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Driving Clinical Trial Efficiency in an Outsourced Model
This document discusses driving clinical trial efficiency through an outsourced model and moving towards a unified clinical model. It describes the current state of disparate clinical technologies and siloed processes that cause challenges. Moving to a unified model with one platform, one version, and streamlined data flow can provide benefits like improved visibility, oversight, decision making, and faster trial execution. Integrating applications and exposing electronic trial master files to partners can also boost collaboration. Leveraging data through reports and dashboards allows for ongoing monitoring and compliance.
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Driving Clinical Trial Efficiency in an Outsourced Model
- 1. Driving Clinical TrialEfficiency in an Outsourced Model Presenter: Shad Ayoub, Veeva Outsourcing in Clinical Trials West Coast February 13, 2019 Burlingame, CA
- 2. 2Copyright © VeevaSystems 2018 Objectives Discuss today’s current state, challenges, and the industry’s desire to move towards a unified clinical model Discuss opportunities to transform trial execution through greater collaboration How to leverage data for oversight and compliance Understand the difference between Integrated and Unified
- 3. 3Copyright © VeevaSystems 2018 Clinical Trial Process Today Study Planning and Set-Up Site Activation Monitoring and Study Management Data Management Study Closeout Document Management (TMF) Site Activation Tool eTMF Tool CTMS CTMS EDC
- 4. 4Copyright © VeevaSystems 2018 The Veeva Unified Clinical Operations Survey examines the life sciences industry’s progress in reducing system and process complexity to improve study execution. This research aims to understand the drivers, benefits, and barriers of a unified clinical operating model. Veeva Unified Clinical Operations Survey
- 5. 5Copyright © VeevaSystems 2018 Today’s Clinical Technology Landscape Does your organization utilize applications developed by third-party vendors in managing clinical studies? If yes, please indicate which are currently in use. Source: Veeva 2018 Unified Clinical Survey, Q3 Percent of total respondents, N=331
- 6. 6Copyright © VeevaSystems 2018 Top Challenges Related to Application and Process Silos What are the biggest challenges, if any, your organization faces in utilizing the clinical applications identified in question 3? (e.g., CTMS, EDC, eTMF, etc.) Select all that apply. Source: Veeva 2018 Unified Clinical Survey, Q4 Percent of total respondents, N=331
- 7. 7Copyright © VeevaSystems 2018 87% of clinical leaders taking action to unify clinical systems and processes Industrywide Move to A Unified Clinical Model Source: Veeva 2018 Unified Clinical Survey, Q6 Percent of total respondents, N=331 Does your organization have an initiative underway to better integrate/unify clinical applications in Q3?
- 8. 8Copyright © VeevaSystems 2018 Top Drivers for Unified Clinical Operations Visibility and Oversight Faster Trials Study Quality Productivity Collaboration 77% 67% 62% 51% 49% Source: 2018 Veeva Unified Clinical Operations Survey
- 9. Transform Trial Executionthrough Collaboration
- 10. 10Copyright © VeevaSystems 2018 • Security − Site users should only see content that applies to their site or has been directly shared with them • Simplicity − UI for sites should be a simple, secure means to exchange content − Document re-use across multiple studies can reduce document collection needs • Task-based Collaboration − Site users usually interact with Sponsors/ CROs for upload/authoring and acknowledgement of tasks Expose Your eTMF to Partners Site / Sponsor / CRO Collaboration with eTMF
- 11. 11Copyright © VeevaSystems 2018 • Consistency − Document exchange is performed the same regardless of the users involved • Contemporaneousness − Documents do not disappear into the void (e.g., email, fax, FedEx/UPS, local drive, etc.) − Reports on completeness and timeliness are more accurate and meaningful • Traceability of the Life of a Document − All activity on a document in the eTMF is captured • Reporting − Ability to report on activities performed in the eTMF Benefits eTMF Collaboration
- 12. 12Copyright © VeevaSystems 2018 Passive vs. Active Operating Models • Paper documents / scanning • Study teams do not regularly access the TMF • TMF is not integrated with other clinical systems • No/few manual KPIs or metrics PASSIVE ACTIVE • Electronic documents managed in system • Sites, CROs, and sponsor have eTMF access • TMF is integrated with other eClinical systems • Real-time KPIs and metrics used for active management
- 13. Leverage Data forOversight, Compliance, and Decision-making
- 14. 14Copyright © VeevaSystems 2018 The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s). INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2), November 2016
- 15. 15Copyright © VeevaSystems 2018 The Power of Reports and Dashboards • Reports and dashboards can be used as early as study planning and throughout the life of a study • Continuous visibility and better oversight of trial activities Study Administration TMF Planning Document Collection Document Processing Closeout & Archival
- 16. 16Copyright © VeevaSystems 2018 Historical Forward Looking Custom How long did it take to approve documents? Which documents are approaching expiration? How long does it take to resolve issues during Review? How many documents have been reviewed and approved? Timeline Management Where are the bottlenecks in a process? What is the duration documents spent in each workflow? TMF Completeness How many iterations are needed with each site prior to completion? QC, Review, and Approval Cycle Times What items need attention? E.g. Overdue Approvals How many documents are in the Approved State? How many times has a specific user viewed an approved document? Inspection Readiness What is the average time to Approval? What Can Reports / Dashboards Provide?
- 17. Integrated versus Unified What’sthe Difference?
- 18. 18Copyright © VeevaSystems 2018 Integrated versus Unified Title Integrated Unified Technology Disparate technologies Multiple versions One platform One version User Experience Different User Interfaces Multiple Logins One login Unified experience Data Flow Disconnected processes Broken flow of documents and data Streamlined processes Seamless flow of documents and data Visibility Limited Complete
- 19. 19Copyright © VeevaSystems 2018 The Impact of Disparate Technologies Higher Integration and Maintenance Costs Reduced Ability to Make Quick Timely Decisions Slow and Error-prone Manual Processes
- 20. 20Copyright © VeevaSystems 2018 Interim Monitoring Visit Today
- 21. 21Copyright © VeevaSystems 2018 Interim Monitoring Visit With Unified Suite
- 22. 22Copyright © VeevaSystems 2018 Site Activation Monitor & Site Mgmt. Data Mgmt. Document Mgmt. Study Planning Study Closeout The Unified Clinical Trial Process One Unified Solution One Intuitive User Experience One Complete View
- 23. Thank You To readthe 2018 Annual CRO Report visit: http://bit.ly/AnnualCROReport18