Accenture Accelerated R&D Services: CDISC Conversion Service Overview

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1 Accenture Life Sciences Rethink Reshape Restructure for better patient outcomes Accenture Accelerated R&D Services: CDISC Conversion Service Overview

2 Using standards to drive speed to market and meet regulatory requirements Lack of standardization in clinical trial data has the potential to impede the review and approval process for new pharmaceutical products. Delays to market are costly up to $1 million per day and strain the capacity of companies regulatory functions. Pressure is mounting from regulatory agencies for pharmaceutical companies to standardize and fast. In the U.S., the reauthorized Prescription Drug User Fee Act (PDUFA) authorizes the FDA to mandate that clinical trial data be submitted in a particular format as early as The selected standard is the Study Data Tabulation Model (SDTM) developed by the non-profit Clinical Data Interchange Standards Consortium (CDISC). Now pharmaceutical companies are racing to convert clinical trial data from multiple formats to a consistent standard, while exploring how to establish data standards to govern future studies. Additionally, interim cuts of data from ongoing studies are also now being converted to SDTM and ADaM to support analysis prior to database lock. Getting a head start on such analysis can save valuable time once the study is closed. 1

3 Our Accelerated CDISC Conversion service delivers significant benefits, including 30 35% reduction in conversion costs, shortening of conversion times by 30 35% and improving data consistency. Industrializing SDTM data conversions Lack of domain expertise hobbles many SDTM conversion efforts. The teams require significant oversight to resolve the complexities of converting multiple competing formats to the SDTM standard. Time ticks away through these questionand-answer cycles, and pharmaceutical sponsors or their vendors may lack the SDTM expertise to provide the necessary direction. In contrast, our professionals are the leading domain experts on the application of CDISC standards. Through our acquisition of Octagon, Accenture has broadened its CDISC capabilities and market presence. We have completed over 925 study conversions across more than 15,000 domains. In addition, we have served as a trainer for the FDA, and we actively participate in CDISC initiatives and co-author CDISC standards. Beyond domain expertise, pharmaceutical companies need on-demand resources with extensive conversion experience, well-tested tools, roadmaps and processes for implementing CDISC standards at a reasonable cost. By converting vast streams of clinical data cost effectively and accurately, Accenture s 24x7 SDTM conversion teams help pharmaceutical companies increase speed to review and meet regulatory requirements. With the conversion burden lifted, these companies are then able to reassign resources to driving standardization up the R&D pipeline. 2

4 Accenture helps clients implement the SDTM data standard by successfully addressing the complex mapping and conversion activities associated with legacy data. Accenture s unique capability and experience Because of the imperative to meet submission targets, the pharmaceutical industry needs dependable and costeffective conversion of clinical data to CDISC standards. To do this in a truly effective and efficient way, Accenture has developed industrialized conversion capabilities that are reliable, repeatable, scalable and accurate. Accenture has blended deep standards experience and well-tested data conversion processes with our global R&D footprint, operational excellence and leading-edge tools and technology (see Figure 1). Unlike providers that just implement conversions and appear to lower costs per converted study, Accenture s proven process delivers high quality outcomes while driving down costs. We understand the intricacies of converting raw data into the SDTM format and have the knowledge to anticipate cause-and-effect relationships, exceptions and nuances that are unique to your environment. Our analytical processes and tools allow us to work independently, efficiently and globally. Our experience and insight allow pharmaceutical companies to accelerate the conversion process, reduce rework, and design technology and processes to be faster and less expensively. We help clients meet both their conversion objectives and their larger business objectives. Figure 1: Why Accenture? Agency Experience Operational Excellence Approach Value Creation Independent and Transparent Model Are CDISC Registered Solution Provider for eight years with experience on 925+ studies and 15,000+ domains Authored/contributed more than 20 CDISC standards/ versions and chaired CDISC committees/boards Trained FDA reviewers in the SDTM model Were awarded FDA contract to convert 100+ studies and consult on domains Have detailed and efficient process for high-quality submission deliverables Bring proprietary tools for confirming traceability from collection through analysis Provide cost-efficient and scalable delivery models specifically for STDM conversions Are current on all regulatory changes Bring forensic insights into your data to inform quick decisions and long-term improvement Have comprehensive SDTM Architect Library Are proficient in building Metadata Libraries Provide standards offering for in-line SDTM collection and long-term governance Provide a turn-key operation Bring an independent team of professionals requiring significantly less sponsor time Offer unit-based pricing models to accommodate demand variances Are committed to client outcomes with complete transparency Outcomes Focused: Time: 30-35% reduction in conversion timelines Cost: 30-35% reduction in conversion costs Quality: Predictable agency-proven deliverables 3

5 Getting started: reliable, repeatable SDTM conversions There are three ways to get started using our CDISC Conversion service. We can run a pilot with one or two studies destined for submission, or we can validate an existing study in SDTM format. The third option is a clinical data asset review. Pilot: The Accenture conversion team produces SDTM-compliant datasets for submission in less than seven weeks. Through the pilot, we demonstrate the quality and efficiency of our SDTM conversion teams. Validation: Accenture domain experts examine whether converted datasets are SDTM compliant and therefore likely to gain regulatory acceptance of the data. To do that, they assess the compliance of the SDTM domains as well as the completeness and relevance of the SDTM implementation. Recommendations for remediation, if necessary, are typically provided within one to two weeks. Clinical data asset review: Accenture reviews all the studies within the program destined for submission. In one to two weeks, we can typically assess the submission readiness of all the data and associated documentation. Use of CDISC standards, refined and developed as needed, will result in highquality submissions that will be reviewed more quickly. The likelihood of an approval on the first review cycle will increase. 1 4

