Contenu connexe Similaire à Eisai EMEA: Laying the foundation for centralised medical information management (1) (20) Plus de Veeva Systems (20) 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
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
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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
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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!
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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
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…
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
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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
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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
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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
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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
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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
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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
Notes de l'éditeur Japanese Company
HQ in Tokyo 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 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