Central and Core Laboratories

Publication Date	October 2007
Publisher	Biopharm Knowledge
Product Type	Report
Pages	280
ISBN Number	not applicable
Product Code	BKP00006

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£995.00
approximately: $1,859 | €1,262

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Summary

A definitive report on the current status and future prospects of Central Clinical Pathology Laboratories, Central ECG Analysis Laboratories and Central Bio-imaging Laboratories.

The Central and Core Laboratories market is now worth more than $1.5 billion a year and is vital to the successful development of new drugs. It is a truly global business dominated by major players.

Choosing the right Central Laboratory and handling the relationship effectively is vital to the successful management of clinical trials, as is the complex business of getting samples from the patient to the laboratory.

In a publishing breakthrough this 250 page report - updated October 2007 - gives comprehensive cover the Central Laboratories market, the major companies involved, the processes, including testing and logistics and the future challenges for the market. It is a vital resource for anyone involved in drug development, clinical trials, the central labs market and logistics.

Contents include:

Overview of capabilities and facilities
Role of Central Labs in clinical trials
History of the Central Labs business
Contract Considerations
Review of the current market
Logistics
Review of leading companies
Regulatory and QA issues
ECG laboratories
Imaging laboratories
Future trends and challenges

The comprehensively-referenced report is published by Biopharm Knowledge Publishing, Part of the Technomark Group and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing and one of the founders of Technomark. Contributors include:

Dr Graham Hughes
Richard Barrett
David J. Cocker
Eileen Daniel
Dr Colin Miller
Tim Stiles

This 250 page report provides a full picture of a fast-growing industry now worth more than $1 billion and vital to the success of drug development. It also gives a complete guide to managing the outsourcing and logistics process.

