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How we help our customers A leading US pharmaceutical company was challenged by multiple source systems across its lines of business. This resulted in decreased R&D productivity, information being stored in silos, as well as threats to data security of critical intellectual property. Regulatory compliance was also a significant challenge. TCS Drug Development Insights Platform To overcome these challenges, they partnered with TCS. We provided a centralized platform and helped them achieve a consistent view of clinical operational metrics derived from a variety of sources. Our Drug Development Insight platform helped the pharmaceutical company shift its focus from managing IT operations to core business services, with a reduction in cost and oversights. Our platform provided a flexible data and analytical model to derive insight from data for a variety of use cases. It also helped the company onboard over 20 studies for risk based monitoring within 15 months of going live. This included ongoing studies of over 3000 patients. About TCS' Life Sciences Business Unit Life Sciences With over two decades of experience in the life sciences domain, TCS offers a comprehensive portfolio in IT, Consulting, KPO, Infrastructure and Engineering services as well as new-age business solutions including mobility and big data catering to companies in the pharma, biotech, medical devices, and diagnostics industries. Our offerings help clients accelerate drug discovery, advance clinical trial efficiencies, accentuate manufacturing productivity, and amplify sales and marketing effectiveness. We draw on our experience of having worked with 12 of the top 15 global pharmaceutical companies and 8 of the top 10 medical device manufacturers. Our commitment towards developing nextgeneration innovative solutions and facilitating cutting-edge research - through our Life Sciences Innovation Lab, research collaborations, multiple centers of excellence and Co-Innovation Network (COINTM ) - have made us a preferred partner for the world's leading life sciences companies. Contact For more information about TCS’ Life Sciences Business Unit, visit: http://www.tcs.com/industries/life-sciences/Pages/default.aspx Email: [email protected] About Tata Consultancy Services Ltd (TCS) Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT and IT-enabled, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery ModelTM, recognized as the benchmark of excellence in software development. A part of the Tata Group, India’s largest industrial conglomerate, TCS has a global footprint and is listed on the National Stock Exchange and Bombay Stock Exchange in India. All content / information present here is the exclusive property of Tata Consultancy Services Limited (TCS). The content / information contained here is correct at the time of publishing. No material from here may be copied, modified, reproduced, republished, uploaded, transmitted, posted or distributed in any form without prior written permission from TCS. Unauthorized use of the content / information appearing here may violate copyright, trademark and other applicable laws, and could result in criminal or civil penalties. Copyright © 2015 Tata Consultancy Services Limited TCS Design Services I M I 12 I 15 For more information, visit us at www.tcs.com Changing regulatory standards and growing service delivery expectations are driving pharmaceutical companies to adopt advanced data management strategies. Data standardization and collection, and enhanced reporting controls are now vital to gain an integrated view of data trends. However, information silos emerge in these organizations as they look to leverage next-generation technology tools for increased responsiveness. The demands from digitally-aware patients, medical investigators, and other relevant stakeholders for real-time information updates have also increased. Therefore, relevant data insights during clinical trials can offer a proactive approach to drug development and help in timely risk monitoring. Relevant sources Platform capability Features 1. Search and explore BPM Enterprise search Portal and collaboration Business processes 2a. Site selection 2b. Patient recruitment and adherence 2c. Study performance management 2d. Risk-based monitoring 2e. Study finance 2f. Clinical trial supplies Information exchange platform Internal and external structured data sources Tata Consultancy Services' (TCS') Drug Development Insights Platform offers the capability to aggregate clinical data from a range of structured and unstructured data repositories. This information is standardized, integrated, and fed into a centralized clinical data repository to check for regulations compliance, and to conduct cross-study analytics, and value-evidence programs. Platform Analytics Other analytics 1b. Safety 2a to 2f Clinical ops metrics Supply mgt. Health outcome and health evidence Study design team Safety Regulatory MDM Medical devices and wearable biosensors 1a. Clinical 1c. Regulatory 2. Analyze External, unstructured data sources Insights 3. Share and distribute Content management 3.1 Data standardization 3.2 Data anonymization Security Disclosure 3.3 Document redaction An Overview of TCS Drug Development Insights Platform Overview Our Solution Benefits The TCS Advantage To accelerate performance in a competitive market, pharmaceutical organizations require access to