ADD Data Standardization and Biometrics Digital Advangage for Life Sciences
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ADD Data Standardization and Biometrics
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 © 2021 Tata Consultancy Services Limited
IT ServicesBusiness SolutionsConsulting
To know more Visit the
https://www.tcs.com/advanced-drug-development page on tcs.com
Email: [email protected]
Awards & Recognition
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.
For more information, visit us at www.tcs.com
Cor
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Mar
ketin
g | D
esig
n Se
rvic
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M |
02 |
21
Digital Advangage for Life Sciences
2019
WINNER
CLINICALRESEARCHNEWS
“ADD Data Standardization & Biometrics offers us an opportunity to revolutionize our clinical development by automating the process of converting study data to submission-ready SDTM data.”Head, clinical data standard, top-20 pharmaceutical company
About TCS ADD Platform
TCS ADD is a modern and open drug development platform for life sciences that enables digital
ecosystems, simplifies data complexity and provides faster access to new and effective drugs for
patients in need. The platform is powered by our proprietary cognitive artificial intelligence
engine, data driven smart analytics and Internet of Things (IoT) that makes clinical trials more
agile and safe. TCS ADD leverages the best of cloud architecture and personalized user
experience design in compliance with quality guidelines and privacy regulations.
Life science industries routinely face inconsistencies and challenges in managing diverse data standards
and output templates, leading to process inefficiencies. Across the entire study build process — protocol,
data collection, and submission — life science industries have to deal with non-standard data. In
addition, manual programming and disjointed downstream processing adds to the process time for
study data tabulation models (SDTM). The aim, thus, is to build an automated and integrated,
metadata-driven, end-to-end process, leveraging standards as the driving force.
ADD Data Standardization and Biometrics solution streamlines data from collection to submission.
Metadata harmonization provides automated study build and transformation into submission-ready
formats, enabling faster study set-up, increased quality and compliance. Our solution offers data
integration and standardization that help enterprises perform on-demand data operations.
In addition, the macro-based solution includes a comprehensive library of derivations and
validations compliant with regulations like CDISC. The solution leverages intuitive mappings
and real-time data availability, enabling early SDTM.
Overview
The challenges for life science industries start at the study level, with limited business and scientific content management across different products and therapeutic areas. The companies seek an automated, integrated and controlled environment for biometrics and biostatistical computing analysis. The current process limits integration and usage of data from diverse sources, and historical and legacy data, leading to reduced statistical power and reliability. Further, the absence of a governance model for handling and maintaining ever-evolving standards and multiple versions hampers cross-departmental data lineage and oversight. Converting data to a submission-ready format is yet another challenge with disjointed downstream processing increasing SDTM processing time.
ADD Data Standardization and Biometrics solution provides a next-gen solution to manage clinical standards for industry and sponsors. It automates the entire study build process while consistently governing data throughout the cycle. The solution comprises a clinical study design workbench with automated data transfer agreements, automated study build capabilities, and the ability to generate submission-ready SDTM data and packages. Our solution offers a controlled environment for biometrics and provisions-integrated metadata management for clinical and non-clinical source of data. This facilitates real-time availability of data for downstream processing.
Solution The TCS Advantage
ADD Data Standardization and Biometrics comes
with these unique advantages:
Agile approach: Readymade data integration and standardization helps users perform data operations on demand. Our solution allows quick and hassle-free onboarding of CDISC-compliant SDTM and NCI-controlled terminology metadata.
Focus on reusability: Our solution offers an exhaustive library of derivations and validations conforming to CDISC regulations. Data can be auto-mapped to ongoing or concluded clinical studies, and users can create copies of data or metadata from existing projects and the global library. Transmission mapping can be reused and auto-mapped based on study metadata.
Scalability: Our solution can be scaled to any level based on the business need.
Modular platform: The components of our highly modular solution can be implemented separately or in combination, depending on the business need.
Flexible: The platform can be implemented as a standalone solution or on top of existing solutions.
Technology and domain expertise: TCS-certified subject matter experts combine our extensive capabilities as clinical research services provider, platform solution provider and global systems integrator to deliver strategic solutions.
Analyst recognition: Our ADD solutions have been consistently recognized by leading analysts, such as Everest Group PEAKTM Matrix, IDC MarketScape, HFS Research and 451 Research, as a key enabler for life science organizations' commercial off-the-shelf digital solutions.
