NEW YORK, Oct. 18, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Central and Core Laboratories 2011
http://www.reportlinker.com/p0656763/Central-and-Core-Laboratories-2011.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic
Central and Core Laboratories
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 $2.2 billion a year and is vital to the successful development of new drugs. It is a completely outsourced and 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 gives comprehensive coverage of 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
• Analysis of Costs
• Financial and Value Analysis
• Logistics
• Review of Leading Companies
• Regulatory and QA Issues
• Biomarkers and Central Labs
• ECG Laboratories
• Imaging Laboratories
• Future Trends and Challenges
The comprehensively-referenced report is published by Biopharm Knowledge Publishing and is edited by Dr Graham Hughes, one of the leading experts on pharmaceutical outsourcing.
Contributors include:
Dr Graham Hughes
Richard Barrett
David Cockburn
Dr Colin Miller
Tim Stiles
This 250-page report provides a full picture of a fast-growing industry now worth more than $2 billion and vital to the success of drug development. It also gives a complete guide to managing the outsourcing and logistics process.
Central and Core Laboratories
Contents
Abbreviations & Glossary
Preface
Editors and Contributors
Introduction
Chapter 1
Overview of Central Clinical Laboratories Capabilities & Facilities
By Richard Barrett
1. Data Production
2. Laboratory Information System (LIMs)
2.1 Protocol
2.2 Analytical Plan
2.3 Kit Manufacture
2.4 Shipments of Kits to Investigator Site
2.5 Sample Collection
2.6 Sample Transport
2.7 Sample Reception
2.8 Sample Analysis
2.9 Reflex Testing
2.10 Data Reporting
2.11 Abnormal Data Reporting
2.12 Data Transfer Protocols
3. Facilities & Equipment
3.1 Facilities
3.2 Equipment
3.3 Data Interpretation
3.4 Archiving
3.5 Help Desk
4. Last Word
Chapter 2
The Role of Central Laboratories in Clinical Trials
By Richard Barrett
1. Introduction
2. Clinical Trial Design
2.1 Phase I
2.2 Phase II and III
2.3 Phase IV – Post Market Surveillance
3. Laboratory Analysis in Clinical Trial Design
4. Protocol Design
4.1 Inclusion / Exclusion Criteria
4.2 Safety & Efficacy
4.3 Measurement
5. Reporting Requirements
5.1 Drug Induced Liver Injury
5.2 Renal Biomarkers
6. Practical Considerations in Assessing the Causality of Abnormal Data
7. Serious Adverse Events and Laboratory Data
Chapter 3
History of Pathology
By Graham Hughes
Chapter 4
A Brief Overview of the History of Central Laboratories
By Graham Hughes, Richard Barrett & David Cocker
Chapter 5
Contracting Considerations
By Richard Barrett
1. Introduction
2. Criteria For Central Laboratory Selection
2.1 Patient Population
2.2 Track Record
2.3 Ownership
2.4 Experience
2.5 Number of Clients
3. Financial Information
3.1 Costs
3.2 Turnover
3.3 Financial Audit
4. Analytical Capabilities
4.1 In-house Analytical Capability
4.2 Capacity
4.3 Instrument Age, Replacement Strategy & Back-up
4.4 Method Evaluation
4.5 Sub Contracting Arrangements
5. Geographic Coverage
5.1 Location
5.2 Coverage
6. Service
6.1 Study Management
6.2 Kit Production
6.3 Investigator Instructions
6.4 Courier Arrangements & Sample Tracking
6.5 Turn Around Time
6.6 Language Capability
6.7 Emergency Procedure
7. Science
7.1 Appropriateness & Maintenance of Equipment
7.2 Methodology
7.3 Reference Ranges & Panic Values
7.4 Qualification of Staff
7.5 Staff Turnover
7.6 Quality Control
8. Quality Assurance
8.1 GCLP Compliance
8.2 CAP/CPA/ISO Accreditation
8.3 Inspection History
9. Data Management
9.1 Validated IT System Inc 21 CFR Part 11
9.2 Project ID
9.3 Sample ID
9.4 Reporting
9.5 Electronic Data Transfer
9.6 Access to Data
10. Flexibility
11. Communication
12. How to Contract
12.1 Study
12.2 RFI
12.3 RFP
12.4 Audit
12.5 Bid Defence
12.6 Contract or Master Service Agreement / Work Order
12.7 Review
12.8 Study Close Out
13. Essentials of a Contract
14. Terms and Conditions
15. Project Specific - Laboratory Protocol
15.1 Price Build Up
15.2 Communication
15.3 Task Ownership Matrix (TOM)
16. Negotiation
16.1 Basis
16.2 Understanding the Price Build Up
16.3 Volume
17. Last Word
Chapter 6
Analysis of Laboratory Costs
By Richard Barrett
1. Introduction
2. Administration
3. Study Management
4. Kit Production
5. Client Liaison
6. Archiving
7. Help Desk
8. General Administration
9. Phlebotomy – Blood Taking
10. Transport
11. Analysis Costs / Reflex Testing
12. Database Set Up and Management
13. Data Management
14. Profit
15. Derivation of Costs
15.1 Labour Rate
15.2 Overheads
15.3 Derivation of Unit Costs
15.4 Pass Through Costs
16. Last Word
Chapter 7
How Can CROs and Central Laboratories Increase the Value of Projects – A Financial Analysis
By Graham Hughes
1. Introduction
2. A Definition of Value
3. The Development Scenario
4. Calculations of Net Present Value
5. Conclusions & Recommendation
Chapter 8
The Central Laboratory Market
By Graham Hughes
1. Introduction
2. Calculation of Market Size
3. Growth of Central Laboratories
4. Geographical Distribution
Chapter 9
Clinical Logistics & Its Role in Central Laboratories Operations
By David Cocker
1. Background
2. Strategic Position of Central Laboratory and Courier
3. The Role of the Courier in Stratified Studies
4. Selecting a Central Laboratory with Logistics in Mind
4.1 Organisation and Company Ethos
4.2 Shipping Conditions
4.3 Sample Selection Kit
4.4 Track Record and Metrics
4.5 Flexibility
4.6 Medical Supervision & Knowledge
5. Pre-Analytical Changes
6. Optimising 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. Shipping Cost Control
11. Costs
12. Conclusion
Chapter 10
Biomarkers and Central Laboratories
By David Cockburn
1. Introduction
2. Availability of Biomarkers
2.1 Surrogacy
2.2 Sample Matrix
2.3 Flow Cytometry
2.4 Immunohistochemistry
2.5 Circulating Free DNA and Tumour Cells
3. Definitions of Quality
4. Economics of Assay Availability
5. Economics of Globalisation
6. Examples of Biomarker Use
Chapter 11
Review of Leading Companies
By Graham Hughes & Marianne O'Neill
1. BARC
2. BioReliance Invitrogen Bioservices
3. Bioscientia
4. Celerion
5. Cirion Clinical Trial Services Inc
6. Covance
7. Eurofins Global Central Laboratory
8. INTERLAB Central Lab Services – Worldwide GmbH
9. INVITRO
10. Laboratorio Dr Echevarne Analisis SA
11. LabConnect LLC
12. Laboratoire Biomnis
13. Laboratorio Hidalgo
14. Labor Dr Spranger & Partner (Spranger Laboratories)
15. LBM - Laboratorio Bioquima Medica SRL
16. Medpace Reference Laboratory
17. Mitsubishi Chemical Medience Corporation
18. Protech Pharmaservices Corporation
19. Quest Diagnostics Clinical Trials
20. Quintiles Laboratories Ltd
21. Simbec Research Ltd
22. SIPLAS Central Laboratory
23. Synevo Central Lab
24. TDL Clinical Trials
25. Unilabs York Bioanalytical Services
26. Wickham Laboratories Ltd
Chapter 12
Regulatory & QA Issues
By Tim Stiles – Qualogy Ltd
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 (EMA)
4. USA and Japan
5. Other Countries
6. Regulatory Summary
7. Good Clinical Laboratory Practice (GCLP)
7.1 Introduction
7.2 Scope
7.3 Good Laboratory Practice (GLP)
7.4 Good Clinical Laboratory Practice (GCLP)
7.5 Quality Audit
7.6 Proficiency Schemes
7.7 Trial Sponsors
7.8 Accreditation
7.9 National Clinical Requirements
8. Conclusion
Chapter 13
Central ECG Laboratories
By John Blakeley
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 14
Central Imaging Core Laboratories
By Dr Colin G Miller
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 15
CDISC
By Paul Herd
Chapter 16
Metrics Champion Consortium
By Guy Mascaro
Chapter 17
Future Trends & Challenges
By Graham Hughes & Richard Barrett
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
Tables, Figures & Graphs
Chapter 1
Central Laboratories Capabilities & Facilities
Figure 1: Process of Data Production
Table 1: Major Instrument Manufacturers
Table 2: Standard Clinical Chemistry Safety Profile
Table 3: Standard Haematology Profile
Chapter 2
The Role of Central Laboratories in Clinical Trials
Table 1: Summary of the Populations & Purposes of Trials at Different Phases
Chapter 5
Contracting Considerations
Table 1: Laboratory Selection Criteria
Chapter 6
Analysis of Laboratory Costs
Figure 1: Breakdown of Laboratory Costs
Chapter 7
How Can CROs and Central Laboratories Increase the Value of Projects – A Financial Analysis
Graph: Net Present Value
Table 1: Calculations of Net Present Value
Table 2:
Table 3:
Chapter 8
The Central Laboratory Market
Figure 1: Types of Central Laboratories
Figure 2: Type of Company
Figure 3: Growth of Central Laboratories
Figure 4: Cumulative Growth
Figure 5: Geographical Distribution
Chapter 9
Clinical Logistics & Its Role in Central Laboratories Operations
Table 1: Classes of Couriers
Figure 1: Specimen Management: High Level Process
To order this report:
In Vitro Diagnostic Industry: Central and Core Laboratories 2011
In Vitro Diagnostic Business News
Check our Industry Analysis and Insights
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
Share this article