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Software Innovations in Clinical Drug Development and Safety

Book Description

In light of the rising cost of healthcare and the overall challenges associated with delivering quality care to patients across regions, scientists and pharmacists are exploring new initiatives in drug discovery and design. One such initiative is the adoption of information technology and software applications to improve healthcare and pharmaceutical processes. Software Innovations in Clinical Drug Development and Safety is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing. Taking a multi-faceted approach to the application of computational methods to pharmaceutical science, this publication is ideal for healthcare professionals, pharmacists, computer scientists, researchers, and students seeking the latest information on the architecture and design of software in clinical settings, the impact of clinical technologies on business models, and the safety and privacy of patients and patient data. This timely resource features a well-rounded discussion on topics pertaining to the integration of computational methods in pharmaceutical science and practice including, the impact of software integration on business models, patient safety concerns, software architecture and design, and data security.

Table of Contents

  1. Cover
  2. Title Page
  3. Copyright Page
  4. Book Series
    1. Mission
    2. Coverage
  5. Foreword
  6. Preface
  7. Chapter 1: Overview of Clinical Trial and Pharmacovigilance Process and Areas of Application of Computer System
    1. ABSTRACT
    2. INTRODUCTION AND BACKGROUND
    3. FUTURE RESEARCH DIRECTIONS
    4. CONCLUSION
    5. REFERENCES:
    6. KEY TERMS AND DEFINITIONS
  8. Chapter 2: Data Warehouse and Data Virtualization
    1. ABSTRACT
    2. INTRODUCTION
    3. 1. DEVELOPMENT OF BUSINESS CASE
    4. 2. IDENTIFYING RIGHT RESOURCES
    5. 3. CLINICAL AND SAFETY DATA WAREHOUSE DEVELOPMENT AND MAINTENANCE
    6. ACKNOWLEDGMENT
    7. REFERENCES
    8. KEY TERMS AND DEFINITIONS
  9. Chapter 3: Application of Metadata Repository and Master Data Management in Clinical Trial and Drug Safety
    1. ABSTRACT
    2. INTRODUCTION
    3. REFERENCES
    4. KEY TERMS AND DEFINITIONS
  10. Chapter 4: Semantic Interation, Text Mining, Tools and Technologies
    1. ABSTRACT
    2. INTRODUCTION
    3. REFERENCES
    4. KEY TERMS AND DEFINITIONS
  11. Chapter 5: Safety Signal Detection in the Drug Development Process
    1. ABSTRACT
    2. INTRODUCTION
    3. BACKGROUND
    4. QUANTITATIVE SAFETY SIGNAL DETECTION
    5. QUANTITATIVE SAFETY SIGNAL DETECTION DURING DRUG DEVELOPMENT
    6. POST-MARKETING
    7. QUANTITATIVE SIGNAL DETECTION IN OTHER DATA SOURCES
    8. REFERENCES
  12. Chapter 6: Application of SMAC Technology
    1. ABSTRACT
    2. INTRODUCTION
    3. DEFINING S-M-A-C
    4. PHARMA STAKEHOLDERS’ VIEW ON SMAC TECHNOLOGY
    5. SMAC AS THE CORNERSTONE FOR INNOVATIONS IN PHARMA R&D ECOSYSTEM
    6. IMPLEMENTATION OF SMAC IN LIFE SCIENCES BUSINESSES
    7. KEY CONSIDERATIONS WHEN IMPLEMENTING SMAC IN LIFE SCIENCES BUSINESSES