Benefits
ADD Data Standardization and Biometrics offers the
following benefits:
Automation: Automates EDC study build, data generation and transformation to submission-ready SDTM datasets and unique SAS code.
Reduced workload: Reduces EDC study build efforts by up to 30%, SDTM efforts by up to 70%.
Standard library: Provides a clinical standard library with smart governance, simplifying cross-departmental data lineage and oversight.
Integrated management: Integrates metadata management for clinical and non-clinical data sources.
Increased efficiency: Increases efficiency and productivity with AI and automated analytics at each step and process.
Business agility: Drives business agility by allowing maximum reuse of critical data and various industry-level standards.
Improved data quality: Eliminates data inconsistencies across R&D and clinical trial processes.
Accelerated compliance: Increased compliance with regulatory standards due to automation
Faster drug registration: Reduces Last Subject Last Visit to DataBase Lock (DBL) timelines, leading to early product market submission.
ADD Data Standardization and Biometrics comes with the following key components:
Clinical standards registry and smart governance: Offers a repository of multiple templates and standards, enabling cross-study and product reusability. Enterprises can leverage its workflow and smart governance capabilities to handle evolving standards with ease.
Automated study build: Automates electronic data capture (EDC) study design from standards and templates, interconnecting processes across the entire product cycle.
Integrated metrics and oversight: Offers intuitive metrics to assess usability of standards, allowing consistent governance across the cycle.
Automated SDTM and statistical computing: Automates creation of ready-to-use submission packages using artificial intelligence (AI), providing a controlled environment for biometrics.
INPUT ADD DATA STANDARDIZATION & BIOMETRICS
OUTPUT
Internal(e.g. sponsor
standard library, study design)
Clinical standards registry
Automated study build
Integrated metrics & oversight
Statistical Computing &Auto SDTM
Enterprise data &standard governance
EDC Study Set-up
Submission-ready
SDTM Data & Package
Standards/studycompliance metrics
External data(e.g. public standards)
Structured
Unstructured
ADD Data Standardization and Biometrics: Schematic Overview
Single Source of Truth
Life science industries routinely face inconsistencies and challenges in managing diverse data standards
and output templates, leading to process inefficiencies. Across the entire study build process — protocol,
data collection, and submission — life science industries have to deal with non-standard data. In
addition, manual programming and disjointed downstream processing adds to the process time for
study data tabulation models (SDTM). The aim, thus, is to build an automated and integrated,
metadata-driven, end-to-end process, leveraging standards as the driving force.
ADD Data Standardization and Biometrics solution streamlines data from collection to submission.
Metadata harmonization provides automated study build and transformation into submission-ready
formats, enabling faster study set-up, increased quality and compliance. Our solution offers data
integration and standardization that help enterprises perform on-demand data operations.
In addition, the macro-based solution includes a comprehensive library of derivations and
validations compliant with regulations like CDISC. The solution leverages intuitive mappings
and real-time data availability, enabling early SDTM.
Overview
The challenges for life science industries start at the study level, with limited business and scientific content management across different products and therapeutic areas. The companies seek an automated, integrated and controlled environment for biometrics and biostatistical computing analysis. The current process limits integration and usage of data from diverse sources, and historical and legacy data, leading to reduced statistical power and reliability. Further, the absence of a governance model for handling and maintaining ever-evolving standards and multiple versions hampers cross-departmental data lineage and oversight. Converting data to a submission-ready format is yet another challenge with disjointed downstream processing increasing SDTM processing time.
ADD Data Standardization and Biometrics solution provides a next-gen solution to manage clinical standards for industry and sponsors. It automates the entire study build process while consistently governing data throughout the cycle. The solution comprises a clinical study design workbench with automated data transfer agreements, automated study build capabilities, and the ability to generate submission-ready SDTM data and packages. Our solution offers a controlled environment for biometrics and provisions-integrated metadata management for clinical and non-clinical source of data. This facilitates real-time availability of data for downstream processing.
Solution The TCS Advantage
ADD Data Standardization and Biometrics comes
with these unique advantages:
Agile approach: Readymade data integration and standardization helps users perform data operations on demand. Our solution allows quick and hassle-free onboarding of CDISC-compliant SDTM and NCI-controlled terminology metadata.
