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DATATRAK International, Inc. (DATA.PK)

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DATATRAK delivers end-to-end clinical trial solutions, powerful data management features and a seamless operational experience - all through the delivery method, DATATRAK ONE. Learn more at: …

DATATRAK delivers end-to-end clinical trial solutions, powerful data management features and a seamless operational experience - all through the delivery method, DATATRAK ONE. Learn more at: http://www.onemedplace.com/database/list/cid/197


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    • 1. DATATRAK International, Inc.June 30, 2010
      OneMedForum-New York
      Laurence P. Birch
      Chairman of the Board and CEO
    • 2. Forward Looking Statements
      This presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including the limited operating history on which the Company’s performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs, and other factors. Accordingly, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update or revise any forward-looking information contained in this presentation.
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 3. Corporate Overview
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 4. About our leadership…
      Laurence Birch, CEO and Chairman
      Executive experience in multiple companies including CEO, President and CFO and maintains a CPA certification
      MBA Kellogg School of Business at Northwestern University
      Significant turnaround experience – Baxter Healthcare; EDS; Aksys, Ltd; NeoPharm, Inc. and DATATRAK International
      Scaled both Healthcare and IT businesses – eg. Baxter Arthroscopy; EDS Y2K Practice
      Chris Wilke, CTO
      14 years industry experience
      Co-developed business plan for eClinical market in 1995
      Implemented early Internet-based registry, 20,000+ patients
      Founding member of EMSw; acquired by ClickFind
      Original product architect for eClinical
      Bill Coates, VP Sales
      30+ years business experience, 10+ years industry experience
      Experience with eleven acquisitions, four as lead executive
      Executive member of management team responsible for growing AMS from 45 to over 700 employees (sold for $345 million to Fiserv)
      Jennifer Fox, CFO
      CPA, M.S. Accounting
      15+ years business experience; 10+ years industry experience
      Big 4 public accounting experience – KPMG
      Founding principal & CFO of ClickFind – eClinical development team
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 5. DATATRAK International, Inc., A Sound Investment. And Let me Tell you Exactly Why…
      DATATRAK is ready for regulatory challenges
      DATATRAK has strong financial fundamentals
      Superior product
      Lowers technology AND trial costs
      Superior customer service
      Dedication and investment in our technology
      Investment is customer and regulatory driven
      Growing clinical trial complexity continues to challenge the ability of pharmaceutical
      and biotechnology companies to contain the ever-rising cost of developing new drugs.
      Tufts Center for the Study of Drug Development – May 5, 2010
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 6. eClinical Market
      EDC Market Size [EDC and CDM] [William Blair, 03/18/2009]
      2007 market opportunity was roughly $330 million
      Expect it to increase to roughly $745 million in 2012
      Growth rate is 15% per year through 2012
      IRT Market Size [Randomization and Inventory Management]
      Market valued at $250 million in 2008 [William Blair, 03/18/2009]
      Growth around 15% a year [Outsourcing-Pharma.com, 09/09/2008]
      Safety Market Size [Coding and PMS] [William Blair, 03/18/2009]
      Market opportunity is approximately $20 million as of 2008
      Expected to grow to roughly $70 million by 2012
      CTMS Market Size [CTMS] [Frost and Sullivan; Outsourcing-Pharma.com, 7/15/2008 ]
      Generated revenues of $237.6 million in 2007
      Expected to grow at a rate of 14.5% per year until 2014
      Core Lab Market Size [ECGs and Images]
      Market valued at $100 million in 2008 [COResearch, 2008]
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 7. Growth Expectations
      DATATRAK Confidential
      DATATRAK ONE™
      Safety – Simplicity – Speed
      www.datatrak.net
      2012 = $1,865M
      2008 = $937M
    • 8. The Challenge
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 9. Two High Level Approaches
      1. Information Silos & IT Integration
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
      Safety…
      Coding
      CTMS
      IVR
      EDC
    • 10. Information Silos & IT Integration Approach:
      • Integration to create a solution may provide short term gratification – upgrades are difficult and rare.
      • 11. Integration often leads to management of multiple vendor contracts.
      • 12. Integration typically leads to manual management of data, systems and user accounts.
      • 13. Validation of multiple vendors and systems will be required.
      Difficult to do
      Process Reengineering
      Contracts
      System Mappings
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 14. Two High Level Approaches
      1. Information Silos & IT Integration
      2. Unified Platform & Organization
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
      Safety…
      Coding
      CTMS
      IVR
      EDC
      DATATRAK ONE™