6 Accenture can provide the full package decades of management consulting, stellar BPO execution, and all the technology and analytics required to drive successful R&D outcomes. Driving standardization up the R&D pipeline For many pharmaceutical companies, the immediate time-critical need is the conversion of data from hundreds of clinical studies to the SDTM standard. Our conversion service fulfills that purpose. It is highly inefficient to collect data in nonstandardized formats and then fix it. Unless global standards, metadata and governance are implemented at the beginning of clinical studies, companies will continue to reinvent the wheel and convert data inefficiently at the end of the process. Pharmaceutical companies recognize the importance of collecting data in submission-ready formats. They are eager to gather data in real time in the right way. Through our Standards Definition and Management service, Accenture is ready to help pharmaceutical companies on that journey, with the goal of driving standardization up the R&D pipeline. We bring a deep domain point of view to data standardization initiatives of any scale, whether a company is improving existing standards or starting from scratch. Our expert consultants have the domain experience required to help pharmaceutical companies set up governance organizations and the necessary supporting mechanisms, stay up to date on evolving standards, and use the tools we offer to manage the defined metadata. As pharmaceutical companies move through the stages of CDISC standards maturity, they will achieve both regulatory compliance and process efficiencies (see Figure 2). Figure 2: CDISC Maturity Model Lagging Compliant Basic Compliant + Emerging Efficient Leading Integrated Description Convert late-stage for point submission needs (often legacy) Standards STDM ADaM STDM Metadata Management Low or None Convert mid-process for analysis in SDTM and submission Moderate (Usually with Excel) Capture CDISC-compliant data for process efficiency and submission needs CDASH ADaM SDTM High Metadata Repository Design protocol/forms using standards for process efficiency and submission benefits PRM SEND CDASH ADaM SDTM Full Featured Metadata Registry Governance Low Moderate High Cross-Functional and MDR-supported Sponsor Benefits Data traceability and other regulatory compliance Process efficiency for time/cost savings 5

7 Accenture s conversion service to CDISC standards helps pharmaceutical companies: Cut costs Our scalable, unit-based pricing helps match supply and demand for data conversion efforts. Rework is minimized, manual maintenance tasks reduced and miscommunications prevented. When implemented at the beginning of the clinical trial process, aligning to CDISC standards has been shown to cut resource requirements by 60% overall and by 70-90% in the start-up stages of trials. 2 Decrease cycle times Implementation to standards has decreased cycle times, in some cases by as much as eight months. Agency rejections for submission-ready compliance have dropped from 50% (nearly all clinical) to 5%. Reduce rework Our proprietary tools can be used to monitor and facilitate resolution of issues associated with submission component readiness. Timely access to this information allows companies to determine how much time is spent reprocessing components. Submission quality rises while rework drops. Streamline queries Higher-quality submissions can both help preempt questions and accelerate answering questions. Without standardization, as one study reported, 70-80% of the cost and effort of answering regulatory or safety queries is spent finding, retrieving and shaping data to address questions. 3 FDA SDTM/ADaM conversion project The U.S. Food and Drug Administration (FDA) was unable to assess clinical data for safety and efficacy across multiple providers in a timely manner. The solution was to convert the data from hundreds of studies into submission-ready format using two CDISC standards SDTM and ADaM (Analysis Dataset Models), which enables statistical analysis. Why Accenture? We are the industry leader in conversions to CDISC standards, with a mature process approach and intimate knowledge of both CDISC concepts and applications. We have a multi-level relationship with the agency as a service provider, a collaborator in the evolution of standards and a reviewer of training on CDISC standards. This multiyear project started in 2010 and continues today. The repeatable, scalable processes implemented for this project allow the agency to reach its goal of performing comparative effectiveness analysis within specified timeframes. At the same time, Accenture provides insight and expertise in the creation of new guidance and domains for CDISC standards. Standardizing to CDISC data models facilitates the flow of data across the functional areas of pharmaceutical R&D and, therefore, helps bring to fruition the broader vision of Accelerated R&D. Sources 1. CDISC Consortium website: d3c7e8b6690f991da920e7e60dee0568/misc/fda_cdiscmeeting1feb10summarybodfin.pdf 2. Cindy Carpenter, Accenture acquires Octagon Research Soutions as competition heats up in pharma, HfS Research, September Frank Rockhold and Simon Bishop, Extracting the value of standards: The role of CDISC in a pharmaceutical research strategy, Clin Eval 40(1):

8 Contact us to learn more To learn more about how Accenture is helping companies, please visit accenture.com/lifesciences or contact one of our managing directors: David Boath Dave Evans About Accenture Life Sciences Accenture s Life Sciences practice is dedicated to helping companies rethink, reshape or restructure their businesses to deliver better health outcomes and drive shareholder returns. We provide consulting, outsourcing and technology around the globe in all strategic and functional areas with a strong focus on R&D, Sales & Marketing and the Supply Chain. We have a long history of working hand in hand with our clients to improve their performance across the entire Life Sciences value chain. Accenture s Life Sciences practice connects more than 10,000 skilled professionals in over 50 countries who are personally committed to helping our clients achieve their business objectives and deliver better health outcomes for people around the world. Stay Connected accenturemanagementconsulting company/accenture Accenture Life Sciences Blog Accenture experts share insights and opinions on opportunities and challenges in the pharmaceutical and medical technology industry. About Accenture Accenture is a global management consulting, technology services and outsourcing company, with approximately 259,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$27.9 billion for the fiscal year ended August 31, Its home page is Copyright 2013 Accenture All rights reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture.