In Pursuit of the Paperless Clinical Trial: A look at EDC and CTMS (Strategy Focus)

Content

• Overview
• Catalyst
• Summary
• Key Messages
  • Industry pressures to cut costs have companies turning to technology solutions
  • Regulatory requirements and standards pave the road for eClinical technologies
  • eClinical solutions enable adaptive trials
  • Having seen no significant efficiencies from early clinical systems, companies are skeptical
  • In a segmented eClinical market, partnerships are essential
  • Interoperability is the key to the future
• LIST OF TABLES
  • Market Opportunity
  • Industry pressures to cut costs have companies turning to technology solutions
  • What are eClinical solutions and why should pharma care?
  • EDC systems are required to increase efficiencies within paper-based clinical trials
  • Electronic data capture provides higher quality data
  • Reduction in database lockdown time is a true measurement of EDC success
  • EDC offers many advantages over the traditional data capture process
  • The growing complexity of clinical trials calls for a robust CTMS
  • The benefits of CTMS are endless
  • Globalization adds fuel to the fire
  • Regulatory requirements and standards pave the road for eClinical technologies
  • CDISC ODM defines standards for interchange of clinical trials data
  • New CDISC initiatives support clinical systems interoperability
  • Having seen no significant efficiencies from early clinical systems, companies are skeptical
  • EDC and CTMS adoption have been hindered by pharma's aversion to change
  • Misconceptions about eClinical technologies slows down implementation
  • Until recently, there has been a lack of need for full-featured, commercial CTMS solutions
  • Customer Impact: Clinical solutions increase efficiency and reduce cost
  • eClinical solutions enable adaptive trials
  • Adaptive trials result in lower development costs, reduced time-to-market and better patient safety
  • EDC provides real-time access to patient data
  • The continuous change involved with adaptive trials requires a robust CTMS
  • A paradigm shift must take place before eClinical adoption takes-off
  • Clinical trials solutions must provide an intuitive interface
  • Life science companies must be educated about the process change involved
  • Companies will require various hosting models to meet their needs
  • Current trends in clinical trials will lead to the increase in adoption of eClinical solutions
  • Cost reduction is a major factor in adopting eClinical solutions
  • The globalization of clinical trials leads to the need for enhanced management tools
• Competitive Landscape
  • EDC solutions will no longer be a thing of the future
  • EDC solutions will soon be a commodity rather than a niche technology
  • As researchers become familiar with EDC, technology transfer models will become more commonplace
  • Standards and CRF libraries will ease the study building process
  • CTMS: a stand-alone solution or a value-added function of EDC systems?
  • CTMS solutions will be viewed as a combination of ERP and CRM technologies
• Vendor Market
  • EDC
  • Akaza Research
  • Medidata
  • Nextrials
  • OmniComm
  • Phase Forward
  • CTMS
  • Atlantic Research Group
  • Perceptive Informatics / PAREXEL International
  • Winchester Business Systems
  • eClinical Suite - EDC and CTMS
  • ClinPhone
  • Oracle
  • The future of eClinical solutions is interoperability
  • Signal detection and safety systems will become an essential aspect of an eClinical solution
  • How will electronic health records integrate with eClinical solutions?
• Go to market
  • Vendors must show how eClinical solutions will streamline the clinical process
  • Provide solutions to make Phase I EDC trials cost-effective
  • In a segmented eClinical market, partnerships are essential
  • Look to integrate essential technologies to reduce redundancy and increase efficiencies
  • Interoperability is the key to the future
  • EDC vendors must provide sufficient training for technology transfer
  • The evolution of clinical data standards will require companies to stay updated
  • Ensure that IT solutions meet government standards for electronic records
  • As clinical trials move to global locations, so should vendors
  • Definitions and Abbreviations
  • Methodology
  • Further reading
  • Ask the analyst
  • Datamonitor consulting
• Disclaimer
• LIST OF FIGURES
  • Figure 1: Challenges facing the pharmaceutical industry
  • Figure 2: Drug discovery and development process
  • Figure 3: Comparison of paper-based and EDC-based clinical trial process
  • Figure 4: Advantages of EDC over the traditional, paper-based clinical research process
  • Figure 5: Obstacles in adoption of eClinical solutions
  • Figure 6: Percent of R&D IT budget allocated to eClinical solutions in 2007
  • Figure 7: Adoption level of EDC in 2007
  • Figure 8: Summary of criteria to consider when choosing an EDC system
  • Figure 9: Most important criteria for choosing an EDC vendor
  • Figure 10: Summary of strengths and weaknesses of leading EDC vendors
  • Figure 11: Summary of key features that a CTMS should incorporate
  • Figure 12: Summary of strengths and weaknesses of leading CTMS vendors
  • Figure 13: Summary of strengths and weaknesses of leading eClinical suite vendors