Outsourcing in Drug Development: The Contract Research (CRO) Market, 2nd Edition

Best Price Guarantee	Length	Publisher	Published Date	SKU
from $3,500	284 Pages	Kalorama Information	May, 2006	KLI1190862

Best Price Guarantee
Price	from $3,500
Length	284 Pages
Publisher	Kalorama Information
Published Date	May, 2006
SKU	KLI1190862

CRO is a need-to know practice in pharmaceutical marketing today; but information is not always easy to find. This second edition of Kalorama’s best-selling look at the clinical contract research industry provides the key information competitors need to navigate the complexities and costs of clinical research in the drug development process. In addition to a comprehensive discussion of the market and regulatory environment, the report details:

the size and nature of the drug research pipeline,
the size and growth of R&D spending in- and out-of-house,
the size of the CRO market by phase and by player type (CROs, academic centers, analytical laboratories, and SMOs), and
provides market share information on the leading players.

chapter one: Executive Summary

The Drug Development Process
Government Regulation of Clinical research
Clinical Trials Operations
- Government Sponsored Clinical Trials
- Private Sector Sponsored Clinical Trials
- Designing Clinical Trials
- Major Elements of Clinical Trials
- Active Phase I, II & III Clinical Trials
- Phase IV Studies: Post Approval
- Recruiting for Clinical Trials
- Electronic Data Capture and Electronic Data Management
Competing in the Contract Drug Development Industry
- Academic Medical Centers and Teaching Hospitals
- Contract Research Organizations
- Preclinical and Clinical Laboratories
- Site Management Organizations
- Niche Service Providers
- Electronic Technology Solutions
- Internet Patient Recruiting
- Clinical Trials Packaging
Contract Drug Development Market
- Contract Drug Development Competitors and Market

chapter two: Introduction to Drug Development

Drug Development Process
Government Regulation of Clinical Research
- Center for Biological Evaluation and Review
- Center for Drug Evaluation and Research
- Investigational Review Board
- Preclinical Research
- In Vitro and In Vivo Testing Process
- Investigational New Drug Application
Clinical Trials
- Preclinical Phase
- Phase I
- Phase IIa
- Phase IIb
- Phase III
- Phase IIIa
- Phase IIIb
- Phase IV: Post Approval
New Drug Application
- New Molecular Entities and Approval Time
- Significant New Products Approved in 2004
Fast Track, Priority Review, and Accelerated Approval
- Fast Track Approval
- Average Approval Time for Fast Track Designated Drugs
- Priority Review
- Accelerated Approval
- Does Speeding the Approval Process Lead to an Increase in Drugs Withdrawn from Market?
FDA Initiative to Improve Research and Review Process
FDA’s Critical Path Report
- Exploratory IND Studies— An Approach to Complying with CGMP
- INDs—Approaches to Complying with CGMP During Phase 1
- Biotechnology Industry Endorses FDA’s Critical Path

chapter three: Clinical Trials Operations

Conducting Clinical Trails
Organizations Conducting Clinical trials
- Government Sponsored Clinical Trials
- Private Sector-Sponsored Clinical Trials
- Contract Research Organizations (CROs)
- Site Management Organizations (SMOs)
Designing Clinical Trials
Major Elements of Clinical Trials
- Protocol
- Eligibility Criteria
- Endpoints
- Randomization
- Stratification
- Blinding
- Data Collection and Management Tools
- Statistical Interpretation
Active Phase I, II & III Clinical Trials
Phase IV Studies: Post Approval
- Post Approval Commitments
Recruiting for Clinical Trials
- Recruiting Costs
- Mass Media Recruitment Promotion
- Recruiting Principal Investigators
- Physician as Principal Investigator
- Recruiting Patients
- Factors Influencing Participation in Clinical Trials
- Clinical Trial Metrics
- Participant Retention
- Number of Sites per Phase; Number of Patients per Phase
- eRecruitment: Internet-Enabled Recruitment
Informed Consent Process
Demographics and Clinical Trials
- Ethnicity and Gender in Clinical Trials
Electronic Data Capture and Electronic Data Management
- Traditional Paper-Based Case Report Forms
- Advantages of EDC
- Current Assessment of EDC Adoption
- Need for an EDC Standard
- FDA Encourages EDC Systems
- Electronic Patient Diaries

