{"product_id":"supply-chain-planning-for-clinical-trials-a-practical-guide-paperback-softback-9781394179558","title":"Supply Chain Planning for Clinical Trials; A Practical Guide (Paperback \/ softback) 9781394179558","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003eSupply Chain Planning for Clinical Trials\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eA Practical Guide\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eRyan Mills (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781394179558, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback \/ softback, published 26 June 2024\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e496 pages\u003cbr\u003e25.2 x 17.5 x 2.5 cm, 0.998 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e\u003cb\u003eEnsure your clinical trial supply chain is running smoothly with this practical guide\u003c\/b\u003e \u003c\/p\u003e\n\u003cp\u003eClinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eSupply Chain Planning for Clinical Trials \u003c\/i\u003eoffers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eSupply Chain Planning for Clinical Trials \u003c\/i\u003ereaders will also find: \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eTools for minimizing risk and expense by optimizing the relationship between supply and demand \u003c\/li\u003e\n\u003cli\u003eDetailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management \u003c\/li\u003e\n\u003cli\u003eSpreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eSupply Chain Planning for Clinical Trails \u003c\/i\u003eis ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.\u003c\/p\u003e\u003c\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface xiii\u003c\/p\u003e \u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Supply Chain Management 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Supply Chain Management 1\u003c\/p\u003e \u003cp\u003e1.2 Plan 3\u003c\/p\u003e \u003cp\u003e1.3 Source 6\u003c\/p\u003e \u003cp\u003e1.4 Make 8\u003c\/p\u003e \u003cp\u003e1.5 Deliver\/Return 11\u003c\/p\u003e \u003cp\u003e1.6 Data, Analytics, and Metrics 12\u003c\/p\u003e \u003cp\u003e1.7 The People–Process–Technology Framework 16\u003c\/p\u003e \u003cp\u003e1.8 Key Takeaways 16\u003c\/p\u003e \u003cp\u003eNotes 17\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Introduction to Clinical Trials 19\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction to Clinical Trials 19\u003c\/p\u003e \u003cp\u003e2.2 A Conversation About Clinical Trials 19\u003c\/p\u003e \u003cp\u003e2.3 Intrinsic Elements of a Clinical Trial 23\u003c\/p\u003e \u003cp\u003e2.4 Extrinsic Elements of a Clinical Trial 26\u003c\/p\u003e \u003cp\u003e2.5 Preclinical Drug Development 27\u003c\/p\u003e \u003cp\u003e2.6 The Clinical Development Plan 28\u003c\/p\u003e \u003cp\u003e2.7 Phase I Clinical Trials 29\u003c\/p\u003e \u003cp\u003e2.8 Clinical Pharmacology Trials 30\u003c\/p\u003e \u003cp\u003e2.9 Phase II and III Clinical Trials 31\u003c\/p\u003e \u003cp\u003e2.10 Adaptive Trials 32\u003c\/p\u003e \u003cp\u003e2.11 Master Protocol Designs – Platform, Basket, and Umbrella Trials 32\u003c\/p\u003e \u003cp\u003e2.12 Decentralized Clinical Trials 33\u003c\/p\u003e \u003cp\u003e2.13 Post-marketing Clinical Trials 34\u003c\/p\u003e \u003cp\u003e2.14 Clinical Trial Stakeholder Summary 34\u003c\/p\u003e \u003cp\u003e2.15 Trends in Clinical Trial Design and Conduct 36\u003c\/p\u003e \u003cp\u003e2.16 Key Takeaways 37\u003c\/p\u003e \u003cp\u003eNotes 38\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Introduction to the Clinical Trial Supply Chain 39\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction to