The Expanding eClinical Universe:
Streamlining Progress by Changing Current
Work Processes and Moving away from Paper
Alan...
IDC Health Insights

      An IDC Company
      Premier global research and advisory firm in the health industry
      pro...
The Transformation of Clinical Trials
      Clinical trials remain the key proof needed
      to validate the performance ...
US Life Sciences Technology Adoption Map

  There are a wide variety of technology contributors in the life sciences
    i...
The Changing Clinical Development IT
  Ecosystem
      y
The eClinical IT ecosystem is becoming increasingly
 interconnect...
The IDC Health Insights View of the
    eClinical Ecosystem
                  y


      Trial
     Sponso                 ...
Clinical Trial eLandscape Vendor Offerings
                                                                 Clinical Trial...
The Electronic Data Capture (EDC)
    Market Is Maturing

                           Anticipated 2009 Adoption of EDC by P...
The eClinical Buyer’s Guide: EDC
  - Differentiation of Vendor by Market Size
                             TA B LE 3
     ...
The Shape of Things to Come

  In the not too distant future, we can
   expect to realize a number of changes to
   curren...
Questions

  Alan S. Louie, Ph.D.
  Research Di t IDC Health I i ht
  R       h Director,  H lth Insights

  Please feel f...
Terms of Use Policy

   The information enclosed is the intellectual property of Health Industry
   Insights, an IDC compa...
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The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper Alan S. Louie, Ph.D., Research Director, IDC Health Insights

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3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

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The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving Away from Paper Alan S. Louie, Ph.D., Research Director, IDC Health Insights

