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.

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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