Improve Clinical Trial Processes With a Unified Platform
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The document discusses the challenges and inefficiencies in the clinical trial process, highlighting increasing costs and extended timelines for drug approval. It presents the journey of Idorsia in adopting a unified platform to enhance clinical trial management, focusing on improved collaboration and data connectivity. The report emphasizes the potential advantages of moving from disconnected point solutions to a comprehensive, integrated system for better operational efficacy in clinical research.
Improve Clinical Trial Processes With a Unified Platform
- 1. It’s Never Too Late - Improve Clinical Trial Processes With a Unified Platform February 28, 2019
- 2. 2Copyright © Veeva Systems 2019 Agenda Industry Perspective – Challenges and Opportunities 1 Idorsia’s Journey to a Unified Solution 2 Summary 3 Q&A 4
- 4. 4Copyright © Veeva Systems 2019 The Industry Has Become Less Efficient Across R&D 79% 81% 84% 88% 1980 1990 2000 2010 Percentage of All Drugs Entering Clinical Testing that FAIL to Receive Approval Capitalized Cost of Drug Development $1,044B $2,558B 2003 2018 • 26% Direct Costs • 18% Time-based • 56% Cost of Failure Source: Tufts CSDD Source: EvaluatePharma; William Blair & Wells Fargo Securities
- 5. 5Copyright © Veeva Systems 2019 Clinical Trials Take Longer Than 10 Years Ago A Typical Phase III Protocol (means) 2001–2005 2011–2017 % increase Total Cycle Time from Site Identification to FPI 25.6 weeks 29.1 weeks 14% Time from Patient Visit to Data Entry 6.9 days 8.1 days 17% Last Patient Last Visit (LPLV) to Database Lock 33.4 days 36.1 days 8% Source: Tufts CSDD
- 6. 6Copyright © Veeva Systems 2019 Key Challenges Silos Within Clinical Silos Across Development Increased Outsourcing Process Inefficiency Redundant Information IT Burden Usage Issues = Incompleteness Redundancy = Poor Quality Uninformed Decisions, Insights Lack of Coordination and Collaboration Data Completeness and Quality Disconnected Point Solutions
- 7. 7Copyright © Veeva Systems 2019 Does your organization utilize applications developed by third-party vendors in managing clinical studies? If yes, please indicate which are currently in use. (Q.3) Percent of total respondents, N=331 Today’s Clinical Trial Landscape There has been an explosion of technology
- 8. 8Copyright © Veeva Systems 2019 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. (Q.4) Percent of total respondents, N=331 But It’s Too Disconnected Top challenges related to application and process silos
- 9. 9Copyright © Veeva Systems 2019 Monitoring & Site Mgmt. Document Mgmt. Study Closeout Data Mgmt. Study Planning & Setup Site Activation And, It’s Proliferated …
- 10. 10Copyright © Veeva Systems 2019 Monitoring & Site Mgmt. Document Mgmt. Study Closeout Data Mgmt. Study Planning & Setup Site Activation … Throughout R&D IDMP Submissions Planning Regulatory Intelligence Study Planning and Setup Registration Tracking Publishing SOP Mgmt. Training CAPAs Validation Documents Manufactured Changes Document Mgmt. Safety Report Distribution Signal Detection SAE Reporting Case Intake Case Processing Document Mgmt.
- 11. 11Copyright © Veeva Systems 2019 We’re Relying More on Partners $38.3 $60.4 $71.6 $68.6 $10.4 $24.3 $43.1 $59.7 $5.9 $9.5 $12.7 $13.7 2000 2005 2010 2015 Internal Staff and Infrastructure CRO Services Investigative Site Services Share of R&D Spending Source: Tufts Center for the Study of Drug Development
- 12. 12Copyright © Veeva Systems 2019 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% EDC eCRF Portal IVRS Safety CTM S ePRO LM S eTM FeSource M obile ePRO Other Sites Smothered by Tech Which of the following tech, typically supplied by sponsors, are currently used at site Source: CenterWatch 2016; (n=252 sites) 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Somewhat well Not very well Very well Not well at all Extent to which available tech solutions are meeting site operating needs Lots of different tech pushed to sites from sponsors Most tech does not support site’s operational needs Tech does not support site operations and lacks interoperability
- 13. 13Copyright © Veeva Systems 2019 Key Opportunities for Clinical Trials and Development Platforms vs point solutions Connected data Cloud Reimagine processes Event-driven automation Change and implementation Shortening the distance within clinical and R&D Connecting ecosystem of partners CollaborationBetter ExecutionTechnology Simplification
- 14. 14Copyright © Veeva Systems 2019 Monitoring & Site Mgmt. Document Mgmt. Study Closeout Data Mgmt. Study Planning & Setup Site Activation But How Do We Go From This…
- 15. 15Copyright © Veeva Systems 2019 Monitoring & Site Mgmt. Document Mgmt. Study Closeout Data Mgmt. Study Planning & Setup Site Activation And This… IDMP Submissions Planning Regulatory Intelligence Study Planning and Setup Registration Tracking Publishing SOP Mgmt. Training CAPAs Validation Documents Manufactured Changes Document Mgmt. Safety Report Distribution Signal Detection SAE Reporting Case Intake Case Processing Document Mgmt.
