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E-BOOK
Title Global Clinical Trials Playbook : Management and Implementation when resources are limited.
Imprint Burlington : Elsevier Science, 2012.

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Description 1 online resource (332 pages)
Note Specifics of randomized controlled trials in alzheimer's disease.
Available only to authorized UTEP users.
Print version record.
Subject Clinical trials -- Handbooks, manuals, etc.
Human experimentation in medicine -- Handbooks, manuals, etc.
Genre Handbooks and manuals.
Contents Front Cover; Dedication; Global Clinical Trials Playbook: Capacity and CapabilityBuilding; Copyright; Contents; International Editorial Advisors; Capacity Building for Global Clinical Trials; Contributors; Section 1 -- Clinical Trials; Chapter 1 -- Introduction; Chapter 2 -- Global Clinical Trials: Study Design and Planning; INTRODUCTION; PRINCIPLES OF CLINICAL STUDY DESIGN; Reference; Chapter 3 -- Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials: African Perspectives; INTRODUCTION; STATUS OF CLINICAL TRIALS IN AFRICA; SITE MANAGEMENT STRUCTURES.
CURRENT FUNDING MODELS AND IMPACT ON IMPLEMENTATION OF STUDIESBUILDING ADDITIONAL CAPACITY; ESTABLISHING NEW SITES; References; Chapter 4 -- Clinical Trial Sites Capabilities: Standard Operating Procedure Implementation in Effective African Models; INTRODUCTION; ROLE OF STANDARD OPERATING PROCEDURES IN CLINICAL RESEARCH; STANDARD OPERATING PROCEDURES, POLICIES, GUIDELINES, AND STUDY-SPECIFIC PROCEDURES; SUGGESTED LIST OF STANDARD OPERATING PROCEDURES; LOGISTICS ASSOCIATED WITH STANDARD OPERATING PROCEDURE IMPLEMENTATION; CONCLUSION; References.
Chapter 5 -- How to Select and Oversee Contract Research OrganizationsINTRODUCTION; PERSPECTIVE OF WORKING WITH GLOBAL AND NICHE CONTRACT RESEARCH ORGANIZATIONS; UNDERSTANDING YOUR OPTIONS WHEN OUTSOURCING AN OVERSEAS TRIAL; COMPARING THE CAPABILITIES OF GLOBAL AND NICHE CONTRACT RESEARCH ORGANIZATIONS TO SUPPORT CLINICAL TRIALS; ASSESSING THE BENEFITS OF INTERNATIONAL REACH VERSUS LOCAL KNOWLEDGE; EXAMINING QUALITY AND RELATIONSHIP MANAGEMENT TO FINALIZE CONTRACT RESEARCH ORGANIZATION SELECTION; References.
Chapter 6 -- The How-To of Global Clinical Trial Forecasting, Budgeting, and Project ManagementRECENT TRENDS IN CLINICAL TRIALS; CLINICAL TRIAL FORECASTING; CLINICAL TRIAL BUDGETING; CLINICAL TRIAL PROJECT MANAGEMENT; References; Section 2 -- Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets; Chapter 7 -- Lessons Learned in India; INTRODUCTION; INDIA'S HEALTHCARE SYSTEM; INDIA'S CLINICAL TRIALS SECTOR; ECCRO'S APPROACH TO SITE DEVELOPMENT AND SUPPORT IN INDIA; References; Chapter 8 -- Lessons Learned in China; INTRODUCTION.
ADVANTAGES OF CONDUCTING CLINICAL TRIALS IN CHINACHALLENGES TO CONDUCTING GLOBAL CLINICAL TRIALS IN CHINA; REGULATORY APPROVAL; HOW CAN CHINA PARTICIPATE IN GLOBAL MULTICENTER TRIALS?; SOME PRACTICAL ASPECTS OF GLOBAL STUDIES IN CHINA; COST OF CLINICAL TRIALS IN CHINA; CLINICAL TRIAL MONITORING IN CHINA; CLINICAL TRIALS OUTSOURCING IN CHINA; INTELLECTUAL PROPERTY RIGHTS; SUMMARY; Acknowledgments; References; Chapter 9 -- Lessons Learned in Eastern Europe; INTRODUCTION; CONTRACTING; ROLE OF THE HEAD OF THE DEPARTMENT; SITE SELECTION.
Summary Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices€to market. Because of timeline pressures and cost as well as€the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, €regulatory professionals, safety.
Other Author Chin, Richard.
Other Title Print version: Bairu, Menghis. Global Clinical Trials Playbook : Management and Implementation when resources are limited. Burlington : Elsevier Science, ©2012 9780124157873