Content

Chapter 1 Overview of Central Clinical Laboratories Capabilities & Facilities
- 1. Introduction
- 2. Apparatus
- 3. Data Handling
  - 3.1 Protocol
  - 3.2 Analytical Plan
  - 3.3 Kit Manufacture
  - 3.4 Shipments of Kits to Investigator Site
  - 3.5 Sample Collection
  - 3.6 Sample Transport
  - 3.7 Sample Reception
  - 3.8 Sample Analysis
  - 3.9 Reflex Testing
  - 3.10 Data Reporting
  - 3.11 Abnormal Data Reporting
  - 3.12 Data Transfer Protocols
  - 3.13 Data Interpretation
  - 3.14 Archiving
- 4. Courier Liaison
Chapter 2 Role of Central Laboratories in Clinical Trials
- 1. Introduction
- 2. Definition of Clinical Trials
- 3. The Four Phases of Clinical Trials
  - 3.1 Phase I
  - 3.2 Phase II
  - 3.3 Phase III
  - 3.4 Phase IV
- 4. Clinical Program Design
- 5. Clinical Trial Design
- 6. Protocol
  - 6.1 Inclusion / Exclusion Criteria
  - 6.2 Safety & Efficacy
  - 6.3 Measurement
- 7. Reporting
Chapter 3 History of Pathology
Chapter 4 Contracting Considerations
- 1. Introduction
- 2. Patient Population
- 3. Track Record
  - 3.1 Ownership
  - 3.2 Length of Time in Business
  - 3.3 Number of Clients
- 4. Financial Information
  - 4.1 Costs
  - 4.2 Turnover
  - 4.3 Financial Stability
- 5. Analytical Capabilities
  - 5.1 In-house Analytical Capability
  - 5.2 Capacity
  - 5.3 Instrument Age, Replacement Strategy & Back-up
  - 5.4 Method Evaluation
  - 5.5 Sub Contracting Arrangements
- 6. Geographic Coverage
  - 6.1 Location
  - 6.2 Coverage
- 7. Service
  - 7.1 Study Management
  - 7.2 Kit Production
  - 7.3 Investigator Instructions
  - 7.4 Courier Arrangements & Sample Tracking
  - 7.5 Turn Around Time
  - 7.6 Language Capability
  - 7.7 Emergency Procedure
- 8. Science
  - 8.1 Appropriateness & Maintenance of Equipment
  - 8.2 Methodology
  - 8.3 Reference Ranges & Panic Values
  - 8.4 Qualification of Staff
  - 8.5 Staff Turnover
  - 8.6 Quality Control
- 9. Quality Assurance
  - 9.1 GCLP Compliance
  - 9.2 CAP/CPA/ISO Accreditation
  - 9.3 Inspection History
- 10. Data Management
  - 10.1 Validated IT System Inc 21 CFR Part 11
  - 10.2 Project ID
  - 10.3 Sample ID
  - 10.4 Reporting
  - 10.5 Electronic Data Transfer
  - 10.6 Access to Data
- 11. Flexibility
- 12. Communication
- 13. How to Contract
  - 13.1 Study
  - 13.2 RFI
  - 13.3 RFP
  - 13.4 Audit
  - 13.5 Bid Defence
  - 13.6 Contract or Master Service Agreement / Work Order
  - 13.7 Review
  - 13.8 Study Close Out
- 14. Essentials of a Contract
- 15. Terms and Conditions
- 16. Laboratory Protocol
  - 16.1 Price Build Up
  - 16.2 Communication
  - 16.3 Task Ownership Matrix (TOM)
- 17. Negotiation
  - 17.1 Basis
  - 17.2 Understanding the Price Build Up
  - 17.3 Volume
Chapter 5 The Central Laboratory Market
- 1. Introduction
- 2. Calculation of Market Size
- 3. Growth of Central Laboratories
- 4. Geographical Distribution
Chapter 6 Clinical Logistics & Its Role in Central Laboratories Operations
- 1. Background
- 2. Clinical Protocol to Project Deliverable
- 3. Evolution of Central Laboratories in the 80's and 90's
- 4. Research and Development Structures
- 5. Selecting a Central Laboratory with Logistics in Mind
  - 5.1 Organisation
  - 5.2 Company Ethos
  - 5.3 Track Record & Endorsements
  - 5.4 Logistics
  - 5.5 Procedures
  - 5.6 Accreditation
  - 5.7 Flexibility
  - 5.8 Medical Supervision & Knowledge
- 6. Optimizing Logistics
- 7. Regulatory Environment
- 8. Packaging Regulations
- 9. Shipping Regulations
  - 9.1 Basic Checklist For Dangerous Goods (UN 2814)
  - 9.2 Diagnostic Specimens (Clinical Specimens): UN 3373
- 10. Costs
- 11. Electronic Enhancement of Logistics
- 12. Convergence of Logistic Needs
- 13. Conclusion
Chapter 7 Review of Leading Companies
- 1. ACM Pivotal Global Central Laboratory
- 2. BARC
- 3. BioReliance Corporation
- 4. Bioscientia - Institut fr medizinische Diagnostik GmbH