- 16. 16Copyright © Veeva Systems 2019 Sponsors CROsSites …To This? UNIFIED & CONNECTED
- 17. Journey to Simplifying the Clinical Landscape
- 18. Idorsia Today >750Highly qualified professionals 10 >1 bn > 550State-of-the-art laboratory workspaces Compounds in the pipeline, with four in late-stage development Swiss francs in cash Improve clinical trial processes with unified platform | 28 Feb 201918 Multiple therapeutic areas CNS Cardiovascular Immunological disorders Orphan diseases
- 19. Legacy Systems Landscape Idorsia A “green field” with great time pressure and fixed deadline Transition Agreements (12 months) A Unique Opportunity Project & Resource Management Business & Corporate Systems Infrastructure & User Support eTMF CTMS eCTDEDMS EDC Statistical Computing Environment Data Analytics QMS Clinical Trial Portal Improve clinical trial processes with unified platform | 28 Feb 201919
- 20. Platform based and SaaS The Strategy Clinical & Quality Systems Scope Document Management Quality Management Project & Resource Management Clinical Operations Clinical Data Regulatory & Submissions CTMS & eTMF QMS EDMS EDMS & eCTD Functionality and Usability • Best fit to Idorsia user requirements • Minimal configuration no customization • User-friendly and intuitive • Connecting information in R&D Idorsia‘s IT strategy • One platform supporting a variety of functional areas • True Software as a Service • Compliant Improve clinical trial processes with unified platform | 28 Feb 201920
- 21. Making the impossible happen Our Journey’s Timeline and Scope 2017 2018 2019 J A S O N D J F M A M J J A S O N D J F M Program & Change Management Platform CTMS & eTMF (Clinical) EDMS (Regulatory & Quality) QMS (Quality Management) OtherClinical eCTD System Biometry Environment Data Analytics Platform & Tools Project & Resource Management System Drug Safety Systems Other Business & Corporate Systems Infrastructure & User Support Kick-off WS to go-live Ongoing Improve clinical trial processes with unified platform | 28 Feb 201921
- 22. A unified solution Highlights and User Experience Improve clinical trial processes with unified platform | 28 Feb 201922
- 23. CTMS • 180 users • 6 ongoing and all legacy studies eTMF • 180 users • 6 closed studies EDMS • 300 users • 50.000 documents Implementation & roll-out Benefits Of The Unified Platform Scope Highlights Streamlined approach to validation documentation, testing, operational procedures Minimal integration effort • Integrated eTMF/ CTMS, no technical interfaces required to align milestones or transfer documents • User provisioning/ SSO set up on platform level Experience can be applied across all applications MAR Improve clinical trial processes with unified platform | 28 Feb 201923
- 24. End User Experience Benefits Of The Unified Platform Highlights Ease of use • Same user interface and principles across all application • Ease of navigation and search functionality (filters and views) • Visual representation of documents and metadata in one view Seamless use of CTMS and eTMF, e.g. • Studies, sites, personnel only created once • Monitoring Visit Reports signed in CTMS and automatically in eTMF • Comprehensive progress reporting Cross-linking of documents between eTMF and EDMS Clinical Trial Management System (CTMS) Electronic Trial Master File (eTMF) Electronic Document Management System (eEDMS) Scope Highlights Improve clinical trial processes with unified platform | 28 Feb 201924
- 25. Maintenance and Support Benefits Of The Unified Platform CTMS/ eTMF • 310 users • 14 ongoing studies (w/o phase 1) EDMS • 300 users Reduced training effort • Users get quickly up to speed if trained on one of the Vaults • CRAs - 3 hours, Study Managers - 2.5 hours (eTMF and CTMS) Small support team working across the platform Streamlined release management • 3 major releases per year which can be run “silent” • New functionality implemented at own pace per application Streamlined vendor and contract management HighlightsScope Improve clinical trial processes with unified platform | 28 Feb 201925
- 26. • Strong dependency on one vendor requires solid risk assessment and a strategic partnership • Not all applications may be “best of breed” • Software as a service / cloud based - To be in line with the corporate IT strategy - Requires streamlined business processes adapted to the system to avoid customization Improve clinical trial processes with unified platform | 28 Feb 201926 Considerations!!
- 27. Document Management Quality Management Project & Resource Management Clinical Operations Clinical Data Regulatory & Submissions CTMS & eTMF QMS EDMS EDMS & eCTD Summary User Experience Implementation & Roll-out Maintenance & Support Improve clinical trial processes with unified platform | 28 Feb 201927
- 28. Questions
- 29. Thank You For more information, please contact: Jim.Reilly@Veeva.com LinkedIn: www.linkedin.com/in/jim-reilly