    8. SUMMARY AND CONCLUSION
    9. REFERENCES
    10. APPENDIX
  13. Chapter 7: Architecture of an Integrated Collaboration Portal for Clinical Trial
    1. ABSTRACT
    2. 1. INTRODUCTION
    3. 2. INTEGRATED CLINICAL COLLABORATION PLATFORM
    4. 4. BUILDING ARCHITECTURE OF INTEGRATED CLINICAL COLLABORATION PLATFORM
    5. 5. ARCHITECTURE GOALS AND CONSTRAINTS OF INTEGRATED CLINICAL COLLABORATION PLATFORM
    6. 6. USE OF OPEN SOURCE AND COMMERCIAL CUSTOMIZED OFF THE SHELF PRODUCT / SOLUTION IN THE ARCHITECTURE
    7. HARMONIZATION OF CLINICAL COLLABORATION – PROPOSAL FOR A CONSORTIUM BASED APPROACH
    8. 7. WHAT IS AN ARCHITECTURE PATTEN?
    9. 8. KEY ARCHITECTURE PATTERNS USED FOR CLINICAL COLLABORATION PLATFORM
    10. 9. ARCHITECTURAL CONSIDERATION FOR DEPLOYMENT OF INTEGRATED CLINICAL COLLABORATION PLATFORM
    11. 10. CONCLUSION
    12. REFERENCES
    13. KEY TERMS AND DEFINITIONS
    14. APPENDIX
  14. Chapter 8: Architecture of an Integrated Regulatory Information Management Platform for Clinical Trials
    1. ABSTRACT
    2. 1.1 INTRODUCTION
    3. 1.2 ARCHITECTING AN INTEGRATED REGULATORY INFORMATION MANAGEMENT PLATFORM
    4. 1.3 DEEP-DIVE INTO THE IMPLEMENTATION OF INTEGRATED REGULATORY INFORMATION MANAGEMENT PLATFORM
    5. 1.4 ARCHITECTURE GOALS AND CONSIDERATIONS OF THE RIM PLATFORM
    6. 1.5 USE OF OPEN SOURCE AND COMMERCIAL CUSTOMIZED OFF THE SHELF PRODUCT/SOLUTIONS
    7. 1.6 ARCHITECTURAL PATTERNS APPLIED IN RIM PLATFORM
    8. 1.7 LOGICAL ARCHITECTURE OF RIM PLATFORM
    9. 1.8 TECHNICAL ARCHITECTURE
    10. 1.9 EXECUTION STRATEGY
    11. 1.10 CONCLUSION
    12. ACKNOWLEDGMENT
    13. REFERENCES
    14. KEY TERMS AND DEFINITIONS
    15. APPENDIX
  15. Chapter 9: Personal Diagnostics Using DNA-Sequencing
    1. ABSTRACT
    2. INTRODUCTION
    3. BACKGROUND
    4. MAIN FOCUS OF THE CHAPTER
    5. FUTURE DISCUSSION AND CONCLUSION
    6. REFERENCES
    7. KEY TERMS AND DEFINITIONS
  16. Chapter 10: Pharmacogenomics Genome Wise Association Clinical Studies
    1. ABSTRACT
    2. INTRODUCTION
    3. BACKGROUND
    4. MAIN FOCUS OF THE CHAPTER
    5. Issues and Suggested Recommendations
    6. FUTURE DISCUSSION AND CONCLUSION
    7. REFERENCES
    8. KEY TERMS AND DEFINITIONS
  17. Chapter 11: Role of Epigenetics in Cancer Genomics
    1. ABSTRACT
    2. INTRODUCTION
    3. BACKGROUND
    4. MAIN FOCUS OF THE CHAPTER
    5. ChIP-seq DATA ANALYSIS
    6. FUTURE DISCUSSION AND CONCLUSION
    7. REFERENCES
    8. KEY TERMS AND DEFINITIONS
  18. Chapter 12: Impact of Human Exome Sequencing on Clinical Research
    1. ABSTRACT
    2. INTRODUCTION
    3. A PARADIGM SHIFT IN CLINICAL RESEARCH
    4. EXOME SEQUENCING AS A TOOL FOR CLINICAL RESEARCH
    5. DATABASES AND UTILITIES
    6. CONCLUSION
    7. REFERENCES
    8. KEY TERMS AND DEFINITIONS
  19. Chapter 13: Agile Methodology of Development and How to be Compliant
    1. ABSTRACT
    2. INTRODUCTION
    3. PROCESS COMPLIANCE
    4. CONCLUSION
    5. REFERENCES
    6. ADDITIONAL READING
    7. KEY TERMS AND DEFINITIONS
  20. Compilation of References
  21. About the Contributors