Clinical Trial Management Systems 101


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Clinical Trial Management Systems 101

  1. 1. Clinical TrialManagement Systems:101Param Singh
  2. 2. Welcome & IntroductionsParam SinghVice President ofClinical Trial Management Solutions• 10+ years of experienceimplementing Siebel Clinical• Managed over a dozen Siebel Clinicalimplementations
  3. 3. Today’s AgendaTime Topic1:00-1:05 Welcome and Introductions1:05-1:15 What is a CTMS and Who Needs One1:15-1:25 Key Functions of a CTMS1:25-1:30 CTMS Selection Process1:30-1:35 System Types & ImplementationOptions1:35-1:45 Best Practices1:45-2:00 Q&A
  4. 4. What is a CTMS?• Web-based technology solution thatcentralizes the management aspectsof clinical trials• Results in streamlined businessprocesses and reduced time and costfor most trials• Enables informed decision-makingbased on real-time data• Simplifies historical reporting
  5. 5. Who needs a CTMS?• Any sponsor organization, clinicalresearch organization, or academicmedical center that:– Manages multiple clinical trials on anongoing basis– Wants to centralize and standardize themanagement of clinical trials and theassociated business processes– Wants to reduce study start-up time andassociated costs while increasing efficiencies
  6. 6. Key Functions of a CTMS• Investigator and Site Database– Cataloging the history and detailsof all individuals and organizationsassociated with clinical trials– Accelerating feasibility analysesduring investigator and site selection• Study Set-Up– Tracking essential documents– Planning for study expenses– Standardizing visit and payment schedules
  7. 7. Key Functions of a CTMS (cont.)• Site Management– Tracking of site budgets and investigatorpayments– Tracking of subjectenrollment and progression– Tracking of investigationalproduct and ancillary supplies– Tracking of protocol deviations andfollow-up issues– Tracking of site visits and monitoringreports
  8. 8. Key Functions of a CTMS (cont.)• Subject Tracking– Tracking overall subject enrollment– Tracking individual subjectvisits and activities– Tracking subject status at any time• Document Tracking– Tracking regulatory and other documentsbased on a study, site, individual orcompany– Tracking single documentsor document packages
  9. 9. Key Functions of a CTMS (cont.)• Financial Tracking– Monitoring expenses across a project– Tracking investigator payments based oncompleted activities or milestones– Tracking pass-through expensesat the site or study level• Reporting– Monitoring trip reports– Document tracking reports– Payment reports
  10. 10. Selecting a CTMS• Requirements– Organization gathers requirements from businessusers, IT and other stakeholders– Requirements are reviewed, finalized and prioritized• Demos– Vendor RFPs are distributed and responses received– Demos are scheduled by multiple vendors– Gap analyses are performed– Short list of best-fit systems is developed• Final Selection– Following further demos, additional requirementreviews and detailed sales discussions
  11. 11. Consideration: System Types• Standard CTMS:– Out-of-the-box system withoutorganization-specific customizations– Shorter implementation time, but may notmeet all of the organization’s requirements• CTMS Accelerator:– Pre-configured version of a standard CTMSthat includes commonly-requestedconfigurations and enhanced functionality– Can satisfy many of the organization’s keyrequirements without additional development– Less time and cost than a customized system
  12. 12. • Customized CTMS:– Standard or Accelerator systemthat is tailored to organizationspecific configurations and/orenhancements– Implementations average 9-12 months– Costs average around $1 million, dependingon the level of customization• Costs can be reduced by starting with an AcceleratorConsideration: System Types
  13. 13. Consideration:Implementation Options• In-House:– Hardware and software is owned,housed and operated by theorganization and maintained byits IT department• Hosted:– Hardware and software is housed andmaintained off-site by a third party
  14. 14. Consideration:Hosting Options• Dedicated Hosting:– You own the software and the servers, butthe servers are housed/maintained by adata center• Shared Hosting:– You own the software, but the servers areowned, housed, maintained by a datacenter and can be shared by others• Cloud Computing / SaaS:– You lease the use of the software andservers
  15. 15. Best Practices:Selection Process• Collect requirements from ALLstakeholders• Consider requirements beyondsystem functionality• Prioritize and define your evaluationscale– Consider whether you need allrequirements met immediately orwhether some can wait for a future phase
  16. 16. Best Practices:Implementation Strategy• “Big Bang”– All aspects of implementationcompleted simultaneously• Phased– Implementation is broken up into chunks,such as:BasicInstallationPoint Release forCustomConfigurationsData Migration &Retirement ofLegacy SystemsIntegrations
  17. 17. Best Practices:Before Implementation• Assemble your project team• Determine the tasks,deliverables, deadlines,and responsible resources• Create a scope control plan• Design your communication plan• Begin your SOP gap analysis• Begin analyzing theorganizational structure
  18. 18. Best Practices:During Implementation• Adhere to the Project Charter and thecommunication plan• Design your rollout plan• Design your training plan• Design your support plan• Involve users early and often• Create a “Data Standards” document• Mandate the use of CTMS
  19. 19. Questions?
  20. 20. ClosingThank you for attending!This webinar will be posted onwww.biopharm.comwithin 24