The document discusses Generis's Intelligent Content Services Platform and CARA software. It provides an overview of CARA's capabilities for regulatory information management, submissions management, and other regulatory and clinical processes. It highlights CARA's flexibility and ability to support multiple use cases across the product lifecycle from development through commercialization. Examples of large life sciences companies using CARA for regulatory information management and submissions are also provided.

1. The Intelligent Content
Services Platform
Unlock your vaults to get
seamless information flow

2. 2Confidential: Do not use or distribute externally without written permission from Gens and Associates
• Generis has a significantly higher percent of “pushing industry” or innovating opinions
than the provider average
• Generis is one of only 2 providers* (out of 33) with no “declining” views among
providers with at least 10 participant opinions
2
What is your opinion "generally" of the following
RIM software providers?
2018 World
Class RIM
Study
(n = 69)
* The other provide with no
decline was Micro Systems

3. 3
Development Clinical Regulatory Safety
CARA Life Science Platform
IDMP / SPOR / xEVMPD
Quality / GxP / SOP / QMS
eTMF
R&D / Regulatory Submissions / eCTD
Regulatory for Medical Devices (DHR, DMR, DHF)
Pharmacovigilance
Safety Data Exchange Agreements (SDEA)
Medical Information / Medical Inquiries
Regulatory Correspondence
Labelling / Artwork
Sales & Marketing
Submission Planning & Tracking
PSUR / Educational Tools / SABR etc
Corporate (Legal, IT, Human Resources)
Registration / Applications / Events
R
R
R
R
R
R
R
R
R
= RIM / Regulatory
Information Management
R

4. RIM Process flow in CARA
Create product
Create Regulatory
Application(s)
Create Regulatory
Event(s)
Create Submission(s)
Correspondence /
Commitments
Close EventsRegister
Latest Approved
Versions
Create product objects,
and manage them in
CARA as the Master Data
Management System
Create individual
applications which can be
for multiple products /
markets
From an application,
automatically generate
individual regulatory
events and assign them
Create a submission
package of documents
automatically based on
the submission plans
Find the most elusive
thing of all: what is the
latest approved document
for a particular market?
Register products on each
market and track the
registration while tracing
through to source documents
Close events and
associated documentation
once they are health
authority approved
Receive and respond to
regulatory correspondence
and manage associated
commitments

5. The key to successful RIM – tie data to documents
Data
Regulatory daily business processes
Documents
Controlled
Vocabularies
(e.g. Dosage form,
Indication)
Product
Vocabularies
(e.g. Product,
study, packaging)
RIM Process
(e.g. Events,
Assemblies,
Activities
Management of company-specific data
values
Product Family
Global Product
Medicinal
Product
Packaged
Product
Substance
Nonclinical
Study
Clinical Study
Management of core data values including
IDMP / SPOR information as required
Dosage Form
Dosage
Strength
Route of
Administration
Indication
Market
Site
Organisation
Pacakge Item
Species
Unit of
Measurement
Unit of
Presentation
etc
Global
submission
assemblies
Local
submission
assemblies
Applications
Application for authorization
in a particular market
Authorisations
Authorization in a particular
market(s)
Events
Plan for submission in a
number of market(s)
Activities
Implementation of the event
in a particular market

6. 6
Key Business ToolsKey Repositories
Core Enterprise Workspace
Content Management
Data Management
Product Information Management
Submission Management
Case Management
Internal & External Collaboration

7. Configured Solutions
Preconfigured with
industry best practices
and regulatory
requirements
Customers can modify
it but this means
changing perhaps 5-
10% instead of building
a new system from the
start
Customer Generis or customer Generis
URS
UAT
FRS
Installation
Qualification
Operation
Qualification
Migration
Qualification
Validation Plan
Validation Report
Test Plans, Test
Reports
Validation

8. Publishing via partner Lorenz – full traceability from source to output

9. GlobalAssembly(withActions)NationalAssembly
Plan/Initiate Author Distribute
Deviation
Check
Author
Review Approve
Translate
Review Approve Submit Manage
Create new
component
Version
Exisiting
Content
Add Existing
Content
Replace
Placeholder
Manage
supporting
documents
Create
Placeholder
Create
multiple from
template
Distribute to
market
Acknowledge
receipt
Copy for new
Event
Review
Document
Approve
Document
Innovation I: Assembly and Process Management