Focus on reusability: Our solution offers an exhaustive library of derivations and validations conforming to CDISC regulations. Data can be auto-mapped to ongoing or concluded clinical studies, and users can create copies of data or metadata from existing projects and the global library. Transmission mapping can be reused and auto-mapped based on study metadata.
Scalability: Our solution can be scaled to any level based on the business need.
Modular platform: The components of our highly modular solution can be implemented separately or in combination, depending on the business need.
Flexible: The platform can be implemented as a standalone solution or on top of existing solutions.
Technology and domain expertise: TCS-certified subject matter experts combine our extensive capabilities as clinical research services provider, platform solution provider and global systems integrator to deliver strategic solutions.
Analyst recognition: Our ADD solutions have been consistently recognized by leading analysts, such as Everest Group PEAKTM Matrix, IDC MarketScape, HFS Research and 451 Research, as a key enabler for life science organizations' commercial off-the-shelf digital solutions.
Benefits
ADD Data Standardization and Biometrics offers the
following benefits:
Automation: Automates EDC study build, data generation and transformation to submission-ready SDTM datasets and unique SAS code.
Reduced workload: Reduces EDC study build efforts by up to 30%, SDTM efforts by up to 70%.
Standard library: Provides a clinical standard library with smart governance, simplifying cross-departmental data lineage and oversight.
Integrated management: Integrates metadata management for clinical and non-clinical data sources.
Increased efficiency: Increases efficiency and productivity with AI and automated analytics at each step and process.
Business agility: Drives business agility by allowing maximum reuse of critical data and various industry-level standards.
Improved data quality: Eliminates data inconsistencies across R&D and clinical trial processes.
Accelerated compliance: Increased compliance with regulatory standards due to automation
Faster drug registration: Reduces Last Subject Last Visit to DataBase Lock (DBL) timelines, leading to early product market submission.
ADD Data Standardization and Biometrics comes with the following key components:
Clinical standards registry and smart governance: Offers a repository of multiple templates and standards, enabling cross-study and product reusability. Enterprises can leverage its workflow and smart governance capabilities to handle evolving standards with ease.
Automated study build: Automates electronic data capture (EDC) study design from standards and templates, interconnecting processes across the entire product cycle.
Integrated metrics and oversight: Offers intuitive metrics to assess usability of standards, allowing consistent governance across the cycle.
Automated SDTM and statistical computing: Automates creation of ready-to-use submission packages using artificial intelligence (AI), providing a controlled environment for biometrics.
INPUT ADD DATA STANDARDIZATION & BIOMETRICS
OUTPUT
Internal(e.g. sponsor
standard library, study design)
Clinical standards registry
Automated study build
Integrated metrics & oversight
Statistical Computing &Auto SDTM
Enterprise data &standard governance
EDC Study Set-up
Submission-ready
SDTM Data & Package
Standards/studycompliance metrics
External data(e.g. public standards)
Structured
Unstructured
ADD Data Standardization and Biometrics: Schematic Overview
Single Source of Truth
ADD Data Standardization and Biometrics
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 © 2021 Tata Consultancy Services Limited
IT ServicesBusiness SolutionsConsulting
To know more Visit the
https://www.tcs.com/advanced-drug-development page on tcs.com
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.
For more information, visit us at www.tcs.com
Cor
por
ate
Mar
ketin
g | D
esig
n Se
rvic
es |
M |
02 |
21
Digital Advangage for Life Sciences
“ADD Data Standardization & Biometrics offers us an opportunity to revolutionize our clinical development by automating the process of converting study data to submission-ready SDTM data.”Head, clinical data standard, top-20 pharmaceutical company
About TCS ADD Platform
TCS ADD is a modern and open drug development platform for life sciences that enables digital
ecosystems, simplifies data complexity and provides faster access to new and effective drugs for
patients in need. The platform is powered by our proprietary cognitive artificial intelligence
engine, data driven smart analytics and Internet of Things (IoT) that makes clinical trials more
agile and safe. TCS ADD leverages the best of cloud architecture and personalized user
experience design in compliance with quality guidelines and privacy regulations.
Awards & Recognition
2019
WINNER
CLINICALRESEARCHNEWS
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