timely and relevant clinical data. The absence of real-time information and insights makes it difficult to monitor the number of patient dropouts or understand whether the trial is compliant with evolving regulations. It is also increasingly challenging to conduct course-corrections during the clinical trial process. This in turn increases rework and iterations across the development cycle and causes delays that negatively impact the decision-making process. With the inability to integrate data streams from myriad devices, patient diaries, and electronic Clinical Outcome Assessment (eCOA) solutions, pharmaceutical organizations may overlook businessenhancing insights. Challenges emerging from manual clinical development processes have highlighted the need for a scalable technology platform that can address emerging issues. TCS' platform aggregates, ingests and analyzes clinical data from operational systems and provides risk-based monitoring, site selection analytics, patient recruitment and retention analytics, and study performance analytics. We provide: TCS' Drug Development Insights Platform helps enterprises reimagine their existing clinical data processes and enables the pharmaceutical industry to achieve their business objective of bringing medicines faster to patients. The solution accelerates and improves clinical data management and analytics, while a metadata-driven approach addresses non-standardized data and exceptions in data range and type. This enables robust data validation and quality assurance, while reducing overall programming and on-boarding efforts. By adopting the offering, enterprises can: Our platform helps enterprises gain both business agility and deliver innovative products and services. We deliver tangible results through: TCS' Drug Development Insights Platform offers a single centralized data repository that caters to users throughout clinical operations and post-authorization processes, involving biostatisticians, medical writers, and regulatory teams. The study data can also be leveraged across several functions such as Clinical Data Management, Research and Development (R&D), Medical Affairs, and non-interventional studies, enabling detailed and faster responses to regulatory authorities. TCS' clinical data warehouse is based on industry-specific standards such as Study Data Tabulation Model (SDTM) and Biomedical Research Integrated Domain Group (BRIDG), and can be easily connected to a host of source systems. n Configurable workflows: Our platform covers comprehensive risk assessment and categorization, centralized monitoring and issue management processes n Integrated data browser: This enables the search and exploration of data across its lifecycle and the flexibility to plug in a variety of visualization tools to view information from the clinical data warehouse n Ensure rapid study setup and execution by leveraging metadata capabilities in all stages of clinical development. n Service-based model: The platform provides insights through a Business Process as a Service (BPaaS) model pertaining to clinical data management, risk-based monitoring, biostatistics and clinical operations n Address scientific and operational analytical needs across units by establishing an accessible, comprehensive and definitive data source, and by implementing a robust data-tracking mechanism across key processes and systems n Unified data processing: The metadata-driven approach allows data from local and central labs, CROs, patient diaries, EDC systems, medical devices and other data sources to be integrated and validated seamlessly n Effectively utilize resources and minimize human intervention in data management and operational processes, by automating and streamlining the flow of clinical information n Reuse and reduce hand-offs by driving collaboration across units, building a comprehensive knowledge repository, and through established standards n Ensure prompt action on regulatory queries by generating submission-ready outputs n Drive informed decisions by leveraging actionable business insights from clinical data, to ensure product quality and meet regulatory requirements n A flexible and scalable approach: TCS provides information on demand through our significant expertise in delivering accurate, ‘analytics-ready’ data. Our comprehensive set of out-of-box, ready-touse features drives data integration, aggregation and analytics n Reinforced data protection: Our validated and externally-hosted solution incorporates stringent security measures, and is up-to-date with the changing compliance and regulatory requirements of the pharmaceutical industry n Domain experience and relevant technology expertise: TCS’ combines its extensive capabilities as a clinical research services provider, platform solution provider and global systems integrator to deliver strategic solutions fulfilling various customer requirements n Analyst recognition: TCS was designated as a Leader in Worldwide Life Sciences R&D Risk-Based Monitoring by global market intelligence firm, IDC, in the “IDC MarketScape: Worldwide Life Science R&D Risk-Based Monitoring 2015 Vendor Assessment,” (April 2015) report. TCS was recognized as a leader for its overall capability and extensive experience working with life science companies across all three sections of the industry: pharmaceutical, biotech and medical devices. Changing regulatory standards and growing service delivery expectations