Rodman final-datatrak international


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DATATRAK's investor Presentation at the Rodman and Renshaw conference focused on the market opportunities driven by increasing industry demand for a best-in-class, truly-unified clinical trial solutions. The Company's DATATRAK ONE™ solution provides customers a unified approach to product and services delivery that ensures the safety, simplicity, and speed of clinical trials.

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  • It takes 10-15 years on average for an experimental drug to travel from lab to patients.Only 5 in 5000 compounds that enter preclinical testing make it to human testing.1 of the 5 tested in humans are approved by the FDA.IND = Investigational New Drug ApplicationNDA = New Drug Application
  • Larry – work in ‘interoperability is just unified integration’
  • Add build and total mkt.
  • Larry – Remember earlier in the presentation, when I told you that we can help engineer the process? Here is why it is important…Oh by the way, it’s the safest, most simplistic and fastest.While others are talking of lowering the cost of technology, we are helping our clients lower the costs of clinical trials.From Larry: “Help drug companies manage their portfolio of clinical trials from concept to cure.”
  • Rodman final-datatrak international

    1. 1. Rodman & Renshaw Annual Global Investment Conference<br />Laurence P. Birch<br />Chairman of the Board and CEO<br />DATATRAK International, Inc.September 13, 2010<br />
    2. 2. Forward Looking Statements<br />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.<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    3. 3. DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />DATATRAK International, Inc. <br />A Sound Investment. <br />Let me Tell you Exactly Why…<br />
    4. 4. DATATRAK Confidential<br />DATATRAK ONE ™ <br />Safety. Simplicity. Speed.<br /><br />
    5. 5. Corporate Overview<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    6. 6. Corporate Overview<br />DATATRAK Confidential<br /><br />Overview<br /><ul><li> Founded 1993; Operating as Internet-based cloud since 2005
    7. 7. Continuous investment in robust development
    8. 8. Managing hundreds of studies across 8300 sites with 120,000 patients in 59 countries
    9. 9. Profitable and cash flow positive
    10. 10. Increasing backlog
    11. 11. No debt
    12. 12. Not subject to third-party patents
    13. 13. DATATRAK ONE™
    14. 14. First eClinical platform on the market
    15. 15. The only true Unified system
    16. 16. Leader in clinical data management solutions
    17. 17. Founded 1993; Operating as Internet-based cloud since 2005
    18. 18. Continuous investment in robust development
    19. 19. Managing hundreds of studies across 8300 sites with 120,000 patients in 59 countries
    20. 20. DATATRAK ONE™
    21. 21. First eClinical platform on the market
    22. 22. The only true Unified system
    23. 23. Leader in clinical data management solutions
    24. 24. DATATRAK ONE™
    25. 25. First eClinical platform on the market
    26. 26. The only true Unified system
    27. 27. Leader in clinical data management solutions
    28. 28. Profitable and cash flow positive
    29. 29. Increasing backlog
    30. 30. No debt
    31. 31. Not subject to third-party patents
    32. 32. Founded 1993; Operating internet based cloud solutions since 2005
    33. 33. Continuous investment in robust development
    34. 34. Managing hundreds of studies across 8300 sites with 120,000 patients in 59 countries</li></ul>DATATRAK’s vision is to be the clinical enterprise solution to safely accelerate every drug, every biologic and every device from concept to cure.<br />DATATRAK’s vision is to be the clinical enterprise solution to safely accelerate every drug, every biologic and every device from concept to cure.<br />Solutions<br />History<br />DATATRAK’s vision is to be the clinical enterprise solution to safely accelerate every drug, every biologic and every device from concept to cure.<br />Financial Record<br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    35. 35. Team Bios<br />Laurence Birch, CEO and Chairman<br />Executive experience in multiple companies including CEO, President and CFO and maintains a CPA certification<br />MBA Kellogg School of Business at Northwestern University<br />Significant turnaround experience – Baxter Healthcare; EDS; Aksys, Ltd; NeoPharm, Inc. and DATATRAK International<br />Scaled both Healthcare and IT businesses – eg. Baxter Arthroscopy; EDS Y2K Practice<br />Chris Wilke, CTO<br />14 years industry experience<br />Co-developed business plan for eClinical market in 1995<br />Implemented early Internet-based registry, 20,000+ patients<br />Founding member of EMSw; acquired by ClickFind<br />Original product architect for eClinical<br />Bill Gluck, VP Clinical Services<br />PhD with 10 years Academia experience<br />25 years industry experience, Pharma and CRO<br />Instructor for the Clinical Data Management Certification program at Durham Technical Community College<br />Bill Coates, VP Sales<br />30+ years business experience, 10+ years industry experience<br />Experience with eleven acquisitions, four as lead executive<br />Executive member of management team responsible for growing AMS from 45 to over 700 employees (sold for $345 million to Fiserv)<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />Over 100 years collective executive experience<br />
