Cognizant Life Sciences - Pharmacovigilance CoE

1 Pharmacovigilance (PV) CoE. Cognizant life Sciences - Pharmacovigilance CoE. Changing Dynamics for Global life Sciences ? Delivery with Single End Objective: Transformed PV operations. life Sciences companies are facing significant pressures due ? Engagements driven by IT-BPO-consulting synergy as well as to patent expiry, declining revenue growth, reduced margins cross-functional synergy across R&Dfunctions like clinical and complex regulations, thereby increasing the cost and data management, Pharmacovigilance , medical writing, duration of drug development. statistical analysis and programming. Increased drug safety stringency is driving life Sciences ? Metrics-driven engagements leveraging Integrated companies to embrace a proactive Pharmacovigilance (PV) continuous process improvement methodology. 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 PV Consulting compliance and cost reductions.

2 Key Challenges: ? Integrating emerging compliance requirements like REMS. (FDAAA) and RMPs (EU regulations) for Risk Management. Pharmacovigilance ? Lack of proactive and effective compliance tracking. Center of ? Adoption of proactive surveillance including signal detection and monitoring. Excellence PV IT Solutions (PV CoE) PV KPO. ? Maintaining uniformity and consistency across global PV. processes. ? Lack of actionable PV metrics. ? Enabling complete, high quality and on-time regulatory Cognizant PV Solution Frameworks submissions. ? Analyzing and integrating large volumes of safety data. I. Cognizant 's Pharmacovigilance Consulting Services Committed to Drug Safety Transformation Our consultants have deep domain understanding, detailed process knowledge and extensive industry experience to Cognizant PV CoE. provide: Our PV center of excellence (CoE) endeavors to help organizations adopt and execute right PV strategy through its ? Pharmacovigilance Business Strategy.

3 End-to-end solutions and services. These offerings leverage ? PV Maturity Assessment. our vast experience in drug safety process consulting, IT ? PV Process Re-engineering and Optimization. solutions implementation and PV process outsourcing to help ? Streamlining PV Process Automation. industry reduce regulatory and business risks. We are ? REMS/RMP. committed to deliver tangible transformation experience for ? Transformation Strategy. your drug safety and PV operations. ? Pharmacovigilance IT Strategy. We are uniquely poised to help global drug safety and PV ? PV IT Roadmap. organizations perform better: ? Evaluation of PV COTS (Commercial Off the Shelf) systems. Pharmacovigilance (PV) CoE 1. II. Cognizant 's Pharmacovigilance Knowledge Process IV. Cognizant PV Solution Frameworks Outsourcing Services (KPO) To leverage our rich experience, we have built reusable We have an extensive experience delivering end-to-end solution frameworks for our services. services in the area of Pharmacovigilance KPO.

4 We employ 500- plus associates across more than ten engagements including 5 of top 10 global pharma corporations. Our PV KPO practice has rich Adverse Event Mgmt Solution over Cloud experience of handling annual volumes of more than 350,000. cases. We ensure metrics-driven delivery of business processes INPUT CORE PROCESS OUTPUT. from strategic global delivery locations across the India, Europe, Argentina and China. This uniquely networked delivery approach provides 24 X 7 coverage as well as on-shore, near- Case Processing shore & offshore advantages. AE & Trial Regulatory Safety Data Program AERS IT Submissions Our PV KPO Services include: Management System ? 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. Business Case Intake &. Process Mgmt Quality Control Medical Reveiw Reporting ? Case Analysis and Reporting (DSURs, PSURs, Aggregate, Platform Drug Safety Medical Contact In-built Platform custom reports).

5 Services Cloud Platform Center Voice Platform Maintenance Services Core Transition QC/QA Training Security BCP/ Benchmark Governance ? Drafting PSURs and Addendum reports, generation of line Foundation DRP SLAs listings. ? Appendices preparation and publishing as well as regulatory submission. ? Validated and up-to-date case processing platform in a secure environment. ? Scientific Literature Surveillance. ? Infrastructure hosted on cloud and maintained by Cognizant . ? Reconciliation of PV database with clinical database. ? Platform-integrated safety metrics that benchmark and track ? Population Studies & Pharmaco-epidemiology Assessment. PV process performance, efficiency and quality. III. Cognizant 's Pharmacovigilance IT Solutions and Services ? Outcomes/Transactions based flexible pricing. We provide IT services across the entire PV value chain for the top-most pharmaceutical and biotech companies of the ASPIRE LITE - Safety data repository, signal world. With 550-plus associates, the PV IT solutions team detection and reporting framework brings along with it rich experience and expertise in clinical and safety domains.