10. Steady State New Event – Change to Shelf Life in Stability Zone IV New Steady State
NationalProcessGlobalProcess
Core Assembly A
Approved
National
Assembly A(DE)
National
Assembly A(US)
National
Assembly A(TH)
National
Assembly A(PE)
Authorisation
A(DE)
Authorisation
A(US)
Authorisation
A(TH)
Authorisation
A(PE)
Core Assembly B
Draft
Core Assembly B
Approved
National
Assembly B (TH)
National
Assembly B (PE)
Application B
(TH)/ Submission
Seq 1
National
Assembly B(TH)
Application B
(PE)/ Submission
Seq 1
National
Assembly B (PE)
National
Assembly B(PE)
National
Assembly B(PE)
Application B
(PE)/ Submission
Seq 2
Authorisation
B(TH)
Authorisation
B(PE)
Core Assembly C
Draft
Core Assembly B
Approved
National
Assembly A(DE)
National
Assembly A(US)
Authorisation
A (DE)
Authorisation
A(US)
National
Assembly B(TH)
National
Assembly B(PE)
Authorisation
B(TH)
Authorisation
B (PE)
Innovation II – Assemblies and Events

11. XML submissions - xEVMPD / SPOR / ICH E2B R3
Capture Data Create XML
Submit to
Gateway
Handle
response
Done Done June 2020 Done
ICH E2B R3
(Safety)
Done July 2020 July 2020 DonexEVMPD
Done July 2020 July 2020 DoneSPOR

12. CARA CLOUD
Geography of choice
World
Class
Security
“New” CARA – Cloud or in-house
VIP Service
Standard multi-tenant

13. CARA Cloud
Standard multi-tenant
Upgrades automatically every quarter
Upgrades available every quarter, customer can
delay or skip releases to suit (up to 1 year)
Not available as VPN Available as VPN
VIP Service
Shared services
(application server, rendering etc)
Dedicated services
(application server, rendering etc)
Dedicated Repository Dedicated Repository

14. About Us
Headquartered in Sarasota,
FL
Offices in UK & Poland
Founded in 1998
60% of Top 20 Life Science
customers
Over 470,000 users globally
Sarasota,
USA (HQ)
London, UK
Bielsko Biala,
Poland
Frankfurt,
Germany
Tokyo,
Japan

15. 15
Some of Our Customers

16. Why multiple use cases?
One User
One License
The cost of CARA is significantly lower than
competitors’ ”per repository” model

17. Top down
Regulatory Submissions and
Regulatory Information
Management (RIM)
How AbbVie’s vision of a Future
State for efficient regulatory
operations led to the selection
of CARA to support the process

18. The Problem at AbbVie
How do I know what product is registered where?
What is the impact of any change I make in core information or
individual markets?
How can I efficiently re-use information to avoid rework and
inconsistencies, including answering the same regulatory
authority question multiple times in different way?
How to I track my business across the globe including all Affiliates
from the top down to enable better planning and product strategy
management?

19. The Solution – CARA for RIM and Regulatory
CARA was selected by AbbVie in 2019 after a wide-ranging review of the tools on the market.
It was selected for
• the flexibility to be configured to user requirements
• the performance
• the usability from an end user perspective
The program set out to integrate core business processes and state-of-the-art technology to
drive more streamlined and efficient ways of working.
The aim was to help AbbVie achieve seamless execution of regulatory activities by replacing a
set of stand-alone RIM tools with an integrated solution, to manage
• regulatory planning
• tracking
• registration
• content management
The purpose was to Instantly Know What is Registered Where – and use that to drive
efficiencies and compliance in new submissions, HA correspondence and commitments and
to bring Affiliates and Distributors into the core of the regulatory activities.

20. Documents in context
of application but
with re-use across
applications
Plan, build, publish, view
and archive in a common
set of integrated tools
(Lorenz docuBridge and
CARA)
What is registered where?
What is impacted if I make
any change?
How do I track what
Affiliates submit / deviate
from on the core
Company product and
application data
Regulatory authority
information
Right First Time…
Data
Management
Document
Management
Dossier
Management
Impact
Assessment
A submission is a submission is a submission…

21. 21
“Your response time and delivery has been
phenomenal (not just good!)”
Marie Yunis, Project Manager for
CARA implementations at MFS
“A very robust, stable, and highly
configurable product”
“The responsiveness of Generis to suggestions for
enhancements and the remarkable turn-around time in which
we were given the updates tipped the scales“
“You actually listened to what we wanted”
“Their company’s leadership and team were
knowledgeable and responsive throughout the
process “
“Senior leaders from across the AZ business
were genuinely taken by surprise by the extent
of the positive reaction to Cara, several
commenting that they had never before seen
such a turnaround in user sentiment from a
system improvement initiative, nor one
accomplished so seamlessly and smoothly.”
Ashley Birch, Global Head, Information
Strategy Systems and Analytics, GRAPSQA
“We did a comparison of D2 vs. CARA and
found CARA to be far superior in the features
as well as value.”
Barb Buschmann, IT Director,
Sargento

22. 22
End-to-End Life Sciences

23. 23
End-to-End Life Sciences

24. 24
End-to-End Life Sciences

25. 25
End-to-End Life Sciences