are driving pharmaceutical companies to adopt advanced data management strategies. Data standardization and collection, and enhanced reporting controls are now vital to gain an integrated view of data trends. However, information silos emerge in these organizations as they look to leverage next-generation technology tools for increased responsiveness. The demands from digitally-aware patients, medical investigators, and other relevant stakeholders for real-time information updates have also increased. Therefore, relevant data insights during clinical trials can offer a proactive approach to drug development and help in timely risk monitoring. Relevant sources Platform capability Features 1. Search and explore BPM Enterprise search Portal and collaboration Business processes 2a. Site selection 2b. Patient recruitment and adherence 2c. Study performance management 2d. Risk-based monitoring 2e. Study finance 2f. Clinical trial supplies Information exchange platform Internal and external structured data sources Tata Consultancy Services' (TCS') Drug Development Insights Platform offers the capability to aggregate clinical data from a range of structured and unstructured data repositories. This information is standardized, integrated, and fed into a centralized clinical data repository to check for regulations compliance, and to conduct cross-study analytics, and value-evidence programs. Platform Analytics Other analytics 1b. Safety 2a to 2f Clinical ops metrics Supply mgt. Health outcome and health evidence Study design team Safety Regulatory MDM Medical devices and wearable biosensors 1a. Clinical 1c. Regulatory 2. Analyze External, unstructured data sources Insights 3. Share and distribute Content management 3.1 Data standardization 3.2 Data anonymization Security Disclosure 3.3 Document redaction An Overview of TCS Drug Development Insights Platform Overview Our Solution Benefits The TCS Advantage To accelerate performance in a competitive market, pharmaceutical organizations require access to timely and relevant clinical data. The absence of real-time information and insights makes it difficult to monitor the number of patient dropouts or understand whether the trial is compliant with evolving regulations. It is also increasingly challenging to conduct course-corrections during the clinical trial process. This in turn increases rework and iterations across the development cycle and causes delays that negatively impact the decision-making process. With the inability to integrate data streams from myriad devices, patient diaries, and electronic Clinical Outcome Assessment (eCOA) solutions, pharmaceutical organizations may overlook businessenhancing insights. Challenges emerging from manual clinical development processes have highlighted the need for a scalable technology platform that can address emerging issues. TCS' platform aggregates, ingests and analyzes clinical data from operational systems and provides risk-based monitoring, site selection analytics, patient recruitment and retention analytics, and study performance analytics. We provide: TCS' Drug Development Insights Platform helps enterprises reimagine their existing clinical data processes and enables the pharmaceutical industry to achieve their business objective of bringing medicines faster to patients. The solution accelerates and improves clinical data management and analytics, while a metadata-driven approach addresses non-standardized data and exceptions in data range and type. This enables robust data validation and quality assurance, while reducing overall programming and on-boarding efforts. By adopting the offering, enterprises can: Our platform helps enterprises gain both business agility and deliver innovative products and services. We deliver tangible results through: TCS' Drug Development Insights Platform offers a single centralized data repository that caters to users throughout clinical operations and post-authorization processes, involving biostatisticians, medical writers, and regulatory teams. The study data can also be leveraged across several functions such as Clinical Data Management, Research and Development (R&D), Medical Affairs, and non-interventional studies, enabling detailed and faster responses to regulatory authorities. TCS' clinical data warehouse is based on industry-specific standards such as Study Data Tabulation Model (SDTM) and Biomedical Research Integrated Domain Group (BRIDG), and can be easily connected to a host of source systems. n Configurable workflows: Our platform covers comprehensive risk assessment and categorization, centralized monitoring and issue management processes n Integrated data browser: This enables the search and exploration of data across its lifecycle and the flexibility to plug in a variety of visualization tools to view information from the clinical data warehouse n Ensure rapid study setup and execution by leveraging metadata capabilities in all stages of clinical development. n Service-based model: The platform provides insights through a Business Process as a Service (BPaaS) model pertaining to clinical data management, risk-based monitoring, biostatistics and clinical operations n Address scientific and operational analytical needs across units by establishing an accessible, comprehensive and definitive data source, and by implementing a robust data-tracking mechanism across key processes and systems n Unified data processing: The