- 5. Capio Diagnostik a. s.
- 6. CentraLabS Ltd
- 7. Charles River
- 8. Cirion Clinical Trial Services Inc
- 9. Covance
- 10. CRL Medinet Europe
- 11. Esoterix Clinical Trials Services
- 12. Eurofins Medinet
- 13. Fleury SA
- 14. ICON Laboratories
- 15. INTERLAB Central Lab Services - Worldwide GmbH
- 16. LabConnect LLC
- 17. Laboratoire Marcel Mrieux
- 18. Laboratorio Dr Echevarne Analisis SA
- 19. LBM - Laboratorio Bioquima Medica SRL
- 20. Mayo Clinical Trial Services Central Laboratory
- 21. MDS Pharma Services
- 22. PPD Global Central Laboratories LLC
- 23. Quest Diagnostics Clinical Trials
- 24. Quintiles Laboratories Ltd
- 25. Simbec Research Ltd
- 26. Southern Research Institute
- 27. SydPath Central Laboratory
- 28. TDL Trials
- 29. Wickham Laboratories Limited
Chapter 8 Regulatory & QA Issues
- 1. Background to Current Regulations
- 2. Regulatory Scene
  - 2.1 Directive 2001/20/EC Clinical Trials Directive
  - 2.2 Directive 2005/28/EC Good Clinical Practice Directive
- 3. European Medicines Agency (EMEA)
- 4. USA & Japan
- 5. Other Countries
- 6. Regulatory Summary
- 7. Good Clinical Laboratory Practices (GCLP)
  - 7.1 Introduction
  - 7.2 Scope
  - 7.3 Good Laboratory Practice (GLP)
  - 7.4 Good Clinical Laboratory Practice (GCLP)
  - 7.5 Quality Assurance
  - 7.6 Proficiency Schemes
  - 7.7 Trial Sponsors
  - 7.8 Accreditation
  - 7.9 National Clinical Requirements
- 8. Conclusion
Chapter 9 Central ECG Laboratories
- 1. Introduction
- 2. ECG Fundamentals
- 3. The ECG in Clinical Research
- 4. The ECG Laboratory
  - 4.1 Background
  - 4.2 Clinical Trials
- 5. Central ECG Laboratory Operations
  - 5.1 ECG Integrity
  - 5.2 Routine ECG Processing
  - 5.3 Qualitative ECG Services
- 6. Central ECG Laboratory Equipment & Technology
  - 6.1 ECG Devices
- 7. ECG Management Systems
- 8. Regulation
- 9. Service Differentiation - Late Phase Clinical Trials
- 10. Service Differentiation - Early Phase Clinical Trials
  - 10.1 Rationale
  - 10.2 Site Considerations
  - 10.3 Thorough Qt (TQT) Studies or Definitive Qt (DQT) Studies
- 11. Interval Measurement & Interpretation
  - 11.1 Assignment of a Single Reader
- 12. Other Specialized Services
  - 12.1 Holter Monitoring
  - 12.2 Discrete ECGs From Holter Monitoring
  - 12.3 Endpoint Management
  - 12.4 Echocardiograms, Event Monitoring & Other Tests
- 13. People in the ECG Laboratory
  - 13.1 Project Manager
  - 13.2 ECG & Holter Technicians
  - 13.3 Data Manager
  - 13.4 Reader
- 14. FDA Digital Submission Requirements
- 15. The Landscape
- 16. Market Sizing
- 17. Customer Segmentation
- 18. The Future
- 19. Drivers of Change
- 20. Summary
Chapter 10 Central Imaging Core Laboratories
- 1. History
- 2. Description of their Operations
- 3. State-of-the-Art Technology
- 4. Regulatory Background
- 5. Imaging Core Laboratories
- 6. Financial Market Size
- 7. Imaging Technology
- 8. Considerations in Selecting an Imaging Core Laboratory
- 9. References
- Chapter 11 Future Trends & Challenges
- 1. Biologics & Biopharmaceutics
- 2. LIMS & Data Collection
- 3. CDISC
- 4. Regulatory & Quality Issues
- 5. The FDA Critical Path Initiative (CPI)
- 6. ICH E2E Pharmacovigilance Planning
  - 6.1 Background
- 7. Limitations of the Human Safety Database
- 8. Pharmacovigilance Plan
- 9. Genomics
- 10. Proteomics
- 11. Metabolomics
- 12. Key Applications
- 13. Biomarkers
- 14. Point of Care Testing
- 15. Lab-on-a-Chip (LOC)
- 16. Esoteric Testing
- 17. The Impact of the Internet
- 18. Cost Pressures
- 19. Offshoring Drug Development
- 20. The Future of the Central Laboratory Business
Appendices
- Appendix A - Master Service Agreement
- Appendix B - Generic Work Order
- Appendix C - Lab Protocol
- Appendix D - Lab Price Build Up
- Appendix E - Useful Websites
- Appendix F - List of Central Laboratories XI