ArisGlobal - Corporate Overview

WE BRING THE FUTURE TO LIFE

Corporate Overview

4

3

2

1

QUESTIONS

BUSINESS SOLUTIONS

BUSINESS CHALLENGES

OVERVIEW

Agenda

Why ArisGlobal

Trusted

• 8 Health Authorities using ArisGlobal Solutions

• 30 out of 50 large pharma

• Ongoing commitment by ArisGlobal to Life

Sciences industry

• Proven track record in all areas of regulatory

compliance including PV

Innovative

• First to market with Fully E2B R3 Compliant & xEVDMP/IDMP Ready solution

• First PV solution to have cognitive capabilities on the market

• Achieved 20% reduction in case processing time from day one

• First to introduce cloud to PV market

Proven• 25+ years of Experience

• 200+ Current Clients

• 100+ customers on ArisGlobal Cloud

- Largest PV solution on GxP complaint cloud

• 30 Customers on ISP-based, multi-tenant platform

3ARISGLOBAL CORPORATE OVERVIEW |

Health Authority Customers

ANSM

FRANCE

HC MHPD SC DPSC

CANADA

HPRA

IRELAND

MPA

SWEDEN

NOMA

NORWAY

FDA

U.S.A.

FIMEA

FINLAND

SFDA

SAUDI

ARABIA

• Agence Nationale de

sécurité du Médicament et

des Produits de Santé

• An tÚdarás Rialála Táirgí

Sláinte

• Statens legemiddelverk • Finnish Medicines Agency

• Health Canada

- Santé Canada

• Läkemedelsverket • U.S. Food and Drug

Administration

• Saudi Food and Drug

Authority


Market-Leading Customers


Business Solutions across the Medical Product Value Chain


Clinical Drug Development

Phase II Phase IIIPhase I

Pre

Clinical

Product Life Cycle Management

Marketing / Phase IV

Product

Launch

Clinical

R&D

Establish initial safety and

efficacy profiles

Refine indications,

demographics and safe

use for initial launch

Regulatory

Authority

Extend and maintain reach

of product portfolio

Rapid reaction to

regulatory requests

Medical Affairs

Messaging

Deliver the right message

to the right stakeholders at

the right time

Increase transparency and

timeliness

Safety

Surveillance

Improve patient safety

Manage safety profile

Common LifeSphere Platform

Maturity of the Regulatory Compliance Process

We help life science

companies improve

with an innovative

approach to

understanding their

processes with the

“Maturity Model”

Pro

cess M

atu

rity

and

Busin

ess V

alu

e

Optimized

Level 4Are we optimized for change and responsive to new market conditions?

Strategic

Level 3Have we automated processes to ensure compliance and reduce rick?

Efficient

Level 2Are we using standard processes and tools?

Tactical

Level 1Are we compliant?

