Cognizant Life Sciences - Pharmacovigilance CoE

• Pharmacovigilance (PV) CoE

Changing Dynamics for Global Life Sciences

Committed to Drug Safety Transformation –

Cognizant PV CoE

Life sciences companies are facing significant pressures due

to patent expiry, declining revenue growth, reduced margins

and complex regulations, thereby increasing the cost and

duration of drug development.

Increased drug safety stringency is driving life sciences

companies to embrace a proactive pharmacovigilance (PV)

strategy. PV organizations are aggressively adopting measures to

proactively detect and manage emerging safety risks. At the same

time, they are facing key challenges to ensure regulatory

compliance and cost reductions.

Key Challenges:

?Integrating emerging compliance requirements like REMS

(FDAAA) and RMPs (EU regulations) for Risk Management.

?Lack of proactive and effective compliance tracking.

?Adoption of proactive surveillance including signal

detection and monitoring.

?Maintaining uniformity and consistency across global PV

processes.

?Lack of actionable PV metrics.

?Enabling complete, high quality and on-time regulatory

submissions.

?Analyzing and integrating large volumes of safety data.

Our PV center of excellence (CoE) endeavors to help

organizations adopt and execute right PV strategy through its

end-to-end solutions and services. These offerings leverage

our vast experience in drug safety process consulting, IT

solutions implementation and PV process outsourcing to help

industry reduce regulatory and business risks. We are

committed to deliver tangible transformation experience for

your drug safety and PV operations.

We are uniquely poised to help global drug safety and PV

organizations perform better:

I. Cognizant's Pharmacovigilance Consulting Services

Our consultants have deep domain understanding, detailed

process knowledge and extensive industry experience to

provide:

?Pharmacovigilance Business Strategy.

?PV Maturity Assessment.

?PV Process Re-engineering and Optimization.

?Streamlining PV Process Automation.

?REMS/RMP.

?Transformation Strategy.

?Pharmacovigilance IT Strategy.

?PV IT Roadmap.

?Evaluation of PV COTS (Commercial Off the Shelf) systems.

?Delivery with Single End Objective: Transformed PV operations.

?Engagements driven by IT-BPO-consulting synergy as well as

cross-functional synergy across R&Dfunctions like clinical

data management, pharmacovigilance, medical writing,

statistical analysis and programming.

?Metrics-driven engagements leveraging Integrated

continuous process improvement methodology.

PV Consulting

PV IT Solutions PV KPO

Cognizant PV Solution Frameworks

Pharmacovigilance Center of

Excellence (PV CoE)

Pharmacovigilance (PV) CoE 1

Adverse Event Mgmt Solution over Cloud

AE & Trial Safety Data

Case ProcessingRegulatory

Submissions

INPUT CORE PROCESS OUTPUT

Program Management

AERS IT System

Transition QC/QA Training Security BCP/DRP

Benchmark SLAs Governance

Drug Safety Cloud Platform

Medical Contact Center Voice Platform

In-Maintenance Services

built Platform

Case Intake & Mgmt Quality Control Medical Reveiw Reporting

Core Foundation

Platform Services

Business Process

Pharmacovigilance (PV) CoE 2

II. Cognizant's Pharmacovigilance Knowledge Process

Outsourcing Services (KPO)

III. Cognizant's Pharmacovigilance IT Solutions and Services

We have an extensive experience delivering end-to-end

services in the area of Pharmacovigilance KPO. We employ 500-

plus associates across more than ten engagements including 5 of

top 10 global pharma corporations. Our PV KPO practice has rich

experience of handling annual volumes of more than 350,000

cases. We ensure metrics-driven delivery of business processes

from strategic global delivery locations across the U.S. India,

Europe, Argentina and China. This uniquely networked delivery

approach provides 24 X 7 coverage as well as on-shore, near-

shore & offshore advantages.

Our PV KPO Services include:

?24 X 7 Global Medical Contact Centers for case receipts.

?End-to-end Adverse Event case processing: Case intake and

triage, quality control and medical reviews.

?Case Analysis and Reporting (DSURs, PSURs, Aggregate,

custom reports).

?Drafting PSURs and Addendum reports, generation of line

listings.

?Appendices preparation and publishing as well as

regulatory submission.

?Scientific Literature Surveillance.

?Reconciliation of PV database with clinical database.

