ArisGlobal - Corporate Overview
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Transcript of ArisGlobal - Corporate Overview
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WE BRING THE FUTURE TO LIFE
Corporate Overview
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4
3
2
1
QUESTIONS
BUSINESS SOLUTIONS
BUSINESS CHALLENGES
OVERVIEW
Agenda
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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 |
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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
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Market-Leading Customers
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Business Solutions across the Medical Product Value Chain
6ARISGLOBAL CORPORATE OVERVIEW |
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
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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
7ARISGLOBAL CORPORATE OVERVIEW |
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Challenges
8
Transitioning
to E2B (R3) by
November
Improve
process ease of
understanding
Lacking
completeness
in global
compliance
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Solutions
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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
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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
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Regulatory Affairs
ARISGLOBAL CORPORATE OVERVIEW | 12
• 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
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Clinical Development
ARISGLOBAL CORPORATE OVERVIEW | 13
• 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
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Medical Affairs
ARISGLOBAL CORPORATE OVERVIEW | 14
• 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
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Appendix
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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
16ARISGLOBAL CORPORATE OVERVIEW |
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Copyright Policy
ARISGLOBAL CORPORATE OVERVIEW | 17
©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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Thank You