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Laying The Foundation for Centralised
Medical Information Management
30th June 2020
Elizabeth Rance, Head of Medical Information EMEA
David Robertson, Business Solutions Director EMEA
Webinar Topics
1
Introduction to Eisai
Eisai Medical Information
Business / Technology Challenges
Why MedComms?
Project Overview
Key Considerations
Success Metrics
Copyright © Eisai
MORE THAN
10,000
EMPLOYEES
WORLDWIDE
MAIN FOCUS IN
ONCOLOGY &
NEUROLOGY
HQ IN TOKYO
EMEA HQ IN UK
JAPANESE
PHARMA
COMPANY
Introduction to Eisai
Copyright © Eisai 2
Eisai EMEA Medical Information
EMEA Team at Hatfield support 12 affiliates in addition to partners
Responsible for UK/IE Medical Information
Authoring standard response content that is shared and adapted
locally
Handling EMEA escalations and authoring ad-hoc / custom
responses
Copyright © Eisai 3
Business / Technology Challenges
No centralised
system
Couldn’t scale
across the region
Inflexibility to meet
business needs
Lack of traceability
and audit trail
Lack of consistency
Inefficient and lack
of transparency
Duplication of
tracking content
escalations
Compliance risk
Copyright © Eisai 4
What Next?
5
Business buy
in – Business
Case for
Change
Engaging with
Procurement
Exploring
Potential MI
Solutions
Vendor
Assessments:
IT Security,
Quality &
GDPR
Copyright © Eisai
Why MedComms
Copyright © Eisai 6
Intuitive, efficient system
Complete and accurate tracking
Robust compliance and audit trail
Familiar technology platform
Synergy with Vault PromoMats i.e. One login to
access Vault
Consolidation of content repositories
Reporting and insights – visibility across
markets, country, product, category
Laying The Foundation
Get the
fundamental
things right
in HQ
Onboard
affiliates –
Harmonise
processes
across the
region
Longer
term vision
– Connect
the wider
digital
ecosystem
MODERNISE OPTIMISE TRANSFORM
We are here
For Medical Information Transformation
Copyright © Eisai 7
Project Objectives – Phase 1
• Core case handling
• Content management
• Reporting/insights
Get the fundamentals right
first
Speed!
Copyright © Eisai 8
Key Project Considerations – Phase 1
Inbound
Channels
Responding
Channels
Medical Library
Content
Content
Lifecycle
Cover Letters
& Templates
SLAs / SOPs
AEs & PCs Reports &
Dashboards
Roles &
Permissions
Content / Data
Migration
UAT /
Validation
Copyright © Eisai 9
…
Speed
Phase 1 of Implementation for HQ
Implementation Timeline
November December January
Planning | Solution Design | Configuration | Testing | Document Preparation | Training & Deployment
Kick Off Go-Live
Copyright © Eisai 10
Project Objectives – Phase 2
• HQ first
• Then EU5 + Russia
• Other 7 affiliates later
Phased project approach
• Local business processes and
regulations
• Change Management
Country Specific Requirements
Copyright © Eisai 11
…
Key Project Considerations – Phase 2
Inbound
Channels
Responding
Channels
Medical Library
Content
Content
Lifecycle
Cover Letters
& Templates
SLAs / SOPs
AEs & PCs Reports &
Dashboards
Roles &
Permissions
Content / Data
Migration
UAT /
Validation
Regional
Harmonization
Local
Requirements /
Regulations
Escalations &
Case
Assignments
Ad-hoc
Content
Requests
Data Privacy Roles &
Permissions
2.0
Copyright © Eisai 12
Adapting to Local Needs – Maintaining a Central Core
E.g. Local Product Alignment
• Meeting local requirements for
capturing Product information
• Product Name, generic vs.
Brand name, indication,
lowercase/uppercase
• Need to maintain unified
reporting
Copyright © Eisai 13
Centralised Reporting
?
Adverse Events & Product Complaints
• AE/PC reporting
previously handled
manually via external
forms
• Form consolidated into
MedComms in Phase 1
• Now traceable and
reportable from a single
location
Copyright © Eisai 14
Data Privacy
• Access and visibility a
key consideration for
Phase 2
• See only what you
need to see
• Restricted access to
requests only
• Maintains value of
EMEA reporting
15Copyright © Eisai
Reports & Dashboards
• Full visibility into cases
and status for local
country
• Filterable by various
dimensions – regionally
aligned Products
• Will increase visibility
across the regions once
roll out complete –
including content uptake
and usage
Copyright © Eisai 16
Success Metrics – Phase 1
Project delivered
successfully and
on time
Delivered at
speed – requiring
collaboration
across teams
Created a single
source of truth for
Medical
Information
Unlocked
complete and
accurate tracking
Access to a robust
and compliant
audit trail
Instant visibility
and traceability of
cases, workloads,
documents etc.
Copyright © Eisai 17
Success Metrics – Phase 2
Satisfying Local
Requirements and
Regulations
Centralised System for the
EMEA Region
EMEA Wide Reporting
Increased Efficiency and
Compliance
Copyright © Eisai 18
Q&A

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Eisai EMEA: Laying the foundation for centralised medical information management (1)

