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<br /> Outsourcing in<br /> Clinical Trials<br /> Handbook 2021<br /> The go-to guide for professionals in the global clinical trial 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 <a title="OCT Handbook 2021 page 1" href="https://secure.viewer.zmags.com/publication/c004e33c?page=1"> Outsourcing in Clinical Trials Handbook 2021 The </a> <a title="OCT Handbook 2021 page 2" href="https://secure.viewer.zmags.com/publication/c004e33c?page=2"> makes life easier Real-time is too late. Be antic</a> <a title="OCT Handbook 2021 page 3" href="https://secure.viewer.zmags.com/publication/c004e33c?page=3"> Outsourcing in Clinical Trials Handbook 2021 Por</a> <a title="OCT Handbook 2021 page 4" href="https://secure.viewer.zmags.com/publication/c004e33c?page=4"> CONTENTS Outsourcing 9 Follow the leader</a> <a title="OCT Handbook 2021 page 5" href="https://secure.viewer.zmags.com/publication/c004e33c?page=5"> 62 Time to go private Dr Ben Locwin</a> <a title="OCT Handbook 2021 page 6" href="https://secure.viewer.zmags.com/publication/c004e33c?page=6"> OUTSOURCING AI for medical writing: assistan</a> <a title="OCT Handbook 2021 page 7" href="https://secure.viewer.zmags.com/publication/c004e33c?page=7"> the numbers in tables in the text, I agreed that </a> <a title="OCT Handbook 2021 page 8" href="https://secure.viewer.zmags.com/publication/c004e33c?page=8"> WRITING REGULATORY DOCUMENTS IS ABOUT TO </a> <a title="OCT Handbook 2021 page 9" href="https://secure.viewer.zmags.com/publication/c004e33c?page=9"> OUTSOURCING Follow the leader Kevin Crawfor</a> <a title="OCT Handbook 2021 page 10" href="https://secure.viewer.zmags.com/publication/c004e33c?page=10"> The Right Choice. Biopharmaceutical companies co</a> <a title="OCT Handbook 2021 page 11" href="https://secure.viewer.zmags.com/publication/c004e33c?page=11"> Often, the leader does not intend to make error</a> <a title="OCT Handbook 2021 page 12" href="https://secure.viewer.zmags.com/publication/c004e33c?page=12"> OUTSOURCING It's often difficult to accep</a> <a title="OCT Handbook 2021 page 13" href="https://secure.viewer.zmags.com/publication/c004e33c?page=13"> QPS is prepared to support the fight against COVID</a> <a title="OCT Handbook 2021 page 14" href="https://secure.viewer.zmags.com/publication/c004e33c?page=14"> OUTSOURCING Resilience amid Covid-19 QPS di</a> <a title="OCT Handbook 2021 page 15" href="https://secure.viewer.zmags.com/publication/c004e33c?page=15"> can minimise the time staff members spend i</a> <a title="OCT Handbook 2021 page 16" href="https://secure.viewer.zmags.com/publication/c004e33c?page=16"> OUTSOURCING Come together Karrie Hillsinge</a> <a title="OCT Handbook 2021 page 17" href="https://secure.viewer.zmags.com/publication/c004e33c?page=17"> relationship can be what excels your study </a> <a title="OCT Handbook 2021 page 18" href="https://secure.viewer.zmags.com/publication/c004e33c?page=18"> OUTSOURCING </a> <a title="OCT Handbook 2021 page 19" href="https://secure.viewer.zmags.com/publication/c004e33c?page=19"> COMPREHENSIVE CLINICAL DATA COLLECTION SERVICES </a> <a title="OCT Handbook 2021 page 20" href="https://secure.viewer.zmags.com/publication/c004e33c?page=20"> OUTSOURCING A clinical research data collect</a> <a title="OCT Handbook 2021 page 21" href="https://secure.viewer.zmags.com/publication/c004e33c?page=21"> any regulated study. It is important to discuss a</a> <a title="OCT Handbook 2021 page 22" href="https://secure.viewer.zmags.com/publication/c004e33c?page=22"> Simplify your A scalable approach to optimizing</a> <a title="OCT Handbook 