the Clinical Trial Supply Chain 39\u003c\/p\u003e \u003cp\u003e3.2 Drug Modalities 40\u003c\/p\u003e \u003cp\u003e3.3 Starting Materials and Drug Substance 43\u003c\/p\u003e \u003cp\u003e3.4 Drug Product 44\u003c\/p\u003e \u003cp\u003e3.5 Analytical Development and Characterization 45\u003c\/p\u003e \u003cp\u003e3.6 Manufacturing Process Development 48\u003c\/p\u003e \u003cp\u003e3.7 Packaging 49\u003c\/p\u003e \u003cp\u003e3.8 Labeling 51\u003c\/p\u003e \u003cp\u003e3.9 Distribution 53\u003c\/p\u003e \u003cp\u003e3.10 Clinical Trial Supply Chain Summary 54\u003c\/p\u003e \u003cp\u003e3.11 CMC Development and Manufacturing Strategy 55\u003c\/p\u003e \u003cp\u003e3.12 CMC Stakeholder Summary 57\u003c\/p\u003e \u003cp\u003e3.13 Trends in Clinical Manufacturing and Supply Chain Management 61\u003c\/p\u003e \u003cp\u003e3.14 Key Takeaways 62\u003c\/p\u003e \u003cp\u003eNotes 63\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Quality Considerations 65\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 What Is Quality? 65\u003c\/p\u003e \u003cp\u003e4.2 Good Manufacturing Practice: An Overview 67\u003c\/p\u003e \u003cp\u003e4.3 Source: Supplier Identification and Qualification 70\u003c\/p\u003e \u003cp\u003e4.4 Make: Batch Records, Sampling, Batch Release, Deviations, and Disposition 71\u003c\/p\u003e \u003cp\u003e4.5 Deliver: Good Distribution Practice, Temperature Excursions, Returns, and Recalls 73\u003c\/p\u003e \u003cp\u003e4.6 Plan: Planning Inputs and Change Management 75\u003c\/p\u003e \u003cp\u003e4.7 Preapproval Inspection 77\u003c\/p\u003e \u003cp\u003e4.8 The Qualified Person 78\u003c\/p\u003e \u003cp\u003e4.9 Key Takeaways 80\u003c\/p\u003e \u003cp\u003eNotes 81\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Regulatory Considerations 83\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction to Regulatory Applications 83\u003c\/p\u003e \u003cp\u003e5.2 Regulatory Application Content and the CTD 84\u003c\/p\u003e \u003cp\u003e5.3 Health Authority Interactions 87\u003c\/p\u003e \u003cp\u003e5.4 The Clinical Trial Regulation in the European Union 87\u003c\/p\u003e \u003cp\u003e5.5 Application Authoring, Submission, and Approval 88\u003c\/p\u003e \u003cp\u003e5.6 Amendments 90\u003c\/p\u003e \u003cp\u003e5.7 Commitments and Restrictions 92\u003c\/p\u003e \u003cp\u003e5.8 Regulatory Status Tracking 93\u003c\/p\u003e \u003cp\u003e5.9 Batch and IMP Lifecycle Management 94\u003c\/p\u003e \u003cp\u003e5.10 Process Version Management 97\u003c\/p\u003e \u003cp\u003e5.11 Key Takeaways 100\u003c\/p\u003e \u003cp\u003eNotes 101\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 RTSM and Its Role in the Clinical Supply Chain 103\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Randomization and Trial Supply Management 103\u003c\/p\u003e \u003cp\u003e6.2 RTSM Scope and Functionality 104\u003c\/p\u003e \u003cp\u003e6.3 The Kit Identifier 106\u003c\/p\u003e \u003cp\u003e6.4 IMP Supply Strategies 107\u003c\/p\u003e \u003cp\u003e6.5 IMP Expiry Management Settings 114\u003c\/p\u003e \u003cp\u003e6.6 Transactions, Alerts, and Drug Accountability 115\u003c\/p\u003e \u003cp\u003e6.7 Reports and Their Link to Demand and Supply Planning 118\u003c\/p\u003e \u003cp\u003e6.8 Additional IMP Management Considerations 119\u003c\/p\u003e \u003cp\u003e6.9 RTSM Supplier Selection 120\u003c\/p\u003e \u003cp\u003e6.10 RTSM Trends and Future Capabilities 121\u003c\/p\u003e \u003cp\u003e6.11 Key Takeaways 122\u003c\/p\u003e \u003cp\u003eNotes 123\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Supply Chain Planning for Clinical Trials 125\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Framing the Road Ahead 