6 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 ? Proven, technology-independent solution that is now co- ? Integration of medical dictionaries with COTs applications marketed along with SAS. ? Design, development & submission of regulatory, ? Substantial reduction in analysis, design and development operational, analytical & custom reports effort resulting in a cost benefit ranging from 15% to 30%.

7 Pharmacovigilance (PV) CoE 2. APPRAISE - COTS evaluation Discover Understand current state Develop Future Vision of PV at Client site for PV at Client site ? Requirements Generate Business Requirements AHP-based tool to evaluate multiple Gather alternatives based on client-specific Prioritize Requirements business requirements. ? Extensive domain and application Package Evaluation Process knowledge built through experience evaluating CTMS, EDC, AERS, signal Evaluate Evaluate Package Features Evaluate Vendor Evaluate TCO Verify Customer Acceptance detection, patient profile viewer and Package Vendor product complaints handling. Demo/Vendor Vendor Questionnaire Questionnaire Questionnaire Response/ Vendor Reference Response Response Discussions Checks Select Package Evaluation Summary Our Proven Levers for Delivering Operational Excellence in Pharmacovigilance Engagements Proven Cognizant levers for delivering operational excellence in clinical data services engagements Continuous Seamlessly Innovation CARES Quality &.

8 Training Process Integrated Transition Management Business Improvement Metrics Transformation ? CARES Transition s Accuracy of data entry process increased from 97% to 99%. Proven methodology with over 100-plus transitions; by introducing scanning and tracking database options for Connect, Assess, Re-design, Execute and Stabilize (CARES) case assessments and quality review of cases. transition ensures risk free transition from clients to s Accuracy improved for PSUR writing process to 95% for Cognizant . simple to complex reports. ? Seamlessly Integrated Metrics ? Continuous Process Improvement Cognizant ensures that all PV engagements have an Cognizant leverages Six Sigma & lean concepts for continuous integrated metrics measurement and reporting component. process improvements to reduce process variations and These well-defined metrics are standardized and improve process quality and timeliness. This approach benchmarked against operational best practices. The metrics enables us to take preventive measures to avoid re- are captured and accessed in near real-time through an occurrence of defects and ensure high productivity with interface that provides visual insights into the health of the quality deliverables in the steady state of the engagement.

9 Engagement through dashboards, graphs, and charts in s Improved productivity by 18 to 20% for case processing regular status reports. Typical metrics captured include: through automation. s Mean ICSR Turnaround Time (TAT). ? Innovation & Ideation s Pending submissions for a drug. Cognizant is committed to provide business transformation in s Cost per ICSR. all our strategic client relationships leveraging ideation and s Mean time for Medical Review. innovation concepts. Most of the ideas are implemented as Kaizen or Lean projects or DICE (Digital Idea Center) that s Accuracy % in Case Entry. allows the collection, review and implementation of s Missing AEs in a Report. innovation ideas from the operations and management teams. Our PV projects have achieved 100% adherence in ? Training turnaround time for all types of serious adverse event cases. w Customized plans for each engagement focusing on each ? Quality Management role and experience level. The plans are designed to Cognizant develops unique and customized Quality ensure continuous trainings for all skills required for a Management Plan (QMP) for each engagement.

10 The QMP successful engagement. consists of transactional Quality Control (QC) and w Training programs are delivered through class room comprehensive Quality Assurance (QA). The QMP leverages Six sessions lead by expert trainers, e-learning; interactive Sigma & lean methodologies with periodic internal Quality learning mode like memory aids, podcasts, videos etc. Audits to ensure quality and compliance of each engagement. w Certified vendors & partners to deliver specialized training. Pharmacovigilance (PV) CoE 3. PV Expertise Delivered Consistently Oracle - ? Platinum Partner ? Co-development of strategic Oracle projects. ? 1,000+ safety professionals across consulting, IT ? Beta testing of multiple product lines. and KPO. SAS - ? Platinum Consulting Partner. ? PV Center of Excellence to develop and retain ? Substantial investments to build solutions-targeted talent. SAS practices. ? Partnership with Symogen for certification course Extedo - ? Partnership for implementing, maintaining and approved by WHO-UMC, Royal College of Physicians and ISoP.