This document provides information on ROLLINGDICE's multilingual call center solutions and PV247 pharmacovigilance software. ROLLINGDICE offers multilingual call center services through its subsidiary Fusion BPO Services, which has facilities in North America, India, the Philippines, and El Salvador. PV247 is a hosted pharmacovigilance system that provides drug safety software and eliminates the need for large upfront costs compared to traditional systems.

1. FOR YOUR
GLOBAL PV PLUS VANTAGE SOLUTIONS
A ROLLINGDICE Operating Company
ROLLINGDICE PRODUCT PARTNER
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2. Multilingual
Services
• Multilingual call center facilities
• PCI, ISO 9001, ISO 27001, HIPAA-compliant
Global facility centers
• Agents trained and experienced in medical
process
• Appropriate accent in terms of reception
quality
Pharmacovigilance
software
• ISO 9001-2008 accredited Quality
Management System
• 21 CFR Part 11 compliant
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3. Introducing
FOR YOUR MULTILINGUAL
CALL CENTER SOLUTIONS
A ROLLINGDICE Operating Company
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4. Fusion At a Glance
Fusion BPO Services is a ROLLINGDICE Operating company which delivers call center, outsourcing and
consulting services from 5, 24/7 contact centers.
• Serves multi-lingual English, French, Spanish,
Italian, German and more.
• PCI, ISO 9001, ISO 27001, HIPAA-compliant
• Privately held
• Included among top outsourcing providers in IAOP’s
Global Outsourcing 100 list.
• Widespread industry experience and offerings
across various verticals
• Disaster Recovery Plan ensuring Business Continuity.
Better Relationships Quick Turnaround Customized Services
Founded 2003 Revenue~ $35M Employees 1700North American Corporation
Flexible engagement model
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5. Fusion’s Global Facilities
 All sites interconnected from 2 locations.
 Any call can be sent to any agent.
 Centralized business support from India
 Global IT support 24/7
Draper, Utah
Focus: Retail &
Direct Response
Montreal
Focus: Retail,
Home Services, Tech
India
Focus: Order processing
I.T.
Sales
Quality
WFM
RTA
Reporting
CRM
Philippines
Focus: Sales & CS
London
Sales Office
Santa Elena, El Salvador
Focus: Spanish, Retail
Location Seats
Draper, Utah 250
Montreal, Canada 240
Kolkata, India 650
Manila, Philippines 260
Santa Elena, El Salvador 300
1,700
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6. Our Core Offerings
Telecom
Intellectual
Property
Health & Beauty
Financial services
Retail
Inbound/Outbound Call
Center Services
Back Office Support
Customer Care
Help Desk Solutions
Technical Support
Market Research & Surveys
USA
Canada
El Salvador
Philippines
India
Pharmacovigilance
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7. Recognitions & Corporate Membership
Member of the National
Association of Software and
Services Companies
(NASSCOM).
Member of the Business
Processing Association of the
Philippines (BPAP).
Member of the Professional
Association for Customer
Engagement (PACE).
Member of Electronic
Retailing Association (ERA).
Member of Direct
Response Marketing
Alliance (DRMA).
Certified with Payment Card
Industry's Data Security standards
(PCI-DSS).
Member of Data Security
Council of India (DSCI).
International Organization
for Standardization
Fusion BPO Services included
among the top outsourcing
providers in IAOP’s Global
Outsourcing 100 list.
O’Currance ranked 24th in
TMC’s among the Top 50
Teleservices Agencies in the
world.
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8. 1 single Platform - 4 Comprehensive Solutions for Life Sciences
Introducing
FOR YOUR GLOBAL PV SOLUTIONS
ROLLINGDICE PRODUCT PARTNER
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9. PV 247 is a specialist software house developing drug safety software for both the
human and veterinary sectors.