2021 page 23" href="https://secure.viewer.zmags.com/publication/c004e33c?page=23"> IN PARTNERSHIP A trusted global partner Ava</a> <a title="OCT Handbook 2021 page 24" href="https://secure.viewer.zmags.com/publication/c004e33c?page=24"> OUTSOURCING Find the funds Roger Nolan, pr</a> <a title="OCT Handbook 2021 page 25" href="https://secure.viewer.zmags.com/publication/c004e33c?page=25"> success. For example, academic reviewers do not o</a> <a title="OCT Handbook 2021 page 26" href="https://secure.viewer.zmags.com/publication/c004e33c?page=26"> OUTSOURCING </a> <a title="OCT Handbook 2021 page 27" href="https://secure.viewer.zmags.com/publication/c004e33c?page=27"> Safeguarding the progress of medicine. CSI is the</a> <a title="OCT Handbook 2021 page 28" href="https://secure.viewer.zmags.com/publication/c004e33c?page=28"> OUTSOURCING Data-driven sourcing strategies </a> <a title="OCT Handbook 2021 page 29" href="https://secure.viewer.zmags.com/publication/c004e33c?page=29"> Recombinant human insulin – used to treat type</a> <a title="OCT Handbook 2021 page 30" href="https://secure.viewer.zmags.com/publication/c004e33c?page=30"> OUTSOURCING Penetration of biosimilars across </a> <a title="OCT Handbook 2021 page 31" href="https://secure.viewer.zmags.com/publication/c004e33c?page=31"> When planning a trial that is going to us</a> <a title="OCT Handbook 2021 page 32" href="https://secure.viewer.zmags.com/publication/c004e33c?page=32"> OUTSOURCING Formulated for the clinic Lisa</a> <a title="OCT Handbook 2021 page 33" href="https://secure.viewer.zmags.com/publication/c004e33c?page=33"> one vendor with an integrated offering at t</a> <a title="OCT Handbook 2021 page 34" href="https://secure.viewer.zmags.com/publication/c004e33c?page=34"> OUTSOURCING European sites are defined. Early </a> <a title="OCT Handbook 2021 page 35" href="https://secure.viewer.zmags.com/publication/c004e33c?page=35"> supplying clinical trials of the future. ready to</a> <a title="OCT Handbook 2021 page 36" href="https://secure.viewer.zmags.com/publication/c004e33c?page=36"> WE ACCELERATE YOUR CLINICAL DEVELOPMENT </a> <a title="OCT Handbook 2021 page 37" href="https://secure.viewer.zmags.com/publication/c004e33c?page=37"> OUTSOURCING A step-by-step guide Brian J N</a> <a title="OCT Handbook 2021 page 38" href="https://secure.viewer.zmags.com/publication/c004e33c?page=38"> </a> <a title="OCT Handbook 2021 page 39" href="https://secure.viewer.zmags.com/publication/c004e33c?page=39"> OUTSOURCING Clinical activity assessment Activit</a> <a title="OCT Handbook 2021 page 40" href="https://secure.viewer.zmags.com/publication/c004e33c?page=40"> OUTSOURCING Quality management system elements</a> <a title="OCT Handbook 2021 page 41" href="https://secure.viewer.zmags.com/publication/c004e33c?page=41"> </a> <a title="OCT Handbook 2021 page 42" href="https://secure.viewer.zmags.com/publication/c004e33c?page=42"> OUTSOURCING Deliver agility without compromi</a> <a title="OCT Handbook 2021 page 43" href="https://secure.viewer.zmags.com/publication/c004e33c?page=43"> and most importantly, Cryoniss'culture, are found</a> <a title="OCT Handbook 2021 page 44" href="https://secure.viewer.zmags.com/publication/c004e33c?page=44"> TECHNOLOGY & DATA MANAGEMENT A new lea</a> <a title="OCT Handbook 2021 page 45" href="https://secure.viewer.zmags.com/publication/c004e33c?page=45"> something with technology, does not mean that we </a> <a title="OCT Handbook 2021 page 46" href="https://secure.viewer.zmags.com/publication/c004e33c?page=46"> TECHNOLOGY & DATA MANAGEMENT </a> <a title="OCT Handbook 2021 page 