chapter four: Competing in the Contract Drug Development Industry

Drug Development Costs
Outsourcing Drug Development
- A Brief History of Contract Research Outsourcing
- Focus Shifts in Outsourced Clinical Research Operations
Factors Driving Contract Research Strategy
- Cost Reduction Strategy
- Increasing Number of New Chemical Entities (NCEs) in Pipeline
- Time to Market Pressures
- Growing Complexity of Regulatory Requirements
- Rapid Access to Patient Recruiting
Contract Research Competitors
- Academic Medical Centers and Teaching Hospitals
- Contract Research Organizations
- CRO Contracts
- Competing Factors
- Preclinical and Clinical Laboratory Services
- Competing Factors
- Site Management Organizations
Clinical Trials as a Business Opportunity
- Community Physicians
- Electronic Technology Solutions
- Internet Patient/Investigator Recruiting
- Clinical Trials Packaging
- Effective Packaging Promotes Patient Compliance

chapter five: Contract Drug Development Market

Trends in Drug Development Spending
Pharmaceutical Companies: R&D Spending
Biopharmaceutical Companies: R&D Spending
Clinical Research Projects in Development
Contract Drug Development Market
- Phase I Spending Outpaces Phase II/III Trials
- Phase IIIb/IV Trial Spending Increasing
Contract Drug Development Competitors and Market
CROs Dominate Outsourced Drug Development Market
- Leading CROs’ Market Share
- CROs Broaden Services through Acquisitions
AMCs Market Share Stabilizing
- Growth of Academic Clinical Reseach Organizations
SMOs See Modest Gains
- SMOs in Transition
- Transitioning from SMO to CRO
Niche Competitors Gain Market Share
- Central Laboratories
- EDC Competitors Positioned for Big Gains
- Regulatory Agencies Driving Adoption of EDC
- EDC Market Estimates
Trends Affecting Growth in Contract Drug Development Industry
- Globalization of Drug Development
- Rapid Technological Change Increasing Data
- Biotechnology Industry Growth
- Increased Regulatory Scrutiny
- Need for Fast, Efficient, and Cost-Effective Drug Development