Key Process Areas

Safety Regulatory Clinical Medical Affairs


Challenges

8

Transitioning

to E2B (R3) by

November

Improve

process ease of

understanding

Lacking

completeness

in global

compliance

ARISGLOBAL CORPORATE OVERVIEW |

Solutions

LifeSphere

10

Regulatory

Affairs

• Submission Planning &

Approval Tracking

• Regulatory Submissions

• IDMP Compliance xEVMPD

Medical

Affairs • Medical Information

• Products Complaints

• Call Center

• Content Management

• HCP and Patient Portal

Pharmacovigilance

& Safety

• Case Receipt & Triage

• Case Management

• Safety Submissions

• Submission Tracking

• Signal Detection &

Management

• Veterinary Safety

• Mobility

• Central Coding

Clinical

Development

• Clinical Trial

Management

• Electronic Trial

Master File

• Trial Disclosure

• Investigator Portal

• Electronic Report

Distribution

• Electronic Data

Capture

• Patient Reported

Outcomes

• Clinical Supply

Chain Management

• Risk-Based

Monitoring

• Central Coding

Clinical Drug Development Pre-Launch Product Life Cycle Management

ARISGLOBAL CORPORATE OVERVIEW |

Pharmacovigilance & Drug Safety

ARISGLOBAL CORPORATE OVERVIEW | 11

• Full compliance with international

PV directives and regulations

• Industry-standard platform

configuration incorporating PV

best practices

• Adaptable to organizations of

any size

• Measurable reductions in

case-processing times

• Inspection and audit ready

• Integrates with 3rd party

applications including EDC

LifeSphere Safety DatabaseTM Case processing and reporting

LifeSphere Safety DatabaseTM Japanese case processing

agXchange ESMTM Electronic submissions gateway

Inbound Case Receipt and TriageTM Inbound adverse event triage

LifeSphere Submissions TrackingTM Outbound submissions tracking

LifeSphere Reporting and AnalyticsTM Data analytics

LifeSphere Signal and Risk ManagementTM Signal detection and risk management

LifeSphere Central CodingTM Centralized coding

LifeSphere Vet SafetyTM Veterinary safety reporting

Regulatory Affairs


• Complete end-to-end regulatory solution

• Clear and quick visibility of all phases

of regulatory submissions

• Compliance gateway to regulations

and standards

• Enables cross-functional effectiveness

and compliance via information sharing

• Facilitates collaboration with affiliates

and partners

• Ongoing compliance to information

standards and regulations

• Effectively plan and track dossiers

and submissions

LifeSphere RIMSTM Cloud-based regulatory affairs solution

RegisterTM Regulatory tracking system

Regulatory Submissions TrackingTM Regulatory submissions

LifeSphere IDMPTM IDMP product portfolio management

Clinical Development


• Unified & Integrated CTMS/CDMS

comprised

of 9 mission-critical modules

• Each solution can be deployed

independently or

as part of entire suite

• Powerful integration capabilities

enables seamless use of external

applications

• Holistic view to study data enables

real-time reporting and decision

making

• Mobile enabled

LifeSphere CTMSTM Extended clinical trial management

LifeSphere eTMFTM Electronic file master file

LifeSphere EDCTM Clinical data management

LifeSphere Trial DisclosureTM Trial disclosure

LifeSphere SUSAR ReportingTM Electronic report distribution

LifeSphere eCOATM ePro/COA

LifeSphere RTSMTM Supply management

agRegistryTM Patient enrollment

LifeSphere Central CodingTM Central coding

agWorldTM Clinical portal

Medical Affairs


• Rapid, accurate and up-to-date

customer communications

• Unified platform of medical

information,

product complaints, adverse

events and

medical communications

• Field enablement with full self-

service capabilities

• Single platform with reduced

cost of ownership

LifeSphere MITM Medical information management

LifeSphere Product ComplaintsTM Product complaint handling

LifeSphere Mobile MATM HCP & patient portal

LifeSphere CMSTM Content management

LifeSphere Call CenterTM Call center

LifeSphere Intake and TriageTM Adverse event triage

Appendix

Process Maturity

We help life science

companies improve

with an innovative

approach to

understanding their

processes with the

“Maturity Model”

Pro

cess M

atu

rity

and

Busin

ess V

alu

e

Optimized

Level 4Are we optimized for change and responsive to new market conditions?

Strategic

Level 3Have we automated processes to ensure compliance and reduce rick?

Efficient

Level 2Are we using standard processes and tools?

Tactical

Level 1Are we compliant?

Key Process Areas

Safety Regulatory Clinical Medical Affairs


Copyright Policy


©2017 ArisGlobal LLC. All rights reserved. LifeSphere Safety Database, LifeSphere Signal and Risk Management, LifeSphere Intake and Triage, agXchange ESM, LifeSphere

Submissions Tracking, LifeSphere Reporting and Analytics, LifeSphere Central Coding, LifeSphere Vet Safety, LifeSphere IDMP, LifeSphere RIMS, LifeSphere CTMS, LifeSphere

eTMF, LifeSphere EDC, LifeSphere Investigator Reporting, LifeSphere Investigator Portal, LifeSphere Trial Disclosure, LifeSphere eCOA, LifeSphere RTSM, LifeSphere Product

Complaints, LifeSphere Web Portal, LifeSphere Mobility, LifeSphere Medical Information, LifeSphereCMS, LifeSphere Investigator Reporting, agSignals, agComposer, agConnect,

agWorld, agSIR and the @risglobal® logo are trademarks or registered trademarks of ArisGlobal in the US Patent and Trademark Office and other jurisdictions. Other marks may be

trademarks or registered trademarks of their respective owners.

The information you see, hear or read on the pages within this presentation, as well as the presentation’s form and substance, are subject to copyright protection. In no event, may

you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of

ArisGlobal. Trademarks, service marks, and logos (collectively the “trademarks”) displayed on the pages within this booklet, are the property of their respective owner. No license or

right pertaining to any of these trademarks shall be granted without the written permission of ArisGlobal (and any of its global offices and/or affiliates, including ArisGlobal UK Ltd.,

ArisGlobal GmbH, ArisGlobal KK). ArisGlobal reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights.

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ArisGlobal - Corporate Overview

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