Did you know? Accenture can deliver business outcome-focused results for your life sciences research & development organization like these:

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1 How can Accenture Accelerated R&D BPO Services help you achieve greater business value? Did you know? Accenture can deliver business outcome-focused results for your life sciences research & development organization like these: Reduce cycle times by in productivity 45% 30% increase 30% reduced costs with 3-5% year-over-year savings > 99.9% accuracy in pharmacovigilance field-level quality SEE HOW WE DELIVER We understand what life sciences organizations need and the challenges they are facing. Life sciences companies are facing patent cliffs, increased competition in the generics market, and the cost, time, and regulatory pressure of bringing a new drug to market. We help our clients: Reduce the timeline to bring new products to market Improve regulatory compliance Optimize R&D operating costs

2 Delivering business value through BPO Accenture Accelerated R&D BPO provides services that enable faster drug development, proactive pharmacovigilance, harmonized processes and tools, and reduced overall research & development costs. Robust database and analytics drive high-performing investigator selection, better decision making and improved clinical, regulatory and safety outcomes. Deep industry skills with more than 3,000 professionals who work in Life Sciences Research and Development (R&D) globally. Understanding of global health authority regulations and submission requirements and strategic partnerships with leading regulators including the U.S. Food Drug Administration (FDA). Market leader in the regulatory and clinical data services domain using an industry leading suite of proprietary and third-party software. Combined capabilities across integrated consulting, technology and outsourcing for data-driven clinical trial strategy and design, and global delivery solutions, enabled by industry-leading technologies. BPO Navigator Tool offers real-time access to key business data to facilitate insightful collaboration between our client executives and delivery teams.

3 Accenture Accelerated R&D BPO is different 20 years experience in pharmacovigilance and regulatory systems, processes and organizations 4 delivery locations: Mumbai, Bangalore, Chennai, Dalian More than 1,400 BPO Research & Development resources in our delivery centers, 2 of the 6 original Clinical Data Interchange Standards Consortium (CDISC) and Study Data Tabulation Model (SDTM) authors Clients include all 10 of the top 10 pharmaceutical companies Accelerated R&D BPO services provided in English & Japanese Onshore services staff in US, UK, Japan and Belgium Strategic relationship with leading regulators including the U.S. Food and Drug Administration (FDA) 74 submissions to the U.S. Food and Drug Administration (FDA) using Study Data Tabulation Model (SDTM) For 6 consecutive years, Accenture has been ranked the top ITO/BPO provider IAOP Global Outsourcing 100

4 Key Accenture Accelerated R&D BPO Services Clinical Data Management Clinical Study Set-up Data Editing & Cleaning Statistical Programming Medical & Drug Coding Medical Writing Clinical Data Interchange Standards Consortium (CDISC) Regulatory Services & Solutions Global Submission Dossier Management Global Product Lifecycle Management Label Lifecycle Management Document Publishing Pharmacovigilance Safety Case Management Medical Review Report Writing & Distribution to Health Authorities Aggregate Reporting Literature Searching

5 Client Speak How Accenture Helped a Global Pharmaceutical Company How Accenture Helped a European Pharmaceutical Company How Accenture Helped the U.S. Food and Drug Administration (FDA) Created an integrated study design service unit comprising onshore and offshore experienced staff. The unit sets up data collection and tools for clinical trials and also handles related activities such as training, project management, standard operating procedures and performance management. Decreased study design and development costs by 45 percent, and reduced cycle time by 30 percent. Improved report quality by 30 percent. 100 percent compliant with electronic data capture standards and with Clinical Data Interchange Standards Consortium requirements (CDISC). Reduced number of quality control and user acceptance testing rounds from four to six, to just two. Transferred the client s Central Drug Safety function to an Accenture team of 90 drug safety professionals in India. Completed transition of the offshore team in just over 12 months with live production in less than 100 days from contracting. Established technology, unit operations and service management processes during transition while maintaining full coverage of European and US time zones by using a two-shift model. Developed a unique case processing model that can sustain and function under the inherent uncertainties of incoming volumes and can adapt to changing regulatory requirements. Worked with CDISC, ScenPro and the U.S. FDA (through our acquisition of Octagon) to support the U.S. FDA s large-scale complex project of converting legacy study data to an electronic standard format(s). Developed a multi- disciplinary relationship with the U.S. FDA. Acted as a service provider, Clinical Data Interchange Standards Consortium (CDISC) thought partner, trainer for reviewers for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards, and assessors of emerging domains in "real time." Awarded five-year contract in 2010 to convert 300+ studies to SDTM and ADaM. Included the SDTM conversion and creation of ADaM datasets for ~100 studies in the initial scope. Provided insight and skills in creation of new standards of domains for CDISC Accenture. All Rights Reserved.

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