125\u003c\/p\u003e \u003cp\u003e7.2 Clinical Planning Objectives 126\u003c\/p\u003e \u003cp\u003e7.3 Clinical Planning Activities 127\u003c\/p\u003e \u003cp\u003e7.4 Mathematical Approaches to Clinical Planning 130\u003c\/p\u003e \u003cp\u003e7.5 The Elements of Demand and Supply Planning for Clinical Trials 130\u003c\/p\u003e \u003cp\u003e7.6 Clinical Demand and Supply Planning Business Processes 133\u003c\/p\u003e \u003cp\u003e7.7 Alternative Clinical Supply Chain Scenarios 134\u003c\/p\u003e \u003cp\u003e7.8 The Role of the Clinical Supply Chain Function 134\u003c\/p\u003e \u003cp\u003e7.9 Getting Started 137\u003c\/p\u003e \u003cp\u003e7.10 Key Takeaways 137\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Finished Product Demand Planning: Basic Concepts 139\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction to Demand Planning for Clinical Trials 139\u003c\/p\u003e \u003cp\u003e8.2 The What of Demand Forecasting: The Stockkeeping Unit 140\u003c\/p\u003e \u003cp\u003e8.3 The Where of Demand Forecasting: Depot Versus Site 143\u003c\/p\u003e \u003cp\u003e8.4 The Demand Forecast Period: Weeks Versus Months of Supply 144\u003c\/p\u003e \u003cp\u003e8.5 The Demand Forecast Table 146\u003c\/p\u003e \u003cp\u003e8.6 Forecasting Individual Subject Demand 146\u003c\/p\u003e \u003cp\u003e8.7 Forecasting Enrollment 152\u003c\/p\u003e \u003cp\u003e8.8 Overage 160\u003c\/p\u003e \u003cp\u003e8.9 Site Stocking Demand 162\u003c\/p\u003e \u003cp\u003e8.10 Total Demand and Next Steps 163\u003c\/p\u003e \u003cp\u003e8.11 The Challenge of Accuracy in Clinical Trial Demand Planning 163\u003c\/p\u003e \u003cp\u003e8.12 Key Takeaways 164\u003c\/p\u003e \u003cp\u003eNotes 165\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Finished Product Supply Planning: The Production Plan 167\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction to Supply Planning 167\u003c\/p\u003e \u003cp\u003e9.2 Min–Max Inventory Management 168\u003c\/p\u003e \u003cp\u003e9.3 Weeks-of-Supply 174\u003c\/p\u003e \u003cp\u003e9.4 The Production Plan Table 175\u003c\/p\u003e \u003cp\u003e9.5 The Impact of Future Demand on Production Order Requirements 176\u003c\/p\u003e \u003cp\u003e9.6 Selecting Supply Planning Parameters and Their Impact on Production Order Requirements 178\u003c\/p\u003e \u003cp\u003e9.7 From Requirements to Orders 181\u003c\/p\u003e \u003cp\u003e9.8 The Production Plan Summary 184\u003c\/p\u003e \u003cp\u003e9.9 Production Order Readiness 185\u003c\/p\u003e \u003cp\u003e9.10 Key Takeaways 186\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Finished Product Expiry Planning 189\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Expiry Management and the Planning Process 189\u003c\/p\u003e \u003cp\u003e10.2 First In First Out and Last In First Out Inventory Management 190\u003c\/p\u003e \u003cp\u003e10.3 The Importance of Batch Visibility 191\u003c\/p\u003e \u003cp\u003e10.4 Incorporating Expiry into the Finished Product Plan 192\u003c\/p\u003e \u003cp\u003e10.5 Forecasting Expiry Events 196\u003c\/p\u003e \u003cp\u003e10.6 Shelf-Life Extensions Versus Replacement Inventory 199\u003c\/p\u003e \u003cp\u003e10.7 Strategies for Managing Expiry Limitations 201\u003c\/p\u003e \u003cp\u003e10.8 Key Takeaways 203\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Finished Product Supply Planning: The Distribution Plan 205\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction to Distribution Planning 205\u003c\/p\u003e \u003cp\u003e11.2 Mapping the Clinical Packaging and Distribution Network 206\u003c\/p\u003e \u003cp\u003e11.3 Connecting Regional Depots to the Central Depot 209\u003c\/p\u003e \u003cp\u003e11.4 Demand