rollingdice-pv-solution

FOR YOUR GLOBAL PV PLUS VANTAGE SOLUTIONS

A ROLLINGDICE Operating Company ROLLINGDICE PRODUCT PARTNER

1ROLLINGDICE CLIENT INTERNAL

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


Introducing FOR YOUR MULTILINGUAL CALL CENTER SOLUTIONS

A ROLLINGDICE Operating Company


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 1700 North American Corporation

Flexible engagement model


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


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


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.


1 single Platform - 4 Comprehensive Solutions for Life Sciences

Introducing FOR YOUR GLOBAL PV SOLUTIONS

ROLLINGDICE PRODUCT PARTNER


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


Global Utilization


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


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 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…



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


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


PV247 is a hosted pharmacovigilance system


• 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


• 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


Prolonged Relationship with Fusion’s PLUSVANTAGE


THANK YOU


rollingdice-pv-solution

Documents