47" href="https://secure.viewer.zmags.com/publication/c004e33c?page=47"> </a> <a title="OCT Handbook 2021 page 48" href="https://secure.viewer.zmags.com/publication/c004e33c?page=48"> TECHNOLOGY & DATA MANAGEMENT A success</a> <a title="OCT Handbook 2021 page 49" href="https://secure.viewer.zmags.com/publication/c004e33c?page=49"> controlled temperature shipper and a temperature-</a> <a title="OCT Handbook 2021 page 50" href="https://secure.viewer.zmags.com/publication/c004e33c?page=50"> TECHNOLOGY & DATA MANAGEMENT The healt</a> <a title="OCT Handbook 2021 page 51" href="https://secure.viewer.zmags.com/publication/c004e33c?page=51"> the UK spends 15% of its GDP on social care and 8</a> <a title="OCT Handbook 2021 page 52" href="https://secure.viewer.zmags.com/publication/c004e33c?page=52"> TECHNOLOGY & DATA MANAGEMENT unsafe area</a> <a title="OCT Handbook 2021 page 53" href="https://secure.viewer.zmags.com/publication/c004e33c?page=53"> Every clinical trial starts with a question. At T</a> <a title="OCT Handbook 2021 page 54" href="https://secure.viewer.zmags.com/publication/c004e33c?page=54"> TECHNOLOGY & DATA MANAGEMENT It's time</a> <a title="OCT Handbook 2021 page 55" href="https://secure.viewer.zmags.com/publication/c004e33c?page=55"> A way for sponsors to differentiate themselves</a> <a title="OCT Handbook 2021 page 56" href="https://secure.viewer.zmags.com/publication/c004e33c?page=56"> TECHNOLOGY & DATA MANAGEMENT The block</a> <a title="OCT Handbook 2021 page 57" href="https://secure.viewer.zmags.com/publication/c004e33c?page=57"> number of healthy, paid volunteers. This is also </a> <a title="OCT Handbook 2021 page 58" href="https://secure.viewer.zmags.com/publication/c004e33c?page=58"> TECHNOLOGY & DATA MANAGEMENT „Keeping tr</a> <a title="OCT Handbook 2021 page 59" href="https://secure.viewer.zmags.com/publication/c004e33c?page=59"> </a> <a title="OCT Handbook 2021 page 60" href="https://secure.viewer.zmags.com/publication/c004e33c?page=60"> TECHNOLOGY & DATA MANAGEMENT The remot</a> <a title="OCT Handbook 2021 page 61" href="https://secure.viewer.zmags.com/publication/c004e33c?page=61"> IN PARTNERSHIP </a> <a title="OCT Handbook 2021 page 62" href="https://secure.viewer.zmags.com/publication/c004e33c?page=62"> TECHNOLOGY & DATA MANAGEMENT Time to g</a> <a title="OCT Handbook 2021 page 63" href="https://secure.viewer.zmags.com/publication/c004e33c?page=63"> globally with trial data privacy, expectations of</a> <a title="OCT Handbook 2021 page 64" href="https://secure.viewer.zmags.com/publication/c004e33c?page=64"> TECHNOLOGY & DATA MANAGEMENT </a> <a title="OCT Handbook 2021 page 65" href="https://secure.viewer.zmags.com/publication/c004e33c?page=65"> MEDICAL DEVICES </a> <a title="OCT Handbook 2021 page 66" href="https://secure.viewer.zmags.com/publication/c004e33c?page=66"> MEDICAL DEVICES Allergan has produced medical </a> <a title="OCT Handbook 2021 page 67" href="https://secure.viewer.zmags.com/publication/c004e33c?page=67"> Globally, there are many countries that are</a> <a title="OCT Handbook 2021 page 68" href="https://secure.viewer.zmags.com/publication/c004e33c?page=68"> MEDICAL DEVICES Uncommon sensors Dr Ben Hw</a> <a title="OCT Handbook 2021 page 69" href="https://secure.viewer.zmags.com/publication/c004e33c?page=69"> patch that adheres to the skin. The patch, in tur</a> <a title="OCT Handbook 2021 page 70" href="https://secure.viewer.zmags.com/publication/c004e33c?page=70"> MEDICAL DEVICES </a> <a title="OCT Handbook 2021 page 71" href="https://secure.viewer.zmags.com/publication/c004e33c?page=71"> Clinical Trials Addressing the key challenges in </a> <a title="OCT