?Population Studies & Pharmaco-epidemiology Assessment.

We provide IT services across the entire PV value chain for the

top-most pharmaceutical and biotech companies of the

world. With 550-plus associates, the PV IT solutions team

brings along with it rich experience and expertise in clinical

and safety domains. Our PV IT consultants can help you

implement, enhance and maintain COTS and custom

solutions and services across the entire PV value chain. We

partner with leading vendors such as Oracle, Medidata and

Extedo to provide seamless services across various platforms

as well as all phases of the PV lifecycle. Our PV IT solutions and

services expertise includes:

?Designing & development of global safety data repository,

post migration & integration of safety data

?Design, development and implementation of AERS, signal

detection & integrated case receipt systems

?PSUR pre-filling & workflow implementation

?Implementation, validation, maintenance & upgrade of

COTS applications such as Argus Safety, ARISg, Clintrace,

TrackWise & Oracle AERS

?Integration of medical dictionaries with COTs applications

?Design, development & submission of regulatory,

operational, analytical & custom reports

IV. Cognizant PV Solution Frameworks

To leverage our rich experience, we have built reusable

solution frameworks for our services.

?Validated and up-to-date case processing platform in a

secure environment.

?Infrastructure hosted on cloud and maintained by Cognizant.

?Platform-integrated safety metrics that benchmark and track

PV process performance, efficiency and quality.

?Outcomes/Transactions based flexible pricing.

ASPIRE LITE - Safety data repository, signaldetection and reporting framework

?Proven, technology-independent solution that is now co-

marketed along with SAS.

?Substantial reduction in analysis, design and development

effort resulting in a cost benefit ranging from 15% to 30%.

3

?CARES Transition

Proven methodology with over 100-plus transitions; Connect, Assess, Re-design, Execute and Stabilize (CARES) transition ensures risk free transition from clients to Cognizant.

?Seamlessly Integrated Metrics

Cognizant ensures that all PV engagements have an integrated metrics measurement and reporting component. These well-defined metrics are standardized and benchmarked against operational best practices. The metrics are captured and accessed in near real-time through an interface that provides visual insights into the health of the engagement through dashboards, graphs, and charts in regular status reports. Typical metrics captured include:

sMean ICSR Turnaround Time (TAT).

sPending submissions for a drug.

sCost per ICSR.

sMean time for Medical Review.

sAccuracy % in Case Entry.

sMissing AEs in a Report.

Our “PV” projects have achieved 100% adherence in turnaround time for all types of serious adverse event cases.

?Quality Management

Cognizant develops unique and customized Quality Management Plan (QMP) for each engagement. The QMP consists of transactional Quality Control (QC) and comprehensive Quality Assurance (QA). The QMP leverages Six Sigma & lean methodologies with periodic internal Quality Audits to ensure quality and compliance of each engagement.

sAccuracy of data entry process increased from 97% to 99% by introducing scanning and tracking database options for case assessments and quality review of cases.

sAccuracy improved for PSUR writing process to 95% for simple to complex reports.

?Continuous Process Improvement

Cognizant leverages Six Sigma & lean concepts for continuous process improvements to reduce process variations and improve process quality and timeliness. This approach enables us to take preventive measures to avoid re-occurrence of defects and ensure high productivity with quality deliverables in the steady state of the engagement.

sImproved productivity by 18 to 20% for case processing through automation.

?Innovation & Ideation

Cognizant is committed to provide business transformation in all our strategic client relationships leveraging ideation and innovation concepts. Most of the ideas are implemented as “Kaizen” or Lean projects or DICE (Digital Idea Center) that allows the collection, review and implementation of innovation ideas from the operations and management teams.

?Training

wCustomized plans for each engagement focusing on each role and experience level. The plans are designed to ensure continuous trainings for all skills required for a successful engagement.

wTraining programs are delivered through class room sessions lead by expert trainers, e-learning; interactive learning mode like memory aids, podcasts, videos etc.

wCertified vendors & partners to deliver specialized training.

