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

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

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