and Supply Planning Parameters Revisited 212\u003c\/p\u003e \u003cp\u003e11.5 Distribution Planning Strategies 213\u003c\/p\u003e \u003cp\u003e11.6 Aggregate Finished Product Weeks-of-Supply 218\u003c\/p\u003e \u003cp\u003e11.7 The Weeks-of-Supply Summary 220\u003c\/p\u003e \u003cp\u003e11.8 The Distribution Plan Summary 220\u003c\/p\u003e \u003cp\u003e11.9 Distribution Order Readiness 222\u003c\/p\u003e \u003cp\u003e11.10 Key Takeaways 223\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Upstream Supply Planning: Primary Packaging, Drug Product, and Drug Substance 225\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Planning for Upstream Materials 225\u003c\/p\u003e \u003cp\u003e12.2 General Approach to Demand Planning for Upstream Materials 226\u003c\/p\u003e \u003cp\u003e12.3 General Approach to Supply Planning for Upstream Materials 230\u003c\/p\u003e \u003cp\u003e12.4 Upstream Supply Planning Strategies 234\u003c\/p\u003e \u003cp\u003e12.5 Small-Molecule Primary Packaging Planning 237\u003c\/p\u003e \u003cp\u003e12.6 Small-Molecule Drug Product Planning 238\u003c\/p\u003e \u003cp\u003e12.7 Small-Molecule Drug Substance Planning 239\u003c\/p\u003e \u003cp\u003e12.8 Large-Molecule Drug Product Planning 241\u003c\/p\u003e \u003cp\u003e12.9 Large-Molecule Drug Substance Planning 242\u003c\/p\u003e \u003cp\u003e12.10 The Upstream Production Plan Summary 245\u003c\/p\u003e \u003cp\u003e12.11 Upstream Production Order Readiness 246\u003c\/p\u003e \u003cp\u003e12.12 Key Takeaways 247\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Advanced Concepts in Demand and Supply Planning 249\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Advanced Concepts in Demand and Supply Planning 249\u003c\/p\u003e \u003cp\u003e13.2 Accuracy or Conservatism in Demand Planning 250\u003c\/p\u003e \u003cp\u003e13.3 Aggregate Forecasting 252\u003c\/p\u003e \u003cp\u003e13.4 Forecasting Subject Attrition and Subject Replacement 253\u003c\/p\u003e \u003cp\u003e13.5 End-to-End Supply Planning Strategy 255\u003c\/p\u003e \u003cp\u003e13.6 Demand and Supply Planning for Variable Durations of Treatment 258\u003c\/p\u003e \u003cp\u003e13.7 Demand and Supply Planning for Dose Titrations, Reductions, and SKU Switches 259\u003c\/p\u003e \u003cp\u003e13.8 Demand and Supply Planning for Extensions 261\u003c\/p\u003e \u003cp\u003e13.9 Segregating Site Inventory from Depot Inventory 263\u003c\/p\u003e \u003cp\u003e13.10 Inventory Pooling 264\u003c\/p\u003e \u003cp\u003e13.11 Low-Case–High-Case Demand and Supply Planning 264\u003c\/p\u003e \u003cp\u003e13.12 Deterministic Versus Stochastic Demand and Supply Planning 268\u003c\/p\u003e \u003cp\u003e13.13 Key Takeaways 268\u003c\/p\u003e \u003cp\u003eNotes 270\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Clinical Supply Chain Reports, Budgets, and Metrics 271\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 The Importance of Communication in Supply Chain Management 271\u003c\/p\u003e \u003cp\u003e14.2 Inventory Reporting 272\u003c\/p\u003e \u003cp\u003e14.3 Visualizing the Production Plan 273\u003c\/p\u003e \u003cp\u003e14.4 Visualizing the Supply Plan and Inventory Management Strategy 275\u003c\/p\u003e \u003cp\u003e14.5 Portfolio Reports 277\u003c\/p\u003e \u003cp\u003e14.6 Translating the Supply Plan into a Budget Forecast 279\u003c\/p\u003e \u003cp\u003e14.7 Cost of Goods Analyses 282\u003c\/p\u003e \u003cp\u003e14.8 Metrics 283\u003c\/p\u003e \u003cp\u003e14.9 Dashboards 285\u003c\/p\u003e \u003cp\u003e14.10 Key Takeaways 287\u003c\/p\u003e \u003cp\u003eNotes 288\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Clinical Supply Chain Planning Processes 