We supply:
– In-house installations
– Hosted solutions
Established in 1996 under the name Assured, now part of the The Ennov Group which
is a ROLLINGDICDE Product Partner ,
– Also supplying software solutions for clinical trials, regulatory affairs and quality
The current customer list includes
– Leading global companies in the animal health industry
– Many human drug companies
– Various regulatory authorities (including FDA CVM / USDA / Health Canada & CFIA)
Ennov has offices in:
– US: Research Triangle Park, New York City, Durham, NC and San Francisco, CA
– UK: Near Cambridge
– FR: Paris, Poitiers and Bordeaux
PV 247 At a glance
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10. Global Utilization
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11. The benefits of an electronic pharmacovigilance database are clear.
A comprehensive system will provide the following fundamentals:
1. An interface to collect case data, including mechanisms to:
-Validate data at the point of entry
-Make controlled assessments and apply standardized coding
-Manage a quality process for timely submission of required reports
2.A function to generate paper and electronic reporting files, for submission via:
-A gateway (US & EMA)
-EV-WEB trader (EMA)
3.A secure repository of all submitted case data, for future:
-PSUR generation, using built in reports
-Local data analysis and trending, using built in utilities
The traditional PV database
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12. So a comprehensive PV system is desirable, but…
– Initial implementation costs are perceived as being prohibitive
– Implementation and on-going maintenance and support resources are often unavailable
in smaller organizations
o IT infrastructure and personnel
o System validation expertise
• Historically the implementation of a traditional PV database has meant a lengthy (and
costly) consultancy process
The traditional PV database
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13. The traditional PV database option is often seen as the solution for a
large global organization only…
– Yet the pharmacovigilance obligations remains the same regardless of:
o The number of products
o The volume sold
o The number of cases received
– Including requirements like mandatory electronic reporting to FDA
o (from June 2015)
• A hosted “Software as a service” (SaaS) solution offers an alternative
approach…
The traditional PV database
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14. Benefits of a Hosted System
• Everything that a conventional PV database can offer
– Comprehensive data capture
– Comprehensive reporting functionality
– Data storage for later periodic reporting, trending and analysis
• Without the system overheads
– Minimal setup costs
– Minimal capital investment
– Minimal local IT support requirements
– Minimal on-going maintenance cost / resource requirements
• Plus
– Secure access from anywhere over the internet
> Hosted solution = Application + Service
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15. The limitations of a hosted system
• Sensitive data is retained off-site
– Data security issues
– Issues with service continuity if another solution is adopted
– Mitigated by:
o Use of appropriate system / access security
o Use of purpose built data centers
o Availability of data in recognized standard format
• Software configuration / customization
– Desire to adopt custom configuration not usually offered by the hosted provider
– It should be noted that regulations drive industry towards one position
• Potential supplier failure
– A risk for any business
– Mitigated by selecting a proven, established, specialist supplier
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16. PV247 is a hosted pharmacovigilance system
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18. • Security and quality is delivered through
– Use of restricted server access, defined users accounts, 2-factor authentication
– Strict adherence to an ISO 9001-2008 accredited Quality Management System
– Software designed to be operated in compliance with 21 CFR Part 11
• The PV247 database is provided from a fully serviced ‘state of the art’ data center
– Options to host either in UK or US
• Takes care of the IT aspects, delivering:
– Minimal downtime (servers are monitored 24/7)
– System resilience (idle back-up servers ready for disaster recovery)
– Offsite backups (every 3 hours, with overnight tape to secure off-site location)
– System upgrades (including MedDRA dictionary) provided at no extra cost
– Email / telephone support (depending upon package selected)
Security and Compliance
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19. • PV247 offers a straight-forward implementation pathway
– Online registration and system creation
– System is pre-configured to meet standard requirements
– Software is pre-validated
• Additional validation materials are supplied with no additional charge for companies
wishing to execute full ‘system’ validation
– Website contains various online training videos to complement the user-friendly
interface
• PV247 is flexible, we currently have hosted customers ranging from:
– 2 user system with < 100 cases / year
– 15 user system managing > 10,000 cases / year
– PV-Works is implemented globally with > 250 users and > 1 million case records
• PV247 is fully scalable
– Various implementation packages available, at different price points
Implementation insights
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20. Prolonged Relationship with Fusion’s PLUSVANTAGE
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21. THANK YOU
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