  • 1. Laying The Foundation for Centralised Medical Information Management 30th June 2020 Elizabeth Rance, Head of Medical Information EMEA David Robertson, Business Solutions Director EMEA
  • 2. Webinar Topics 1 Introduction to Eisai Eisai Medical Information Business / Technology Challenges Why MedComms? Project Overview Key Considerations Success Metrics Copyright © Eisai
  • 3. MORE THAN 10,000 EMPLOYEES WORLDWIDE MAIN FOCUS IN ONCOLOGY & NEUROLOGY HQ IN TOKYO EMEA HQ IN UK JAPANESE PHARMA COMPANY Introduction to Eisai Copyright © Eisai 2
  • 4. Eisai EMEA Medical Information EMEA Team at Hatfield support 12 affiliates in addition to partners Responsible for UK/IE Medical Information Authoring standard response content that is shared and adapted locally Handling EMEA escalations and authoring ad-hoc / custom responses Copyright © Eisai 3
  • 5. Business / Technology Challenges No centralised system Couldn’t scale across the region Inflexibility to meet business needs Lack of traceability and audit trail Lack of consistency Inefficient and lack of transparency Duplication of tracking content escalations Compliance risk Copyright © Eisai 4
  • 6. What Next? 5 Business buy in – Business Case for Change Engaging with Procurement Exploring Potential MI Solutions Vendor Assessments: IT Security, Quality & GDPR Copyright © Eisai
  • 7. Why MedComms Copyright © Eisai 6 Intuitive, efficient system Complete and accurate tracking Robust compliance and audit trail Familiar technology platform Synergy with Vault PromoMats i.e. One login to access Vault Consolidation of content repositories Reporting and insights – visibility across markets, country, product, category
  • 8. Laying The Foundation Get the fundamental things right in HQ Onboard affiliates – Harmonise processes across the region Longer term vision – Connect the wider digital ecosystem MODERNISE OPTIMISE TRANSFORM We are here For Medical Information Transformation Copyright © Eisai 7
  • 9. Project Objectives – Phase 1 • Core case handling • Content management • Reporting/insights Get the fundamentals right first Speed! Copyright © Eisai 8
  • 10. Key Project Considerations – Phase 1 Inbound Channels Responding Channels Medical Library Content Content Lifecycle Cover Letters & Templates SLAs / SOPs AEs & PCs Reports & Dashboards Roles & Permissions Content / Data Migration UAT / Validation Copyright © Eisai 9 …
  • 11. Speed Phase 1 of Implementation for HQ Implementation Timeline November December January Planning | Solution Design | Configuration | Testing | Document Preparation | Training & Deployment Kick Off Go-Live Copyright © Eisai 10
  • 12. Project Objectives – Phase 2 • HQ first • Then EU5 + Russia • Other 7 affiliates later Phased project approach • Local business processes and regulations • Change Management Country Specific Requirements Copyright © Eisai 11
  • 13. … Key Project Considerations – Phase 2 Inbound Channels Responding Channels Medical Library Content Content Lifecycle Cover Letters & Templates SLAs / SOPs AEs & PCs Reports & Dashboards Roles & Permissions Content / Data Migration UAT / Validation Regional Harmonization Local Requirements / Regulations Escalations & Case Assignments Ad-hoc Content Requests Data Privacy Roles & Permissions 2.0 Copyright © Eisai 12
  • 14. Adapting to Local Needs – Maintaining a Central Core E.g. Local Product Alignment • Meeting local requirements for capturing Product information • Product Name, generic vs. Brand name, indication, lowercase/uppercase • Need to maintain unified reporting Copyright © Eisai 13 Centralised Reporting ?
  • 15. Adverse Events & Product Complaints • AE/PC reporting previously handled manually via external forms • Form consolidated into MedComms in Phase 1 • Now traceable and reportable from a single location Copyright © Eisai 14
  • 16. Data Privacy • Access and visibility a key consideration for Phase 2 • See only what you need to see • Restricted access to requests only • Maintains value of EMEA reporting 15Copyright © Eisai
  • 17. Reports & Dashboards • Full visibility into cases and status for local country • Filterable by various dimensions – regionally aligned Products • Will increase visibility across the regions once roll out complete – including content uptake and usage Copyright © Eisai 16
  • 18. Success Metrics – Phase 1 Project delivered successfully and on time Delivered at speed – requiring collaboration across teams Created a single source of truth for Medical Information Unlocked complete and accurate tracking Access to a robust and compliant audit trail Instant visibility and traceability of cases, workloads, documents etc. Copyright © Eisai 17
  • 19. Success Metrics – Phase 2 Satisfying Local Requirements and Regulations Centralised System for the EMEA Region EMEA Wide Reporting Increased Efficiency and Compliance Copyright © Eisai 18
  • 20. Q&A

Notes de l'éditeur

  1. Japanese Company HQ in Tokyo
  2. Couldn’t scale the system - Requests from across the region to scale Communication challenging No centralized system Compliance challenges – lack of audit trail Inefficient and lack of transparency Consistency Synergy with PromoMats Duplication of tracking content escalataions
  3. Synergy Intuitive Familiar platform One login to access Vault Compliance – audit trail Accurate tracking MI, AE, PC Response documents only stored in one place Previously in the database, local storage drive, and shared drive for affiliates Reporting – across markets, country, product, category