Pharmacovigilance (PV) CoE

Proven Cognizant levers for delivering operational excellence in clinical data services engagements

CARES Transition

Training Quality

Management

Continuous Process

Improvement

Seamlessly Integrated

Metrics

Innovation &

Business Transformation

Our Proven Levers for Delivering Operational Excellence in Pharmacovigilance Engagements

APPRAISE - COTS evaluation

Understand current stateof PV at Client site

Develop Future Vision for PV at Client site

Generate Business Requirements

Prioritize Requirements

Package Evaluation Process

Evaluate Package Features Evaluate Vendor Evaluate TCO Verify Customer Acceptance

Package Demo/VendorQuestionnaire

Response

Vendor Questionnaire

Response

VendorQuestionnaire

Response/Discussions

Vendor ReferenceChecks

Package Evaluation Summary

Dis

co

ve

rG

ath

er

Re

qu

ire

me

nts

Ev

alu

ate

Se

lec

t

?AHP-based tool to evaluate multiple

alternatives based on client-specific

business requirements.

?Extensive domain and application

knowledge built through experience

evaluating CTMS, EDC, AERS, signal

detection, patient profile viewer and

product complaints handling.

© Copyright 2012, Cognizant. photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is subject to change without notice. All other trademarks mentioned herein are the property of their respective owners.

All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any means, electronic, mechanical,

World Headquarters

500 Frank W. Burr Blvd.

Teaneck, NJ 07666 USAPhone: +1 201 801 0233Fax: +1 201 801 0243Toll Free: +1 888 937 3277Email: inquiry@cognizant.com

India Operations Headquarters

#5/535, Old Mahabalipuram RoadOkkiyam Pettai, ThoraipakkamChennai, 600 096 IndiaPhone: +91 (0) 44 4209 6000Fax: +91 (0) 44 4209 6060Email: inquiryindia@cognizant.com

UK Headquarters

1 Kingdom Street

Paddington Central

London W2 6BD

Ph: +44 207 297 7600

Fax: +44 207 121 0102

Email: infouk@cognizant.com

PV Expertise Delivered Consistently

Industry Thought LeadershipWe are actively involved in top industry forums such as

CDISC and DIA, evangelizing evolving standards.

perspective and white papers on Pharmacovigilance have

About CognizantCognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world's leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50 delivery centers worldwide and approximately 145,200 employees as of June 30, 2012. Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.

Life Sciences Practice at Cognizant

Cognizant Life Sciences has extensive relationship with 27 of the world's top 30 pharmaceuticals, 9 of the top 10 Biotech and 12 of the top 20 Medical Devices. Whether it's driving process improvements to your clinical operations, increasing sales & marketing effectiveness, meeting regulatory requirements or enhancing drug safety, Cognizant is redefining the way companies benefit from and experience global services. We provide services in such areas of the businesses as application development, support and maintenance, CRM, EDMS, CDMS, CTMS, ERP, DW/BI, Integration, Infrastructure, Knowledge Process Outsourcing, Pharmacovigilance, Biometrics, Regulatory Compliance and Validation support across all GxPs, Business Technology Consulting, Strategic Consulting and a full range of software testing. Our strategic partners ensure that we can provide deep competencies to service the unique needs of life sciences industry. With Cognizant as your global partner, you have access to the best talent in the world: over 11000 + professionals working in more than 50 global delivery centers. Get the partnership your company deserves. Get Cognizant at or email us at www.cognizant.com nquiry@cognizant.com .i

been featured and published in many leading pharmaceutical

journals. Our extensive participation in these forums and

journals allows us to better serve our clients and the overall

PV marketplace.

?Argus

?Oracle AERS

?ArisG

People

Platforms

Key

Perfo

rman

ce

Indic

ators

Partnerships

?

.

?112,000+ medical terms coded with 99.5%+ accuracy.

?2,200+ aggregate reports, scientific and regulatory medical writing documents supported per month.

Approx. 30,000 cases processed per month across engagements

?1,000+ safety professionals across consulting, IT and KPO.

?PV Center of Excellence to develop and retain talent.

?Partnership with Symogen for certification course approved by WHO-UMC, Royal College of Physicians and ISoP.

?Platinum Partner?Co-development of strategic Oracle projects.?Beta testing of multiple product lines.

?Platinum Consulting Partner.?Substantial investments to build solutions-targeted

SAS practices.

?Training partnership for customized PV certification course for continuous education of PV resources.

?Partnership for implementing, maintaining and supporting PcV manager, a drug safety management software solution.

Oracle -

SAS -

Extedo -

Symogen -

? ClinTrace

?TrackWise

?Custom