Regulatory Information Management A single system or a happy family?
RIM – what are we trying to solve The customer’s requirements The vendor’s view from outside
What we have seen at our customers Case studies and examples
A little about Generis
Agenda
RIM – what is the problem we are solving
SOPs
Submissions Registration Tracking
Product Supply
eTMF
CTMS
At the same time – we are chasing…
It’s all about the user: Fast
Personalised Simple
Cloud
Enterprise solution not spot solutions
But give me specific use case functionality
Seamlessly integrate with multiple systems (RIM)
RIM – what do the vendors propose?
“We solve your business case”
• No solutions talk to each other • Your data is duplicated everywhere • Inefficiencies
“We do everything”
• Some things done well, some not • Migrate everything to one system • Single point of failure
eTMF
Subm
issi
ons Labeling Pl
anni
ng
Registration
eTMF Submissions
Labeling Planning
Publishing Registration
…
Integration-as-configuration
The ideal…
The business key to RIM is to allow users to access and manage the information through a single user interface. The IT key to RIM is to use existing systems as much as possible to avoid data migrations and a single point of failure.
Con
tent
Man
agem
ent
Mas
ter D
ata
Man
agem
ent
Submission Planning & Tracking
Clinical Trial Management System
Create, review, approve content
Submission Publishing
Registration Tracking
Labeling Management
Product Supply
Manufacturing Controls
Pharmacovigilance
Archival
Customer case study 1: Safety – PV integration
• CARA/ Documentum is used for document initiation
and sending over to PV system • CARA/ Documentum receives PV documents
associated with cases for archival. • Processing of documents (such as redacting) is done
in CARA using Documentum permissions and version controls.
• Medical Records, workflow checks, and validations built into the process
• Completed case information is received from PV system and documents are moved into a completed folder.
• Automated QC process for moving input records to QC check folders
• Intake Worklist – Includes metadata around patient cases along with the file
• Metadata for cases include data points such as Country, Data, Product, Event
• Patient cases are created in the PV system • Document Intake area created to receive input files
from Documentum so files don’t have to be entered directly into the PV system
• Sending files directly to the PV system • Documents are added to either a new case or a
follow up to an existing case • Same document from CARA content store is used in
multiple PV Cases for faster processing times and increased in efficiency
• CARA/ Documentum security privileges used for document content
CARA / Documentum PV System
Customer Case Study 2: Planning, docs and tracking
• Planning outline used to build Virtual Docs (CARA
Structures) programmatically • Workflows and dependencies can be established on
placeholders, which then have documents authored / associated with them
• As dossier is built, information on the status can be pushed back to the planning & tracking tool
• Plan the dossier in the planning tool
• Track the progress in the tracking tool and prepare for publishing
CARA / Documentum Planning and Tracking
Customer Case Study 3: Safety Data Exchange Agreements
CREATION
APPROVAL / THIRD PARTIES
TRACKING & INTEGRATION
•Create contracts from templates •Push metadata into Word documents to populate the contract with e.g. automatically generated contract numbers, counterparty information
•Utilise the integrations with PharmaDoc Annotation and PharmaDoc Generator to facilitate the review of contracts •Create a package of multiple documents, combine using PharmaDoc ClientPublisher
•Use the CARA Forms capability to create an input form e.g. for Business Partner Evaluations, QA questionnaires and more •Dynamically render the form contents to PDF with PharmaDoc Generator
•Share contracts with external counterparties through use of the email / portal to send •Receive back counterparty edits via manual or automated upload to the Staging Area (extracting from emails)
•Utilise the CARA internal workflows for approval, including eSignature •Display signatures as added pages on the contract using the CARA DocSecure module
•Use the CARA integration with DocuSign (see separate datasheet) for digital signature, including individuals who are not system users e.g. third parties / externals
•Build CARA Reports to show contracts or other information status by country, month, group, product or other variables •Get automated alerts when contracts are due to expire and trigger workflows
•CARA Dashboards – show information from inside CARA and from external systems in single reports including graphing •Measure and track performance over time without need for separate reporting software
•Output information directly into a PSMF or in a form ready for manual inclusion
Customer Case Study 4: Medical Information
Many cycles of draft publishing add to the timeline, as it has to be coordinated between authors and publishers
Author publishing often done “quick and dirty” for review processes, and the output not valid for final publishing, which further reduces quality and increases timelines
SOLUTION Allow authors to do concatenations in Word within CARA to get
Word output for collaboration / co-authoring Allow authors to submit (through custom button in CARA) a
structure to PharmaDoc Publisher to get e.g. report-level output for final review
Customer Case Study 5: Publishing by authors
Generate QR code using CARA web or mobile
Print from web or mobile Fix to e.g. lab equipment Scan code and access
document in a single click (no searching, printing etc)
Mobile QR Codes
Navigate / search by picture
Integration-as-configuration
How to make a happy family
The business key to RIM is to allow users to access and manage the information through a single user interface. The IT key to RIM is to use existing systems as much as possible to avoid data migrations and a single point of failure.
Con
tent
Man
agem
ent
Mas
ter D
ata
Man
agem
ent
Submission Planning & Tracking
Clinical Trial Management System
Create, review, approve content
Submission Publishing
Registration Tracking
Labeling Management
Product Supply
Manufacturing Controls
Pharmacovigilance
Archival
A bit about Generis
Our Clients
OVER 300,000 LICENSED USERS
Life Sciences • 3M Healthcare • Abbott Pharmaceuticals • Aegerion Pharmaceuticals • Agios Pharmaceuticals • AstraZeneca • Bayer • Bayer Crop Science • Biogen • Blue Cross Blue Shield • Bristol-Myers Squibb • Cambridge Biomedical • Fresenius Kabi • Gilead Sciences • Hawaii Medical Services • Johnson & Johnson • Kadmon Pharmaceuticals • MedImmune
Life Sciences • Merck KGaA • Mylan Pharmaceuticals • Novartis Pharma • Novartis Animal Health • Otsuka Pharmaceuticals • Pfizer • Pierre Fabre • Roche • UCB • WebMD
Engineering • BHP Billiton • Pratt & Whitney
Government • City of Sacramento • Miami-Dade County • State of North Carolina • New South Wales Railcorp • US Department of
Homeland Security
Oil & Gas / Chemical • Chevron • Covestro • Dow Corning • MEG Energy • Suncor • Total Oil
Insurance & Financial • ATB Financial • Fannie Mae • Gen Re • Hannover Life Re • MFS • Scottish Re • VISA
Media • QVC Television • Walt Disney Studios
Consumer • Sargento Foods
Top reasons for CARA
Fast Easy to use “Find my Stuff” - Problem solved
Easy integrations Configurable & “Configurable
Customization” User Experiences
CARA “RapidDeploy” Packages
CARA is enterprise platform Build any configuration for any department / use case
We have developed “pre-configured packages” “Template” configuration to start your own, save time Industry Best Practices
SOPs / Quality GxP / Change Control Human Resources Legal Regulatory
Affairs (CTD)
IT / Validation Transmittals Correspondence & Commitment
Labeling
Training Pharmacovigilance
(ARGUS, ARISg) Safety Data Exchange
Agreements eTMF
Generis and Planet Pharma Solutions signed a partnership this year to: Provide enhanced support for Generis products in Japan through
Planet Pharma Provide enhanced support for Planet Pharma products in North
America and Europe through Generis Provide a powerful set of products from Planet Pharma integrated into
the Generis CARA product
About our partnership
Thank you
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