metadata-driven approach allows data from local and central labs, CROs, patient diaries, EDC systems, medical devices and other data sources to be integrated and validated seamlessly n Effectively utilize resources and minimize human intervention in data management and operational processes, by automating and streamlining the flow of clinical information n Reuse and reduce hand-offs by driving collaboration across units, building a comprehensive knowledge repository, and through established standards n Ensure prompt action on regulatory queries by generating submission-ready outputs n Drive informed decisions by leveraging actionable business insights from clinical data, to ensure product quality and meet regulatory requirements n A flexible and scalable approach: TCS provides information on demand through our significant expertise in delivering accurate, ‘analytics-ready’ data. Our comprehensive set of out-of-box, ready-touse features drives data integration, aggregation and analytics n Reinforced data protection: Our validated and externally-hosted solution incorporates stringent security measures, and is up-to-date with the changing compliance and regulatory requirements of the pharmaceutical industry n Domain experience and relevant technology expertise: TCS’ combines its extensive capabilities as a clinical research services provider, platform solution provider and global systems integrator to deliver strategic solutions fulfilling various customer requirements n Analyst recognition: TCS was designated as a Leader in Worldwide Life Sciences R&D Risk-Based Monitoring by global market intelligence firm, IDC, in the “IDC MarketScape: Worldwide Life Science R&D Risk-Based Monitoring 2015 Vendor Assessment,” (April 2015) report. TCS was recognized as a leader for its overall capability and extensive experience working with life science companies across all three sections of the industry: pharmaceutical, biotech and medical devices. How we help our customers A leading US pharmaceutical company was challenged by multiple source systems across its lines of business. This resulted in decreased R&D productivity, information being stored in silos, as well as threats to data security of critical intellectual property. Regulatory compliance was also a significant challenge. TCS Drug Development Insights Platform To overcome these challenges, they partnered with TCS. We provided a centralized platform and helped them achieve a consistent view of clinical operational metrics derived from a variety of sources. Our Drug Development Insight platform helped the pharmaceutical company shift its focus from managing IT operations to core business services, with a reduction in cost and oversights. Our platform provided a flexible data and analytical model to derive insight from data for a variety of use cases. It also helped the company onboard over 20 studies for risk based monitoring within 15 months of going live. This included ongoing studies of over 3000 patients. About TCS' Life Sciences Business Unit Life Sciences With over two decades of experience in the life sciences domain, TCS offers a comprehensive portfolio in IT, Consulting, KPO, Infrastructure and Engineering services as well as new-age business solutions including mobility and big data catering to companies in the pharma, biotech, medical devices, and diagnostics industries. Our offerings help clients accelerate drug discovery, advance clinical trial efficiencies, accentuate manufacturing productivity, and amplify sales and marketing effectiveness. We draw on our experience of having worked with 12 of the top 15 global pharmaceutical companies and 8 of the top 10 medical device manufacturers. Our commitment towards developing nextgeneration innovative solutions and facilitating cutting-edge research - through our Life Sciences Innovation Lab, research collaborations, multiple centers of excellence and Co-Innovation Network (COINTM ) - have made us a preferred partner for the world's leading life sciences companies. Contact For more information about TCS’ Life Sciences Business Unit, visit: http://www.tcs.com/industries/life-sciences/Pages/default.aspx Email: [email protected] About Tata Consultancy Services Ltd (TCS) Tata Consultancy Services is an IT services, consulting and business solutions organization that delivers real results to global business, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT and IT-enabled, infrastructure, engineering and assurance services. This is delivered through its unique Global Network Delivery ModelTM, recognized as the benchmark of excellence in software development. A part of the Tata Group, India’s largest industrial conglomerate, TCS has a global footprint and is listed on the National Stock Exchange and Bombay Stock Exchange in India. All content / information present here is the exclusive property of Tata Consultancy Services Limited (TCS). The content / information contained here is correct at the time of publishing. No material from here may be copied, modified, reproduced, republished, uploaded, transmitted, posted or distributed in any form without prior written permission from TCS. Unauthorized use of the content / information appearing here may violate copyright, trademark and other applicable laws, and could result in criminal or civil penalties. Copyright © 2015 Tata Consultancy Services Limited TCS Design Services I M I 12 I 15 For more information, visit us at www.tcs.com