chapter six: Company Profiles

Contract Research Organizations
- Charles River Laboratories International, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Preclinical Services
  - Clinical Services
  - Financial Information
- Covalent Group, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Clinical Trial Services
  - Data Management Services
  - Biostatistics
  - Automated Database System
  - Financial Information
- Covance, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Preclinical Services
  - Phase I Clinical Services
  - Central Laboratory Services
  - Clinical Development Services
  - Commercialization Services
  - Financial Information
- ICON Clinical Research
  - History and Lines of Business
  - Drug Development Services
  - Financial Information
- Kendle International, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Clinical Development (Phases I to III)
  - Regulatory Affairs
  - Biometrics
  - Late Phase
  - Financial Information
- MDS Pharma Services
  - History and Lines of Business
  - Drug Development Services
  - Early Stage Development
  - Metabolism Resource
  - Early Clinical Research
  - Late Stage Development
  - Global Clinical Development
  - Financial Information
- Omnicare Clinical Research
  - History and Lines of Business
  - Drug Development Services
  - Financial Information
- Parexel International Corporation
  - History and Lines of Business
  - Drug Development Services
  - Clinical Development Services
  - Consulting Services
  - Medical Marketing Services
  - Advanced Technology
  - Publications
  - Financial Information
- Pharmaceutical Product Development, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Phase I Clinical Testing
  - Phase II through Clinical Trial Management
  - Clinical Data Management and Biostatistical Analysis
  - Medical Writing and Regulatory Services
  - Safety/Pharmacovigilance
  - Post-Approval Services and Market Development Support
  - Informatics
  - Financial Information
- Quintiles Transnational Corporation
  - History and Lines of Business
  - Drug Development Services
  - Early Development and Services
  - Clinical Development Services
  - Financial Information
- SFBC International, Inc.
  - History and Lines of Business
  - Drug Development Services
  - Early Phase Clinical Services
  - Late Phases Clinical Services
  - General Drug Development Services
  - Financial Information
Preclinical and Clinical Laboratories
- Bioanalytical Research Corporation
  - History and Lines of Business
  - Contract Laboratory Services
  - Quality Assurance:
  - Worldwide Logistics
  - Custom Designed Supplies and Documentation
  - Project Management
  - Customized Reporting
  - Remote Data Access
  - Electronic Data Transfer
- Calvert Laboratories, Inc.
  - History and Lines of Business
  - Contract Laboratory Services
  - General Pharmacology
- CRL Medinet
  - History and Lines of Business
  - Contract Laboratory Services
  - Data Management
  - Study Management
- Huntingdon Life Sciences
  - History and Lines of Business
  - Contract Laboratory Services
- Kronos Science Laboratories, Inc.
  - Contract Laboratory Services
- Medtox Scientific Inc.
  - History and Lines of Business
  - Contract Laboratory Services
  - Financial Information
- Pacific Biometric, Inc.
  - History and Lines of Business
  - Contract Laboratory Services
- Perry Scientific, Inc.
  - History and Lines of Business
  - Laboratory Contract Services
  - Pharmacokinetic, ADME and Efficacy Studies
  - Preclinical MRI Imaging
  - Cell and Tissue Culture
  - Dermatological Studies
  - Drug and Device Efficacy Studies
  - Surgical Studies
  - Toxicology Screening
  - Studies with Human Tissue
- PRL Central Laboratory Services
  - History and Lines of Business
  - Contract Laboratory Services
  - Laboratory Data Management Solutions
  - Effective Execution for Protocol Compliance
  - Clinical Laboratory Science-A PRL Core Competency
- Synarc, Inc.
  - History and Lines of Business
  - Contract Laboratory Services
- TGA Sciences, Inc.
  - History and Lines of Business
  - Contract Laboratory Services
  - Assay Development
  - Assay Validation
  - Sample Handling and Analysis
  - In Vivo Animal Studies
  - FACS Analysis
Site Management Organizations
- Accelovance
  - History and Lines of Business
  - Clinical Trials Services
- CNS Clinical Trials
  - History and Lines of Business
  - Clinical Trials Services
  - Phase I
  - Phase II-IV
  - Other Services
- DaVita Clinical Research
  - History and Lines of Business
  - Clinical Trials Services
  - Clinical Trials I
  - Clinical Trials II-IV
  - General Clinical Trial Services
  - Features of Facilities include:
- JFJ Research Services, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - Project Management
  - Subject Recruitment
- Radiant Research
  - History and Lines of Business
  - Clinical Trials Services
  - Patient Recruitment Services
  - Call Center Services
  - Training Participant Screeners
  - Telephone Screening Process
  - Periodic Reporting
  - Media Development and Placement
  - Project Management
- Research Solutions LLC
  - History and Lines of Business
  - Clinical Trial Services
  - Centralization of Clinical Trial Start-up
  - Clinical Operations
  - Information Technology
  - Investigator Services
  - Qualified Experienced Investigators
  - Patient Recruitment and Call Center
- SMO-USA, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - Highly Experienced Principle Investigators
  - Trial Manager
  - Access to a Large Patient Study Population
  - Patient Recruiting
Niche Competitors
- Acurian, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - AcuPatient: Accelerate Patient Recruitment
  - AcuSite: Select the Right Investigator
  - AcuChart: Target Investigator’s Patient Population
- Advanced Clinical Software
  - History and Lines of Business
  - Clinical Trials Services
  - Study Manager Web Edition
  - Study Recruiter
  - StudyWeb Information and Collaboration System
- Clinical Trial Services
  - History and Lines of Business
  - Clinical Trials Services
  - Manufacturing, Primary and Secondary Packaging Services
  - Specialized Manufacturing/Packaging Services
  - Labeling Services
  - Storage, Distribution and Returns Services
  - Analytical Services
  - Specialist Clinical Management
- eResearch Technology, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - eResearch Network Technology: eResNet
  - eData Entry Technology: eDE
  - eResCom
  - eStudy Conduct
  - eData Management
  - EXPeRT"eECG
  - eSafety Net
  - Financial Information
- eTrials Worldwide, Inc.
  - History and Lines of Business
  - Clinical Trials Services
  - Electronic Data Capture
  - Electronic Patient Reported Outcomes: ePRO
  - Randomized Enrollment Module
  - Site Management
  - Supplies Management
  - Analytics
  - Reporting
  - Electronic Diaries
  - QuickStudy Voice
  - ASCompare: Electronic Data Review
  - Regulated Compliant Systems
- Interactive Clinical Technologies, Inc.
  - History and Lines of Business
  - Clinical Trials Services
  - Interactive Voice Response System (iVRS)
  - iTrial EDC
  - iDiary (ePRO)
  - Statistical Services
  - Clinical Supplies Forecasting
  - Clinical Hotline
  - EZ-link Total Clinical Supply Management
  - Data Integration
  - Adaptive Trial Design
  - Quality Services
- Fast Track Systems, Inc.
  - History and Lines of Business
  - Clinical Trials Services
  - TrialSpace Designer (TSD)
  - CROCAS PBT
  - TrialSpace Grants Manager
  - Consulting Services
- Fisher Clinical Services
  - History and Lines of Business
  - Clinical Trial Services
  - Manufacturing Services
  - Label Printing Services
  - Storage & Global Distribution Services
  - IVR Services (FACTS)
  - Return Accountability & Destruction
- Outcome Sciences, Inc.
  - History and Lines of Business
  - Clinical Trial Services
- Perceptive Informatics, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - CTMS (Clinical Trials Management Systems)
  - IVRS (Interactive Voice Response Systems)
  - Portals
  - Imaging
  - Integration
  - Financial Information
- Pharsight Corporation
  - History and Lines of Business
  - Clinical Trials Services
  - WinNonlin and WinNonMix
  - PharsightKnowledgebase Server (PKS)
  - Trial Simulator
  - Drug Model Explorer (DMX)
  - Financial Information
- Phase Forward, Inc.
  - History and Lines of Business
  - Clinical Trial Services
  - InForm
  - Clintrial
  - Clintrace
  - WebVDME
  - CTSD
  - WebSDM
  - Product Integration
  - Financial Information

List of Exhibits
chapter one: Executive Summary

Figure 1-1: The U.S. Drug Discovery, Development, and Approval Process
Figure 1-2: U.S. Clinical Trial Enrollment Delays Worsen
Figure 1-3: Projecting Phase I-IIIB/IV Projects Using EDC in 2004
Figure 1-4: A Ten-Year Historical Perspective: Growth of Outsourcing in Drug Development, 1993-2003
Table 1-1: Global Drug Development Expenditures and Outsourced Drug Development Spending 2000-2010
Figure 1-5: Contract Drug Development Market Share by Competitor Type (Academic Medical Centers, Site Maintenance Organizations, Contract Research Organizations) 2005
Table 1-2: Market Summary: Contract Drug Development Market 2001, 2005, 2010

chapter two: Introduction to Drug Development

Table 2-1: Number of IND Submissions for Drugs 1992-2004
Figure 1-1: The U.S. Drug Discovery, Development, and Approval Process
Table 2-2: Number of Clinical Trials Initiated Annually for U.S. Submissions by Type
Table 2-3: Median Total Approval Time for Standard NDAs 1993-2004
Table 2-4: Median Total Approval Time for Priority NDAs, 1993-2004
Table 2-5: Median Total Approval Time for Standard NMEs 1995-2004
Table 2-6: Median Total Approval time for Priority NMEs 1995-2004
Figure 2-2: Median Approval times for Safety vs All Drugs, By Decade
Figure 2-3: Approval Times for Priority, Standard and Fast Track Approvals, 1998-present