Handbook 2021 page 72" href="https://secure.viewer.zmags.com/publication/c004e33c?page=72"> Always Challenge Conventional Thinking. </a> <a title="OCT Handbook 2021 page 73" href="https://secure.viewer.zmags.com/publication/c004e33c?page=73"> MEDICAL DEVICES Keep on track John Shillin</a> <a title="OCT Handbook 2021 page 74" href="https://secure.viewer.zmags.com/publication/c004e33c?page=74"> Specialist Drug Development Solutions Ergomed pr</a> <a title="OCT Handbook 2021 page 75" href="https://secure.viewer.zmags.com/publication/c004e33c?page=75"> Reference blood g</a> <a title="OCT Handbook 2021 page 76" href="https://secure.viewer.zmags.com/publication/c004e33c?page=76"> MEDICAL DEVICES </a> <a title="OCT Handbook 2021 page 77" href="https://secure.viewer.zmags.com/publication/c004e33c?page=77"> </a> <a title="OCT Handbook 2021 page 78" href="https://secure.viewer.zmags.com/publication/c004e33c?page=78"> MEDICAL DEVICES The journey of extractables </a> <a title="OCT Handbook 2021 page 79" href="https://secure.viewer.zmags.com/publication/c004e33c?page=79"> Extracts containing the extractables in higher co</a> <a title="OCT Handbook 2021 page 80" href="https://secure.viewer.zmags.com/publication/c004e33c?page=80"> COVID-19 Expect the unexpected Helén Johan</a> <a title="OCT Handbook 2021 page 81" href="https://secure.viewer.zmags.com/publication/c004e33c?page=81"> – and predefined actions to be taken if the risk </a> <a title="OCT Handbook 2021 page 82" href="https://secure.viewer.zmags.com/publication/c004e33c?page=82"> COVID-19 – a term that </a> <a title="OCT Handbook 2021 page 83" href="https://secure.viewer.zmags.com/publication/c004e33c?page=83"> Agile innovations for virtual clinical trial succ</a> <a title="OCT Handbook 2021 page 84" href="https://secure.viewer.zmags.com/publication/c004e33c?page=84"> COVID-19 Choosing an IRT partner to extend t</a> <a title="OCT Handbook 2021 page 85" href="https://secure.viewer.zmags.com/publication/c004e33c?page=85"> vendor offers all the capabilities that the trial</a> <a title="OCT Handbook 2021 page 86" href="https://secure.viewer.zmags.com/publication/c004e33c?page=86"> </a> <a title="OCT Handbook 2021 page 87" href="https://secure.viewer.zmags.com/publication/c004e33c?page=87"> COVID-19 Clinical dropout David Daily, CEO </a> <a title="OCT Handbook 2021 page 88" href="https://secure.viewer.zmags.com/publication/c004e33c?page=88"> COVID-19 injectable drug is tested. Consequent</a> <a title="OCT Handbook 2021 page 89" href="https://secure.viewer.zmags.com/publication/c004e33c?page=89"> " (MPCBM $30 XJUI $IJOFTF )FSJUBHF 5JHFSNFE (</a> <a title="OCT Handbook 2021 page 90" href="https://secure.viewer.zmags.com/publication/c004e33c?page=90"> COVID-19 Figure 2: Biological versus non-biolog</a> <a title="OCT Handbook 2021 page 91" href="https://secure.viewer.zmags.com/publication/c004e33c?page=91"> Combining cutting-edge science with high</a> <a title="OCT Handbook 2021 page 92" href="https://secure.viewer.zmags.com/publication/c004e33c?page=92"> COVID-19 Lessons learned from setting and sc</a> <a title="OCT Handbook 2021 page 93" href="https://secure.viewer.zmags.com/publication/c004e33c?page=93"> RNA extraction methods showing very contrasting p</a> <a title="OCT Handbook 2021 page 94" href="https://secure.viewer.zmags.com/publication/c004e33c?page=94"> Scenario Modeling ‰b|_Ɠ"†rrѴ‹Ť "-l;om1;r|ĺ m|bu;</a> <a title="OCT Handbook 2021 page 95" href="https://secure.viewer.zmags.com/publication/c004e33c?page=95"> COVID-19 Trial and error </a> <a title="OCT Handbook 2021 page 96" href="https://secure.viewer.zmags.com/publication/c004e33c?page=96"> COVID-19 – possibly in regions where implement</a> <a title="OCT Handbook 2021 page 97" href="https://secure.viewer.zmags.com/publication/c004e33c?page=97"> </a> <a title="OCT Handbook 2021 page 98" href="https://secure.viewer.zmags.com/publication/c004e33c?page=98"> COVID-19 Improving fundamental clinical trial </a> <a title="OCT Handbook 2021 page 99" href="https://secure.viewer.zmags.com/publication/c004e33c?page=99"> designed to allow drug development teams – includ</a> <a title="OCT Handbook 2021 page 100" href="https://secure.viewer.zmags.com/publication/c004e33c?page=100"> </a> <a title="OCT Handbook 2021 page 101" href="https://secure.viewer.zmags.com/publication/c004e33c?page=101"> COVID-19 All systems are go James Stout, v</a> <a title="OCT Handbook 2021 page 102" href="https://secure.viewer.zmags.com/publication/c004e33c?page=102"> COVID-19 The BALS employs live porcine h</a> <a title="OCT Handbook 2021 page 103" href="https://secure.viewer.zmags.com/publication/c004e33c?page=103"> </a> <a title="OCT Handbook 2021 page 104" href="https://secure.viewer.zmags.com/publication/c004e33c?page=104"> COVID-19 </a> <a title="OCT Handbook 2021 page 105" href="https://secure.viewer.zmags.com/publication/c004e33c?page=105"> </a> <a title="OCT Handbook 2021 page 106" href="https://secure.viewer.zmags.com/publication/c004e33c?page=106"> SUPPLIERS DIRECTORY Suppliers Directory 4Cl</a> <a title="OCT Handbook 2021 page 107" href="https://secure.viewer.zmags.com/publication/c004e33c?page=107"> ARTIALIS SA www.artialis.com Category: Musculoske</a> <a title="OCT Handbook 2021 page 108" href="https://secure.viewer.zmags.com/publication/c004e33c?page=108"> SUPPLIERS DIRECTORY BioTel Research www.gobio.</a> <a title="OCT Handbook 2021 page 109" href="https://secure.viewer.zmags.com/publication/c004e33c?page=109"> Clinical Reference Laboratory www.crlcorp.com Cat</a> <a title="OCT Handbook 2021 page 110" href="https://secure.viewer.zmags.com/publication/c004e33c?page=110"> SUPPLIERS DIRECTORY CSM, a Clinigen company w</a> <a title="OCT Handbook 2021 page 111" href="https://secure.viewer.zmags.com/publication/c004e33c?page=111"> Global Words www.globalwords.com Category: Langua</a> <a title="OCT Handbook 2021 page 112" href="https://secure.viewer.zmags.com/publication/c004e33c?page=112"> SUPPLIERS DIRECTORY KCAS Bioanalytical & Bioma</a> <a title="OCT Handbook 2021 page 113" href="https://secure.viewer.zmags.com/publication/c004e33c?page=113"> Medpace www.medpace.com Category: CRO MedPoint D</a> <a title="OCT Handbook 2021 page 114" href="https://secure.viewer.zmags.com/publication/c004e33c?page=114"> SUPPLIERS DIRECTORY Ora, Inc. Oraclinical.com</a> <a title="OCT Handbook 2021 page 115" href="https://secure.viewer.zmags.com/publication/c004e33c?page=115"> Quality Data Services, Inc. www.qdservices.com Ca</a> <a title="OCT Handbook 2021 page 116" href="https://secure.viewer.zmags.com/publication/c004e33c?page=116"> SUPPLIERS DIRECTORY SGS www.sgs.com Category: </a> <a title="OCT Handbook 2021 page 117" href="https://secure.viewer.zmags.com/publication/c004e33c?page=117"> Trialbee www.trialbee.com Category: Patient Recru</a> <a title="OCT Handbook 2021 page 118" href="https://secure.viewer.zmags.com/publication/c004e33c?page=118"> Your specialized partner from no</a> <a title="OCT Handbook 2021 page 119" href="https://secure.viewer.zmags.com/publication/c004e33c?page=119"> Simplify your A scalable approach to optimizing</a> <a title="OCT Handbook 2021 page 120" href="https://secure.viewer.zmags.com/publication/c004e33c?page=120"> WRITING REGULATORY DOCUMENTS IS ABOUT TO </a>