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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