289\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 The Clinical Supply Chain Planning Processes 289\u003c\/p\u003e \u003cp\u003e15.2 Demand and Supply Plan Creation 290\u003c\/p\u003e \u003cp\u003e15.3 Demand and Supply Planning 293\u003c\/p\u003e \u003cp\u003e15.4 Operational Clinical Demand and Operations Planning 299\u003c\/p\u003e \u003cp\u003e15.5 Strategic Clinical Demand and Operations Planning 303\u003c\/p\u003e \u003cp\u003e15.6 Supply Plan Handover and Order Readiness 305\u003c\/p\u003e \u003cp\u003e15.7 Global Supply Execution Readiness 306\u003c\/p\u003e \u003cp\u003e15.8 Supply Network Planning 307\u003c\/p\u003e \u003cp\u003e15.9 Three Keys to Business Process Success 309\u003c\/p\u003e \u003cp\u003e15.10 Key Takeaways 310\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 A Week in the Life of a Clinical Planner 313\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Before the Week Begins 313\u003c\/p\u003e \u003cp\u003e16.2 Monday: Scenarios Incoming 314\u003c\/p\u003e \u003cp\u003e16.3 Tuesday: Study Design Scenario Planning 315\u003c\/p\u003e \u003cp\u003e16.4 Wednesday: A Lower-than-Planned Yield 318\u003c\/p\u003e \u003cp\u003e16.5 Thursday Morning: Regulatory Restrictions 321\u003c\/p\u003e \u003cp\u003e16.6 Thursday Afternoon and Friday: The Adaptive Trial Design 323\u003c\/p\u003e \u003cp\u003e16.7 Friday Afternoon: Excellence in Planning 329\u003c\/p\u003e \u003cp\u003e16.8 Key Takeaways 331\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Comparator and Ancillary Planning 333\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Comparator and Ancillary Definitions 333\u003c\/p\u003e \u003cp\u003e17.2 Regulatory Implications for IMP and Non-IMP Comparators 334\u003c\/p\u003e \u003cp\u003e17.3 Active IMP Comparator Considerations 336\u003c\/p\u003e \u003cp\u003e17.4 Additional Blinded IMP Comparator Considerations 339\u003c\/p\u003e \u003cp\u003e17.5 Non-IMP Comparator Medication Considerations 340\u003c\/p\u003e \u003cp\u003e17.6 Ancillary Supply Considerations 340\u003c\/p\u003e \u003cp\u003e17.7 Key Takeaways 343\u003c\/p\u003e \u003cp\u003eNotes 344\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Make-to-Order and Just-in-Time Supply Chains in Clinical Trials 345\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Make-to-Stock and Make-to-Order Supply Chain Management 345\u003c\/p\u003e \u003cp\u003e18.2 MTS, MTO, Lean, and JIT Supply Chain Principles 347\u003c\/p\u003e \u003cp\u003e18.3 Inventory Pooling and Just-in-Time Manufacturing 349\u003c\/p\u003e \u003cp\u003e18.4 Allogenic Cell Therapy Supply Chain Considerations 352\u003c\/p\u003e \u003cp\u003e18.5 Autologous Cell Therapy Supply Chain Considerations 354\u003c\/p\u003e \u003cp\u003e18.6 Key Takeaways 358\u003c\/p\u003e \u003cp\u003eNotes 358\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Direct-to-Patient Supply Chain Management 361\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction to Decentralized Clinical Trials 361\u003c\/p\u003e \u003cp\u003e19.2 Direct-to-Patient Supply Chain Models 362\u003c\/p\u003e \u003cp\u003e19.3 Direct-to-Patient Supply Chain Stakeholders and Costs 364\u003c\/p\u003e \u003cp\u003e19.4 Direct-to-Patient Supply Chain Planning Considerations 366\u003c\/p\u003e \u003cp\u003e19.5 The Direct-to-Patient Supply Chain Execution Process 368\u003c\/p\u003e \u003cp\u003e19.6 Other Direct-to-Patient Supply Chain Execution Considerations 370\u003c\/p\u003e \u003cp\u003e19.7 Parting Thoughts on the Direct-to-Patient Supply Chain 373\u003c\/p\u003e \u003cp\u003e19.8 Key Takeaways 373\u003c\/p\u003e \u003cp\u003eNotes 374\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Contract Organization