    36. 36. Market Overview<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    37. 37. Market Overview – Recovery in Progress<br />Global Pharma market expected to experience 5-8% compounded annual growth through 2014.<br />Grow by $300 million to over $1.1 trillion in 2014<br />Pharmerging markets growing at a rate of 14-17% through 2014<br />2010 Q2 VC spending on Biotechs increased 59% ($1.3 billion) as compared to 2010 Q1<br />European Commission announced €6.4 billion package aimed at research and innovation<br />Health €682 billion and SMEs €800 billion<br />Generics market is booming<br />76% of US prescriptions are generics<br />2011 $32 billion and 2012 $24 billion in patents will expire<br />Post-consolidation stability<br />Pfizer – Wyeth 2010 Q2 sales increased 49% to $15.02 billion<br />Watson Pharmaceuticals net revenue grew 29% for 2010 Q2 to $875.3 million<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    38. 38. Market Overview – Risks Still Evident<br />Increasing research and development costs<br />2008 fewest number of drugs approved by FDA (a 20 year low), citing more data needed with regulatory submissions<br />Overhaul of 510(k) fast-track device approval process<br />Drug quality and safety<br />2009 record 1742 drug recalls in US – 400% increase from 2008<br />Johnson & Johnson recall for inadequate quality controls in manufacturing of products<br />Bristol-Myers Squibb Recalls Coumadin (R) 1 mg Tablet Blister due to decrease of active ingredient<br />Reports of unsafe ingredients in dietary supplements<br />Consolidation in BioPharm industry<br />Reduces drug development pipelines<br />Reduces number of solution providers needed to support clinical trials<br />CRO market growth projected but CROs struggling<br />ICON reported operating income for Q2 down by 12.3% <br />Covance Q2 profit declined 26% from last year<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    39. 39. Drug Development Process<br />DATATRAK Confidential<br /><br />File IND at FDA<br />File NDA at FDA<br />The Drug Development and Approval Process by PhRMA<br />According to The Price of Innovation: New Estimates of Drug Development Costs, the average cost of successfully developing a new molecular entity, including R&D expenditures on failed drug projects, was $802M in 2000.<br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    40. 40. Clinical Trial Components<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    41. 41. The Challenge<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    42. 42. Plan<br />Study Setup<br />Study<br />Activities<br />Analyze & Report<br />Submission<br />
    43. 43. Technology Approaches<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    44. 44. Two High Level Approaches<br />1. Information Silos & IT Integration<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />Safety…<br />Coding<br />CTMS<br />IVR<br />EDC<br />
    45. 45. Information Silos & IT Integration Approach <br /><ul><li>Integration to create a solution may provide short term gratification – upgrades are difficult and rare.
    46. 46. Integration often leads to management of multiple vendor contracts.
    47. 47. Integration typically leads to manual management of data, systems and user accounts.
    48. 48. Validation of multiple vendors and systems will be required.</li></ul>Difficult to do<br />Process Reengineering<br />System Mappings<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    49. 49. Two High Level Approaches<br />1. Information Silos & IT Integration<br />2. Unified Platform & Organization<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />Safety…<br />Coding<br />CTMS<br />IVR<br />EDC<br /><ul><li> One Database
    50. 50. One Process
    51. 51. One Platform
    52. 52. One Unified Suite
    53. 53. One Common Interface
    54. 54. Import / Export Tools</li></li></ul><li>Unified Platform, Process & Organization Approach<br /><ul><li>Unified solutions provide improved usability via one database and one interface.
    55. 55. Unified solutions reduce the number of vendor contracts.
    56. 56. Unified solutions can enable process improvements.
    57. 57. Unified solutions only require validation of a single vendor. </li></ul>Process Reengineering Easier<br />System Mappings<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    58. 58. Why Unified is Better<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    59. 59. DATATRAK’s Unified Solution<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    60. 60. The UnifiedSolution<br />DATATRAK Consulting Services<br />C<br />T<br />M<br />S<br />Submission<br />Safety<br />Enterprise<br />Manager<br />Trial Manager<br />C<br />T<br />M<br />S<br />Submission<br />Safety<br />Enterprise<br />Manager<br />Trial Manager<br />C<br />T<br />M<br />S<br />Submission<br />Safety<br />Enterprise<br />Manager<br />Trial Manager<br />IRT<br />IRT<br />IRT<br />EDC<br />CDM<br />EDC<br />CDM<br />EDC<br />CDM<br />ECGs & Images<br />ECGs & Images<br />ECGs & Images<br />Inventory<br />Management<br />Inventory<br />Management<br />Inventory<br />Management<br />Randomization<br />Randomization<br />Randomization<br />Coding<br />Coding<br />Coding<br />Import / Export<br />Import / Export<br />Import / Export<br />DATATRAK eClinical™ Platform<br />DATATRAK eClinical™ Platform<br />DATATRAK Integrator™<br />DATATRAK Integrator™<br />Other<br />Modules<br />Other<br />Modules<br />LABS<br />Data<br />Warehouse<br />LABS<br />Data<br />Warehouse<br />SAS<br />SAS<br />
