Your next RIM solution - 3 key considerations for your move

© 2019 Cunesoft GmbH www.cunesoft.com
3 Key Considerations for
Your Move
RIM
Your Next RIM Solution:
1

Q&A Session
Why Companies Move to New RIM Solutions
The 3 Key Considerations of Any Move
Migration
Configuration
The Future
Conclusion
Introducing Cunesoft
Index
RIM3
2
1
2

Q&A Session
Migration
Configuration
The Future
Conclusion
Index
RIM3
2
1
3

© 2019 Cunesoft GmbH www.cunesoft.com© 2019 Cunesoft GmbH www.cunesoft.com
„Regulatory peace of mind“
Jim
Nichols
Chief Operations
Officer
Headquarters: Munich, Germany
Regional Offices: Bangalore, Princeton, Birmingham
Industry Focus: Regulatory Software for Life Sciences
Venture Partners: HTGF, Bayern Kapital, Occident Group
Corporate Facts Global Life Sciences Customer
4

Q&A Session
Migration
Configuration
The Future
Conclusion
Index
RIM3
2
1
5

Why Change?
Change happens when the pain of
staying the same is greater than the
pain of change.
6

The Obvious Reasons
Older, highly customized software cannot fit into
today’s landscape
Legacy systems don’t match today’s real-life
information management needs
Annual maintenance costs grow to surpass the
value
7

The Greater Potential Benefits of a Better RIM Solution
Faster Time to Approval
RIM
Benefits
Optimized Revenue Opportunity
Greater Efficiencies
Improved Planning & Tracking
Better Health Authority Communications
Global Compliance with Current & Future Needs
8

Industry Has Spoken
Gens and Associates 2018 World Class RIM Survey of 69 Companies
9

The Promise of Regulatory Information Management (RIM)
Comprehensive Regulatory Information Management (RIM)
will help life sciences organizations effectively and
efficiently drive the development, capture, dissemination,
control and management of regulatory-focused content
throughout the product lifecycle.
Confidence in Data
Quality
Timely & Accurate
Reporting
Greater Overall
Efficiency
Compliance With
New Requirements
10

POLL
11

Let’s Describe FirstRIM
12

RIM & Its Fit In the Landscape
13

Q&A Session
Migration
Configuration
The Future
Conclusion
Index
RIM3
2
1
14

The 3 Key
Considerations
15

#MIGRATION - Consolidation is key
Where is everything?
Who owns the original
information?
Who owns the new
information?
Are some sources
non-existent?
Are some sources
unstructured?
What will be your new
governance model?
16

Sourcing Data Mining Staging Transforming Loading
EXTRACT ENRICH
Data Mapping
Data Mining
NLP Extraction
Consolidation
EVOLVE
#MIGRATION - Consider several steps
Submissions
RA Database
ERP
SharePoint
Documentum
Substances /
GSRS
MedDra
EV Codes
Old RIM
Others
Structured
data sources
Unstructured
data sources
External
references &
dictionaries
Global Affiliates
RIM Staging
Merge & Enrich
Apply Data Rules
Data QC Process
Master Data
Cleansing
Standardization
Match & Merge
MDM
repository
DB
RIM System
Product Data
Data Factory
Registration Mgmt.
Submission Mgmt.
XEVMPD / IDMP
eCTDv3 / eCTDv4
Authority Correspondence
Reporting
17

#CONFIGURATION - Configure – Don‘t Customize
Easier to implement
Easier to adapt
Easier to validate
Easier to revise
Interface
Information
Processes
Adaptation
18

Capture information in a way that is relevant to
you & your business
Combine best practices with specific internal
needs
#CONFIGURATION - Request Personalization
19

#CONFIGURATION - Product versus Registrations Relation
Capture information in a real-world structure & hierarchy
20

Standardize processes while offering global visibility
Enable workflow-driven processes and supporting automation
#CONFIGURATION - Challenge your own processes
21

Be responsive with
on-demand &
scheduled reports
Quickly find important
information for
internal & external
queries
#CONFIGURATION - Be able to answer any questions quickly
22

#FUTURE - Compliance today and tomorrow
xEVMPD
eCTD v3
NOW
IDMP
eCTD v4
NEXT
PQ/CMC?
POSSIBLY
ISO
11615
ISO
11616
ISO
11239
ISO
11238
ISO
11240
Medicinal product
information
Pharmaceutical dose forms,
units of presentation, routes of
administration and packaging
Units of
measurement
Pharmaceutical
product
information
Substances
23

#FUTURE - Increasing importance of controlled vocabulary
These operational benefits should have a positive
impact on public health and safety.
Benefits of SPOR services
Increase data quality and simplification
Supply regulatory data only once
Elimination of data silos
More efficient regulatory decision making
Improved interoperability
Operational savings and efficiencies
24

#FUTURE - Consider artificial intelligence
Intelligent Process Automation
Structured Content Methods
Natural Language Processing
Automated Content Generation
“Once your all your data is
structured, make benefit of it
and apply predictive analytics”
25

#FUTURE - Automating Regulatory SubmissionsCAPTURETRIGGERAUTOMATE
26

SPL
#FUTURE – Leveraging Predictive Analytics
Company Core Data Sheet - CCDS
Changes
Affiliate 1
Affiliate 2
Affiliate n
Componentized CCDS
27

POLL
28

Q&A Session
Migration
Configuration
The Future
Conclusion
Index
RIM3
2
1
29

In Conclusion…
30

Avoid Common Pitfalls
Common Mistakes
Failing to engage the lines of business and business
users at the outset
Absence of data governance policies and
organizational structure
Poor data quality in legacy systems
Neglecting to validate and redefine business rules
Failure to validate and test the data-migration process
Team entrusted with migration project lack industry
best-practices experience
Team relies too much on the tools of the job
Cross-object dependencies
Attempting to go live in one ‘big bang’
Budget overruns due to inadequate scoping or
preparation at the start
RIM
FDA
EMA
31

Why Change?
Change happens when the pain of
staying the same is greater than the
pain of change.
32

Q&A Session
Migration
Configuration
The Future
Conclusion
Index
RIM3
2
1
33

Your Questions
34

Jim Nichols
Email: jim.nichols@cunesoft.com
Tel: +1 609-955-3468
eCTD Submissions Regulatory DMS
Become a happy customer !
Data Lifecycle
Management
SOP Managment Regulatory Master
Data Management
Contact us
35

Your next RIM solution - 3 key considerations for your move

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