  1. 1. The Expanding eClinical Universe: Streamlining Progress by Changing Current Work Processes and Moving away from Paper Alan S. Louie, Ph.D., Research Director IDC Health Insights Challenges in Global Clinical Trials Conference January 28, 2010
  2. 2. IDC Health Insights An IDC Company Premier global research and advisory firm in the health industry providing integrated coverage of the life sciences, healthcare providers, and health plan payers. Focus on the convergence of IT, business and science Staff of life science and healthcare specialized analysts, researchers & consultants Target audience includes: Technology Best Practices & Directions & Benchmarking – Pharmaceutical & Biotech companies Trends – Healthcare P id H lth Providers Outsourcing Market – Payers Strategies Assessment – Health Industry Vendors Business – Technology Vendors Planning & Pl i Strategy © IDC Health Insights 2009 Page 2
  3. 3. The Transformation of Clinical Trials Clinical trials remain the key proof needed to validate the performance of a promising new drug. This critical, multi-phase, time drug critical multi phase consuming, expensive effort is receiving close scrutiny as companies drive progress forward forward. Moving from paper to electronic Shifting trials from local to global Growing trial size, driven by drug safety concerns Increasing trial costs Addressing the need to improve clinical trial efficiency Exploiting IT technological innovation © IDC Health Insights 2009 Page 3
  4. 4. US Life Sciences Technology Adoption Map There are a wide variety of technology contributors in the life sciences industry. While advances in adoption of many technologies continue to advance today, larger technology-independent issues hold the highest attention of industry decision makers. Introduction Innovation RFID Excellence Efficiency Molecular Drug Imaging CDMS Pedigrees g eClinical CTMS PAT In vitro Diagnostics BI/Analytics Biomarkers Tools EDC Predictive Whole Genome Adaptive Modeling M d li Screening S i SFA LIMS CT Designs Patient Enrollment ELN HEOR Time © IDC Health Insights 2009 Page 4
  5. 5. The Changing Clinical Development IT Ecosystem y The eClinical IT ecosystem is becoming increasingly interconnected, gaining timely access to better data, improved g g y p analytics capabilities, improved operational effectiveness, and more effective responsiveness to potential drug safety issues. Several major trends are leading the change in j g g clinical development, including: Industry-wide adoption of Electronic Data Capture Progress in clinical standards development The move towards comprehensive vendor- based eClinical solution suites Hosted and Software-as-a-Service (SaaS) as new options and a growing trend in clinical trials information management © IDC Health Insights 2009 Page 5
  6. 6. The IDC Health Insights View of the eClinical Ecosystem y Trial Sponso Trial Admin. r Mgmt TM Patient CTMS PI Recruitment Clinical Trial Design EDC FDA CDR CDMS Submission CRAs CRO ePRO Drug Safety Patient CRO Mgmt s IXR Source: IDC Health Insights, 2009 © IDC Health Insights 2009 Page 6
  7. 7. Clinical Trial eLandscape Vendor Offerings Clinical Trial EDC Drug Safety Design •Phase Forward InForm ITM •Oracle AERS/Relsys Argus • Medidata Designer •Medidata Rave Capture M did t R C t •Aris Global ARISg A i Gl b l ARIS • Phase Forward Central •Oracle RDC •Phase Forward Empirica Designer •SAS Patient Safety Thesaurus Patient CDMS Recruitment Management •Oracle Clinical •DataTrak Medical Coding •DecisionView StudyOptimizer •Medidata Rave Manager •Oracle TMS •TCN eSystems PRMS •Phase Forward Clintrial Clinical Analytics CTMS IVRS •Oracle Clinical Dev. Analytics •Siebel Clinical •Almac IXRS •SAS Drug Development •Medidata Grants Manager Medidata •Phase Forward Clarix Ph F d Cl i FDA CDR ePRO Submissions •Oracle Life Science Data Hub •PHT ePRO PHT •Phase Forward WebSDM •SAS Clinical Data Integration •Invivodata ePRO •Octagon Viewpoint © IDC Health Insights 2009 Page 7
  8. 8. The Electronic Data Capture (EDC) Market Is Maturing Anticipated 2009 Adoption of EDC by Phase 100% 80% 60% 40% 20% 0% Phase I Phase II Phase III Phase IV Based on HII projections, the number of new clinical trials using EDC exceeded 50% for the first time in 2008. EDC is continuing to expand beyond large Phase III trials. Source: IDC Health Insights, 2009 © IDC Health Insights 2009 Page 8
  9. 9. The eClinical Buyer’s Guide: EDC - Differentiation of Vendor by Market Size TA B LE 3 S e l e c t e d E D C V e n d o r s C l a s si f i c a t i o n B a s e d o n R e p o r t e d / P u b l i s h e d Rev en ue Annual Revenue EDC Vendors Major (> $100 million) Phase Forward Medidata BioClinica (Phoenix Data Systems) Mid-tier ($10-$50 million) DataTrial DSG eTrials Octagon Research Oracle Target Health Almac Small (< S ll ( $10 million) illi ) Cisiv Ci i Clinical DataFax Systems Clinsight DataTrak Logos Technologies MedNet Nextrials OmniComm PharmaVigilant StudyManager XClinical Source: Health Industry Insights, Hoov ers 2009 © IDC Health Insights 2009 Page 9
  10. 10. The Shape of Things to Come In the not too distant future, we can expect to realize a number of changes to current eClinical processes, including: – Comprehensive eClinical solutions p – Significant outsourcing and offshoring of non-core development activities – Elimination of the last bastion of paper – p p paper Master Records – A shift in processes from forms to content – Comprehensive electronic regulatory p g y filings © IDC Health Insights 2009 Page 10
  11. 11. Questions Alan S. Louie, Ph.D. Research Di t IDC Health I i ht R h Director, H lth Insights Please feel free to contact me at Phone: 508-935-4280 Email: alouie@idc.com © IDC Health Insights 2009 Page 11
  12. 12. Terms of Use Policy The information enclosed is the intellectual property of Health Industry Insights, an IDC company. Copyright 2010 - Reproduction is forbidden unless authorized. All rights reserved. Please refer to Health Industry Insights’ Terms of Use policy at http://www.idc.com/HII/PR/PRtermsofuse.jsp http://www idc com/HII/PR/PRtermsofuse jsp for more information about our terms and conditions. If you have any questions regarding permissions and restrictions regarding our brand and content, please contact Sandra Collins at 508-988-6746. © IDC Health Insights 2009 Page 12
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