    61. 61. Benefits of DATATRAK ONE™<br />Safety:<br /><ul><li>Enhanced Visibility
    62. 62. Real-Time Reporting & Exporting
    63. 63. Process Efficiency</li></ul>Simplicity:<br /><ul><li>Develop Cross-Study Standards through “eClinical Library”
    64. 64. Predictable Cost Structure
    65. 65. Unified User Experience</li></ul>Speed:<br /><ul><li>Faster Trial Start-up
    66. 66. Faster Trial Close
    67. 67. Data Availability in Real-Time</li></ul>DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    68. 68. Growth Strategy<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    69. 69. Growth Expectations<br />DATATRAK Confidential<br /><br />2012 = $1,865M<br />2008 = $937M<br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    70. 70. Competitive Environment<br />Acquisition of Phase Forward by Oracle highlights:<br />Legitimizesstrategic importance of industry<br />Confirms growth potential of clinical trial space<br />Validates the market demand for end-to-end solutions like DATATRAK ONE™<br />Market favoring Companies with end-to-end eClinical solutions<br />DATATRAK has provided this technology longer than any other market participant<br />DATATRAK is the only unified solution available in the market<br />Others are spending heavily in R&D to go where we already are<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    71. 71. Rationalized Business Model<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    72. 72. Investment in the Future<br />Focus on Marketing Efforts<br /><ul><li>Participated in the 13th Annual DIA Workshop in Japan with Japanese partner, NTT DATA
    73. 73. Co-sponsored seminar in Israel focusing on eClinical Solutions for the clinical trials industry
    74. 74. Exhibited at the DIA’s 22nd Annual EuroMeeting at the Grimaldi Forum in Monaco
    75. 75. Exhibited at the 2010 ASCO Annual Meeting, including introduction of DATATRAK’s oncology offering
    76. 76. Exhibited at the DIA 26th Annual Meeting, including the premier of the DATATRAK Safety Case ManagerTM
    77. 77. Presented at the 2010 OneMedForum in San Francisco and New York
    78. 78. Recognized as 2010 Crain’s Leading Edge Award Winner</li></ul>Continued Improvement of DATATRAK eClinical™ Platform<br /><ul><li>Restructured pricing and contracting practices to provide ‘flexibility’ across study phases
    79. 79. Enhanced import/export tools including CDISC SDTM, and Safety tools
    80. 80. Enhanced data entry and cleaning tools
    81. 81. Improved learning and knowledge delivery tools
    82. 82. Added Advanced character management for Japanese market
    83. 83. Provided seamless experience on the Apple® iPad™
    84. 84. Development of DATATRAK Safety Case Manager™
    85. 85. Incorporated more than 200 new customer requested features
    86. 86. Major software release scheduled for October 2010</li></ul>DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    87. 87. Numerous Growth Opportunities<br />Increase Current eClinical Customer Penetration<br />Expand eClinical Customer Base<br />Accelerate Sales through CRO Channel<br />Expand Consulting Services Offering<br />Introduce New and Differentiated Products<br />Develop Pharmerging Market Strategy<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    88. 88. Summary<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />
    89. 89. DATATRAK International, Inc.A Sound Investment. And Let me Tell you Exactly Why…<br />Growing clinical trial complexity continues to challenge the ability of pharmaceutical and biotechnology companies to contain the ever-rising cost of developing new drugs.<br />Tufts Center for the Study of Drug Development – May 5, 2010<br />DATATRAK Confidential<br /><br />DATATRAK ONE ™<br />Safety. Simplicity. Speed.<br />Two vendor approaches to the increasing costs and complexity:<br />DATATRAK reduces the complexity and cost of clinical trials.<br />DATATRAK ONE™:<br /><ul><li>Lowers Data Management Costs
    90. 90. Facilitates Process Re-engineering
    91. 91. Accelerates Trial Timelines
    92. 92. Improves Patient Safety</li></ul>Resulting in…<br /><ul><li>Increased Return on Investment for our customers
    93. 93. Paradigm-shift that has our competitors scrambling to duplicate</li></ul>From Concept to Cure, DATATRAK drives shareholder value.<br />Integration<br />(Lowers technology costs)<br />Unified<br />(Lowers trial costs)<br />complexity<br />cost<br />
    94. 94. 12-month Share Price Trend<br />DATATRAK ONE<br />Q3 RESULTS<br />NEW EURO CLIENTS<br />Q4 RESULTS<br />TREASURY SHARES<br />DAIICHI<br />WILKE CTO<br />STDS EXPAND<br />JAPAN DIA<br />Q1 RESULTS<br />
    95. 95. DATATRAK ONE™ Difference:<br />DATATRAK Worldwide<br />Mayfield Heights, Ohio<br />440-443-0082<br />Bryan, Texas<br />979.393.9020<br />Europe<br />+49-2226-169-540<br /><br />Increasing Patient Safety<br />Increasing Process Efficiency in Clinical and Safety<br />Data Availability in real time<br />Cost Reduction in maintenance, validation, administration and training<br />Unified User Experience the eClinical platform, anywhere in the world<br />LOWER TRIAL COSTS<br />DATATRAK ONE™<br />Safety. Simplicity. Speed<br />DATATRAK Confidential<br /><br />