chapter three: Clinical Trials Operations

Table 3-1: Key Clinical Trial Enrollment Statistics for NMEs Approved in 1999-2004 (Mean Patients per NDA; Median Patients per NDA; Range)
Table 3-2: Number of Active Clinical Drug Development Programs (March 2005)
Table 3-3: Total Average Number of Active Clinical Drug Development Programs by Year, 2001-2005
Figure 3-1: NME Approvals in the U.S. with Post Approval Commitments
Table 3-4: Summary of Post-Marketing Study Commitments as of 30-Sep-05
Figure 3-2: U.S. Clinical Trial Enrollment Delays Worsen
Table 3-5: Total Spending on Mass Media Recruitment Promotion 1998-2003
Table 3-6: Benefits and Risks of Participating in Clinical Trials
Table 3-7: Clinical Trials Retention Rates, Phases I-IV
Figure 3-3: Average Number of Sites by Phase
Figure 3-4: Average Number of Patients by Phase
Table 3-8: Aggregate Enrollment Data for All Extramural Research Protocols Reported in 2003 (Number and Percentage of Total) by Race/Ethnicity and Sex
Table 3-9: Aggregate Enrollment Data for Intramural Research Protocols Conducted On-Site and Off-Site, 2003 (Number and Percentage of Total) by Race/Ethnicity and Sex

chapter four: Competing in the Contract Drug Development Industry

Table 4-1: New and Old Paradigms for Pharmaceutical R&D
Table 4-2: Improvements in the Drug Development Process Reduce Development Costs (Quantification of Time, Success, and Expense Improvements)
Figure 4-2: Trending in R&D Spending Growth Rate, 1993-2003
Figure 4-3: Trending in Outsource Spending Growth Rate, 1993-2003
Figure 4-4: A Ten-Year Historical Perspective: Growth of Outsourcing in Drug Development, 1993-2003 (Total R&D Spending vs Total Outsource Spending)
Table 4-3: Academic Medical Centers vs. Independent Sites: Percentage of Industry-Sponsored Clinical Trials 1991-2006

chapter five: Contract Drug Development Market

Table 5-1: Global Drug Development Spending 2000-2010
Table 5-2: R&D Spending in 2004 of Top Pharmaceutical Companies, Ranked by 2004 Sales
Figure 5-1: Mean Total Development Times* for Pharmaceuticals and Biologic Products Approved in the United States by Time Period 1985-1989, 1990-1994, 1995-1999, 2000-2004
Table 5-3: R&D Spending in 2004 of Top Biopharmaceutical Companies, Ranked by 2004 Sales
Table 5-4: Number of Companies with Active Product Development Projects, 1997-2004
Table 5-5: Worldwide Active R&D Projects in Development by Stage 1998-2005
Table 5-6: Number of Compounds in R&D in the United States by Top Ten Therapeutic Categories, 2004
Table 5-7: Number of Compounds in R&D Worldwide by Top Twelve Therapeutic Categories March 2005 vs March 2004.
Table 5-8: Global Drug Development Expenditures and Outsourced Drug Development Spending 2000-2010
Table 5-9: World Preclinical and Phase I Clinical Trials Market 2003-2008
Table 5-10: World Clinical Trials Phase IIIb/IV Market 2003-2008
Figure 5-2: Contract Drug Development Market Share by Competitor Type (Academic Medical Centers, Site Maintenance Organizations, Contract Research Organizations) 2005
Table 5-11: Contract Drug Development Market 2000-2010
Table 5-12: Contract Drug Development Market by Competitor Type (CROs, AMCs, SMOs, and Others) 2000-2010
Table 5-13: Revenues and Market Share of Publicly-Traded CROs 2004
Table 5-14: Selected Acquisitions by CROs 2004 to Present
Table 5-15: Annual Growth in Number of Trials Using an SMO, 2000-2004
Figure 5-3: Driving Forces Accelerating and Limiting IT Improvements over the Next 3 to 5 Years
Figure 5-4: Percent of Phase I-IV Trials using EDC, Sponsors vs. CROs 2000-2004
Figure 5-5: Electronic Data Capture Market 2000-2004