Implementing a New Clinical Systems Strategy
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Intersect ENT is a medical device company focused on advancing treatments for ear, nose, and throat conditions through innovative solutions. They face challenges with multiple protocol cycles, manual processes, and the need for greater efficiency, prompting the implementation of a unified clinical systems strategy using Veeva's Vault EDC. The company has achieved positive site feedback and aims for further unification and improvement in future clinical operations.
Implementing a New Clinical Systems Strategy
- 1. CONFIDENTIAL DELIVERING INNOVATION. WHERE IT’S NEEDED. Implementing a New Clinical Systems Strategy David Templeton – Clinical Systems Manager
- 2. Who Is Intersect ENT A medical device company dedicated to advance the treatment of ear, nose and throat (ENT) conditions through evidence-based innovation, and solutions for physicians to overcome clinical challenges and improve the quality of life for patients. 2
- 3. Who Is Intersect ENT 3 event 2 2009-2010 Pivotal study 105 patients 2006 Development begins PROPEL (device) 2011 FDA Approval 2014-2016 Study 2: 300 patients 2008 Development begins Sinuva (drug) 2017 FDA Approval 2013-2014 Study 1: 100 patients Founded in 2003 | 325+ employees today | Approx. 2 studies per year 2011-2012 Pilot studies 2014-2016 PROPEL Mini & Contour 160 patients
- 4. As a Medical Device Company What we face • Team members wear multiple hats • Multiple protocol cycles • Compressed timelines What we need • Greater efficiency • Quick, easy EDC builds • Intuitive solutions 4
- 5. Challenges 5 Manual processes Compressed study builds Payments EDC CTMS eTMF Payments
- 6. Two Main Vendor Approaches 6 • Sponsor chooses best fit of applications • Not forced into one vendor’s solutions • Integration is an additional cost and effort • Doesn’t always work as promised One Vendor • Promise of integrated applications • ROI prioritized over innovation • No consistency • Increased training Point Solutions
- 7. A New Approach: Unification 7 Applications on unified platform Same look and feel across all products Constant innovation
- 8. Why Veeva • Started with Vault PromoMats • Opportunity to automate clinical operations • Best of both approaches • Low-risk decision to try Vault EDC 8
- 9. Implementing Vault EDC 9 JuneMayAprilMarch July Project started Develop forms & rules protocol amendments UAT August PK Cohort in conduct phase Go live Protocol V1 Device study, 2 cohorts February Validation Database lock September
- 10. What’s Worked • Early adopter – influence product development • Common interface across all Vaults • Constant innovation • System works as expected • Positive site feedback/experience 10
- 11. Lessons Learned • Setting internal expectations about Early Adopter • Missing features we’ve become used to • Form statuses • Ad hoc reports • Exports on demand • “Hamster Wheel of Change” 11
- 12. Future Vision 12 • Improve unification between EDC and CTMS • Site payments • Improve site and user administration • Improve eLearning administration • Add medical device requirements • Device accountability • Imaging
- 13. In Summary • Desire to move away from stand-alone applications • Successfully implementing Veeva’s suite • Feel positive about the future of Veeva unification 13
- 14. Thank You 14