Management and Oversight 375\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Strategic Supplier Management Within the Biopharmaceutical Industry 375\u003c\/p\u003e \u003cp\u003e20.2 Insourcing, Make-Versus-Buy, and Outsourcing 376\u003c\/p\u003e \u003cp\u003e20.3 Supplier Identification and Selection 378\u003c\/p\u003e \u003cp\u003e20.4 Supplier Qualification and Contracting 381\u003c\/p\u003e \u003cp\u003e20.5 Strategic Supplier Management 382\u003c\/p\u003e \u003cp\u003e20.6 Clinical Supply Chain Sourcing Strategies 385\u003c\/p\u003e \u003cp\u003e20.7 Contract Research Organization Engagement 386\u003c\/p\u003e \u003cp\u003e20.8 Key Takeaways 388\u003c\/p\u003e \u003cp\u003eNotes 389\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 International Logistics for Clinical Biopharmaceutical Products 391\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21.1 International Logistics for Clinical Biopharmaceutical Products 391\u003c\/p\u003e \u003cp\u003e21.2 Duties, Taxes, Valuation, and Registration 392\u003c\/p\u003e \u003cp\u003e21.3 Logistics Stakeholders and IncoTerms 394\u003c\/p\u003e \u003cp\u003e21.4 The International Shipping Business Process 396\u003c\/p\u003e \u003cp\u003e21.5 Import for Export, Free Trade Zones, and Special Economic Zones 400\u003c\/p\u003e \u003cp\u003e21.6 Key Takeaways 401\u003c\/p\u003e \u003cp\u003eNotes 402\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Clinical Supply Chain Planning Tools and Technology 403\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e22.1 Data, Technology, and Clinical Supply Chain Planning 403\u003c\/p\u003e \u003cp\u003e22.2 Demand and Supply Planning in Spreadsheets 405\u003c\/p\u003e \u003cp\u003e22.3 Data Governance 408\u003c\/p\u003e \u003cp\u003e22.4 Training 410\u003c\/p\u003e \u003cp\u003e22.5 Business Process Integration 411\u003c\/p\u003e \u003cp\u003e22.6 Beyond Spreadsheets: Selection and Implementation Strategies for Advanced Planning Systems 412\u003c\/p\u003e \u003cp\u003e22.7 The Future of Technology in Clinical Supply Chain Management 414\u003c\/p\u003e \u003cp\u003e22.8 Key Takeaways 416\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Integrating the Clinical Supply Chain into a Commercial Launch 419\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e23.1 Transitioning from Clinical Supply Chain Management to Global Supply Chain Management 419\u003c\/p\u003e \u003cp\u003e23.2 Commercial Supply Chain Strategy 420\u003c\/p\u003e \u003cp\u003e23.3 Integrating Clinical and Commercial Demand and Supply Planning 423\u003c\/p\u003e \u003cp\u003e23.4 Sales and Operations Planning as an Integrator of Clinical and Commercial Supply Chain Management 425\u003c\/p\u003e \u003cp\u003e23.5 Commercial Supply Chain Execution 427\u003c\/p\u003e \u003cp\u003e23.6 The Commercial Quality Management System and Regulatory Considerations 428\u003c\/p\u003e \u003cp\u003e23.7 The Evolution of the Global Supply Chain Organization 430\u003c\/p\u003e \u003cp\u003e23.8 Key Takeaways 431\u003c\/p\u003e \u003cp\u003eNotes 432\u003c\/p\u003e \u003cp\u003eAppendix: Clinical Supply Chain Planning Data Elements and Formulas 433\u003c\/p\u003e \u003cp\u003eGlossary 439\u003c\/p\u003e \u003cp\u003eIndex 449\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley","offers":[{"title":"Brand New","offer_id":52173731168536,"sku":"9781394179558","price":89.49,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9781394179558.jpg?v=1781168892","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/supply-chain-planning-for-clinical-trials-a-practical-guide-paperback-softback-9781394179558","provider":"Freshly Printed Books","version":"1.0","type":"link"}