farmer to grow the grain – complicated by many in</a> <a title="CTS Handbook 2021 page 54" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=54"> SUPPLY & LOGISTICS Fine tuning As part of m</a> <a title="CTS Handbook 2021 page 55" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=55"> The SMO Group is in the front line of servicing c</a> <a title="CTS Handbook 2021 page 56" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=56"> SUPPLY & LOGISTICS Cut to commercial Prasha</a> <a title="CTS Handbook 2021 page 57" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=57"> supply chains are not necessarily technical and e</a> <a title="CTS Handbook 2021 page 58" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=58"> SUPPLY & LOGISTICS on the other hand, are glob</a> <a title="CTS Handbook 2021 page 59" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=59"> No patient goes without. No study gets delayed.</a> <a title="CTS Handbook 2021 page 60" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=60"> SUPPLY & LOGISTICS Shape the future of clini</a> <a title="CTS Handbook 2021 page 61" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=61"> business risk? How can the clinical trial process</a> <a title="CTS Handbook 2021 page 62" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=62"> In times of uncertainty, our mission remains clea</a> <a title="CTS Handbook 2021 page 63" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=63"> COLD CHAIN Ahead of the programme Eric Cook</a> <a title="CTS Handbook 2021 page 64" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=64"> Comparator Sourcing Specialists with 18 years of </a> <a title="CTS Handbook 2021 page 65" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=65"> important category to the FDA during inspections </a> <a title="CTS Handbook 2021 page 66" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=66"> COLD CHAIN examples to review, to give you an </a> <a title="CTS Handbook 2021 page 67" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=67"> JOIN OUR CLINICAL TRIAL SUPPLY COMMUNITY </a> <a title="CTS Handbook 2021 page 68" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=68"> COLD CHAIN Temperature control Rich Barrall</a> <a title="CTS Handbook 2021 page 69" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=69"> Aside from packaging, what other areas in the tem</a> <a title="CTS Handbook 2021 page 70" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=70"> COVID-19 The world under Covid-19 The US Cus</a> <a title="CTS Handbook 2021 page 71" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=71"> potentially harmful interceptions included bio</a> <a title="CTS Handbook 2021 page 72" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=72"> COVID-19 A </a> <a title="CTS Handbook 2021 page 73" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=73"> Clinical Trials Addressing the key challenges in </a> <a title="CTS Handbook 2021 page 74" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=74"> COVID-19 Lead the way Alexander Asnis, asso</a> <a title="CTS Handbook 2021 page 75" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=75"> We have found several of the following me</a> <a title="CTS Handbook 2021 page 76" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=76"> COVID-19 „clinical supplies packaging agreemen</a> <a title="CTS Handbook 2021 page 77" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=77"> Your clinical trial partner for smarter equipment</a> <a title="CTS Handbook 2021 page 78" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=78"> COVID-19 Open the door to successful decentr</a> <a title="CTS Handbook 2021 page 79" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=79"> the company can advise on the most appropriate ch</a> <a title="CTS Handbook 2021 page 80" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=80"> Clinical Trial Supply Technologies SupplyRx is </a> <a title="CTS Handbook 2021 page 81" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=81"> COVID-19 It takes two Sean Walsh, executive</a> <a title="CTS Handbook 2021 page 82" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=82"> COVID-19 Figure 1: </a> <a title="CTS Handbook 2021 page 83" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=83"> complexity. Most of the studies listed are non-US</a> <a title="CTS Handbook 2021 page 84" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=84"> COVID-19 early </a> <a title="CTS Handbook 2021 page 85" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=85"> streamlining Your Supply Chain </a> <a title="CTS Handbook 2021 page 86" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=86"> SUPPLIERS GUIDE Suppliers directory 4G Clin</a> <a title="CTS Handbook 2021 page 87" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=87"> Catalent Clinical Supply www.clinical.catalent.co</a> <a title="CTS Handbook 2021 page 88" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=88"> SUPPLIERS GUIDE Experic www.expericservices.co</a> <a title="CTS Handbook 2021 page 89" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=89"> PCI Clinical Services www.pciservices.com/clinica</a> <a title="CTS Handbook 2021 page 90" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=90"> SUPPLIERS GUIDE Tanner Pharma Group www.tanner</a> <a title="CTS Handbook 2021 page 91" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=91"> Safeguarding the progress of medicine. CSI is the</a> <a title="CTS Handbook 2021 page 92" href="https://secure.viewer.zmags.com/publication/d01ca7ae?page=92"> Clinical Trial "oѴ†ঞomv m;‰-rruo-1_|oѴb</a>