{ "item_title" : "Operational Excellence in Clinical Research", "item_author" : [" Elif Delen "], "item_description" : "Operational Excellence in Clinical Research: Beyond the Protocol In clinical trials, you pay for training once, but you pay for an operational error forever. This comprehensive, 26-chapter manual is designed to transform Site Coordinators (SCs) and Clinical Research Associates (CRAs) from checklist followers into Process Architects. Written by a medical biochemist and industry expert, this guide bridges the gap where complex theoretical design hits the pavement of real-world field reality. Whether you are an experienced professional seeking technical depth or a newcomer establishing your foothold, this book provides the ultimate operational roadmap. Inside this comprehensive manual, you will find Regulatory Deep Dives: ICH-GCP revisions (R1, R2, R3), FDA & EMA standards, and core ethical foundations Methodological Perfection: Comprehensive insights into clinical study designs, randomization hierarchies, blinding engineering, and minimization algorithms. Practical Field Manuals: A complete 90-day execution timeline for Site Coordinators, advanced Informed Consent Form (ICF) management, and ALCOA-C data integrity principles. Technical Logistics & Biochemistry: Investigational Product (IP) accountability, cold chain integrity, laboratory operations, and international IATA biological sample transport regulations Audit & Inspection Mastery: Front-room/back-room dynamics, continuous inspection readiness strategies, and proactive CAPA (Corrective and Preventive Action) modeling. Interactive Learning: Dozens of field-ready checklists, an extensive clinical glossary, and standard solution algorithms. Master the details no one else sees, minimize the invisible costs of operational errors, and establish a zero-defect quality culture at your site. Elevate your career from a standard coordinator to a definitive Field Leader.", "item_img_path" : "https://covers2.booksamillion.com/covers/bam/9/79/818/036/9798180363497_b.jpg", "price_data" : { "retail_price" : "70.00", "online_price" : "70.00", "our_price" : "70.00", "club_price" : "70.00", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }

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