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Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
Accelerating Clinical Trials
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Accelerating Clinical Trials

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  • 1. Accelerating Clinical Trials Laurence P. Birch, CEO
  • 2. Forward Looking StatementsThis presentation contains "forward-looking statements" withinthe meaning of the “safe-harbor” provisions of the PrivateSecurities Litigation Reform Act of 1995. Such statements involveknown and unknown risks, uncertainties and other factors thatcould cause the actual results of the Company to differmaterially from the results expressed or implied by suchstatements, including the limited operating history on which theCompany’s performance can be evaluated; the ability of theCompany to continue to enhance its software products to meetcustomer and market needs, and other factors. Accordingly,there can be no assurance that such expectations will prove tobe correct. The Company has no obligation to update or reviseany forward-looking information contained in this presentation.DATATRAK from Concept to Cure™ www.datatrak.net
  • 3. Mission Statement DATATRAK’s mission is to be the clinical enterprise solution to safely accelerate every drug, every biologic and every device from Concept to Cure™DATATRAK from Concept to Cure™ www.datatrak.net
  • 4. Why is a unified solution important? Life science organizations are always looking for solutions to help move their research forward swiftly and safely.DATATRAK from Concept to Cure™ www.datatrak.net
  • 5. Market Overview # of R&D Projects in Clinical Trials 5,000 $131.7B Global R&D 4,800 4,791 Spend 4,600 4,523 4,400 $53B Clinical 4,173 4,200 4,080 Development Spend 4,000 $2B Clinical 3,800 Technology Spend 3,600 2008 2009 2010 2011 # of R&D Projects in Development 4,100 organizations 5,400 5,254 5,200 5,000 4,915 4,820 Drug Development Process 4,800 4,600 4,524Cost = $1.2B Time = 10-15 yrs 20-year patent 4,400 4,200 Concept Cure 4,000 2008 2009 2010 2011 DATATRAK from Concept to Cure™ www.datatrak.net
  • 6. Market Challenges Create Opportunities• Increasing number of drug failures ҉ Number of NDA submissions trending down over last three years √ US approvals of new drugs hit a seven-year high last year (30)• Stagnant product lines ҉ M&A, big pharma and healthcare reform √ More investment in non-blockbuster drugs and small Biotechs• Patent expirations for blockbuster drugs ҉ Development of cheaper generic drugs √ Increased number of clinical trials for generics The need to speed successful drugs and• Heightened regulatory oversight ҉ Tighter controls in approval processes devices to the √ eSource draft guidance favors unified systems market safely is more critical than ever.• Global challenges ҉ Growth of emerging markets √ NTT and other global initiativesDATATRAK from Concept to Cure™ www.datatrak.net
  • 7. How does technology affect Clinical Trial Development timelines?DATATRAK from Concept to Cure™ www.datatrak.net
  • 8. eClinical Landscape Problems• Built on Decades of Independently Evolving Systems• Laden with Silos• Redundant Processes• Inhibits Decision Making• Lost Time It’s complex!DATATRAK from Concept to Cure™ www.datatrak.net
  • 9. eClinical Landscape Problems• Built on Decades of Independently Evolving Systems• Laden with Silos• Redundant Processes• Inhibits Decision Making• Lost Time It’s complex!DATATRAK from Concept to Cure™ www.datatrak.net
  • 10. Document Management Plan User Management Trial Setup User Training Trial Design Setup Trial Deployments CTMS EDC / CDM Conduct Randomization Inventory ManagementFile Storage Coding The Integrated Solution Close Out Document Management ECGs & Images Safety Reporting CDISC Standards / Data Mapping Tools Submission Analyze & Report Archival Import / Export Submission File Storage
  • 11. The Unified Solution Plan Setup Conduct Close Out Analyze & Report Submission USubmission UAnalytics UDesign USafety UCTMS UTrain UTMF UEDC UIRT uCDR DATATRAKDATATRAKunified Software Suite ONE™ Exchange™ CDISC and Other SAS LABS Other File StorageStandards Modules
  • 12. Clinical Research with a Single Source of Truth Executive Management Biostats Clin-Ops Clinical Data Mgmt Finance Regulatory Sites Labs Unified (Single) Database CROsUnified Database is pure integration – Single point of access for all data in real-timeDATATRAK from Concept to Cure™ www.datatrak.net
  • 13. FDA eSource DRAFT Guidance DATATRAK from Concept to Cure™ www.datatrak.net
  • 14. DATATRAK ONE™ Unified Software Suite Unified Clinical Data Repository: • One Database • One Process • One Platform • One Unified Suite • One Common Interface • Import / Export ToolsDATATRAK from Concept to Cure™ www.datatrak.net
  • 15. Benefits of a Unified System• Make informed decisions faster – Track overall progress of studies and pipeline in real-time• Create new efficiencies – Eliminate manual interactions between systems – Streamline processes – Consolidate data to a single source of truth• Provides a low total cost of ownership – Easy to maintain: secure, accessible, global and sustainable – Easy to useDATATRAK from Concept to Cure™ www.datatrak.net
  • 16. Safely Accelerating Regulatory Approvals Eliminate the 8 - 12% of clinical trial costs associated with moving data around Lower technology costs by 10% - 20% Reduce study cycle times by six months or more Focus resources on more promising products Speed best candidates to market safely When you have a $1 Billion drug and you close a trial six months early, you pull forward $500 Million in new product revenue.DATATRAK from Concept to Cure™ www.datatrak.net
  • 17. Safely accelerating drugdevelopment timelines from Concept to Cure™ with DATATRAK ONE™ DATATRAK International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free www.datatrak.net

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