    • Unified Platform, Process & Organization Approach
      • Unified solutions provide improved usability via one database and one interface.
      • 20. Unified solutions reduce the number of vendor contracts.
      • 21. Unified solutions can enable process improvements.
      • 22. Validation of single vendor is typically required.
      Process Reengineering Easier
      System Mappings
      Contract
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 23. Why Unified is Better
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 24. DATATRAK ONE™
      Exceed Interoperability Needs
      Implement Products in any Combination
      Interoperate with Other Vendors of Choice
      Leverage Standards
      Construct a Scalable Platform
      Provide Superior Performance
      Deliver Solutions Online
      Provide Best-of-breed Functionality
      Create Trial Initiation-to-Submission Efficiencies
      Ensure Ease of Use
      Provide Configurable Role-Based Permissions
      Create Single Vendor Efficiencies
      Reduce the Number of Contracts
      Simplify Design and Validation Efforts
      Maintain Flexibility
      • One Database
      • 25. One User Interface
      • 26. One eClinical Suite
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 27. Benefits of DATATRAK ONE™
      Safety:
      • Enhanced Visibility
      • 28. Real-Time Reporting & Exporting
      • 29. Process Efficiency
      Simplicity:
      • Develop Cross-Study Standards through “eClinical Library”
      • 30. Predictable Cost Structure
      • 31. Unified User Experience
      Speed:
      • Faster Trial Start-up
      • 32. Faster Trial Close
      • 33. Data Availability in Real-Time
      Return on Investment
      • Lower technology costs
      • 34. Lower overall trial budgets
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 35. First Quarter Results2010 vs. 2009Unaudited
      DATATRAK Confidential
      DATATRAK ONE™
      Safety – Simplicity – Speed
      www.datatrak.net
      Q1 New Sales
      $2,375,000
      225% Increase
      Industry Leading Margins
      Profitability
      3rd Qtr-Over-Qtr Increase
    • 36. 2010 Updates
      Q1 2010 Profitability
      • First time for DATATRAK to show profit in almost 5 years
      • 37. No debt, with exception of trade payables
      • 38. Gross Profit Margin = 82% (2010 Q1)
      Improved Backlog
      • Q4 2009 backlog increased 7% over Q3 (2nd consecutive quarter-over-quarter increase)
      • 39. Q1 2010 backlog of $10.673 million (3rd consecutive quarter-over-quarter increase)
      • 40. Current Backlog covers 73% of 2010 projected Expenses
      Strengthened Sales Pipeline
      • Q1 2010 New Sales of $2.375 million – 225% increase over 2009
      Rationalized Business Model
      • Ability to deliver services is enhanced and strengthened
      • 41. Costs aligned with revenue stream
      • 42. No debt
      Removal of Going Concern Qualification by Independent Auditors
      • 12/31/2009 Financial Statements do not include a Going Concern Qualification
      Continued Improvement of DATATRAK ONE eclinical Platform
      • Restructured pricing and contracting practices to provide ‘flexibility’ in our models
      • 43. Enhanced import/export tools including CDISC SDTM, and Safety tools
      • 44. Enhanced data entry and cleaning tools
      • 45. Improved learning and knowledge delivery tools
      • 46. Added Advanced character management for Japanese market
      DATATRAK Confidential
      DATATRAK ONE™
      Safety – Simplicity – Speed
      www.datatrak.net
    • 47. Competitive Environment
      Acquisition of Phase Forward by Oracle highlights:
      Emphasizes strategic importance of industry
      Confirms growth potential of clinical trial space
      Legitimizes the market demand for end-to-end solutions like DATATRAK ONE™
      Market favoring Companies with end-to-end eClinical solutions
      DATATRAK has provided this technology longer than any other market participant
      Others are spending heavily in R&D to go where we already are
      DATATRAK is the only unified solution available in the market
      As a pioneer of the space, DATATRAK is well positioned for continued growth due to our innovative approach to solving the market’s complexity, financial stability and comprehensive, mature platform.
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 48. Numerous Growth Opportunities
      DATATRAK ONE is the best solution for upcoming changes in the clinical trials industry due to regulatory changes
      DATATRAK ONE is the most developed eclinical platform available
      Increased current eClinical customer relationships
      Expanding eClinical Customer Base
      Accelerate sales through CRO Channel
      Cross-sell DATATRAK ONE products and services
      DATATRAK Confidential
      www.datatrak.net
      DATATRAK ONE ™
      Safety. Simplicity. Speed.
    • 49. DATATRAK ONE™ Difference:
      DATATRAK Worldwide
      Mayfield Heights, Ohio
      440-443-0082
      Bryan, Texas
      979.393.9020
      Europe
      Bonn, Germany
      +49-2226-169-540
      www.datatrak.net
      Increasing Patient Safety
      Increasing Process Efficiency in Clinical and Safety
      Data Availability in real time
      Cost Reduction in maintenance, validation, administration and training
      Unified User Experience the eClinical platform, anywhere in the world
      LOWER TRIAL COSTS
      DATATRAK ONE™
      Safety. Simplicity. Speed
      DATATRAK Confidential
      www.datatrak.net