1) The document discusses challenges facing the clinical development process for pharmaceutical companies, including high costs, lengthy timelines, and increased regulation. 2) It proposes that implementing strategies like electronic data capture, data standardization, and centralized data management can help accelerate clinical development and lower costs. 3) The key is developing a holistic, long-term strategic framework for clinical information management that streamlines processes, integrates data, governs data standards, and supports strategic decision making.

1. THE ADD (ATTENTION DEFICIT DISORDER) EFFECT
IN CLINICAL DEVELOPMENT
Authors: Sanjeev Wadhwa and Sanjay Modi
• The Tufts Center for Establishing the Strategic Framework for Clinical
the Study of Drug
Development suggests
Information Management: A Holistic Look Through
that the R&D pipeline the Lens of a Future Operating Model
might be rebounding
as the leading U.S. Industry Trends
drug companies have Clinical development is a complex process for pharmaceutical companies
increased their clinical which bear a high cost to reap the final rewards of potentially billions of
trials numbers by dollars after FDA approval. The process can take up to 12 years and
greater than 50 requires a great deal of communication and coordination. Clinical data
percent has to be properly collected, managed and reviewed in order to obtain
full value of the results. The current industry is facing numerous
• Frost and Sullivan
challenges such as increased number of generics due to patent
estimates that the
expiration, limited late-stage pipeline drugs, lawsuits, payer influence and
global pharmaceutical
increased government regulation which lead to decreased profits. It
R&D outsourcing
needs to find ways to reduce costs in order to be more efficient.
market will grow to
$24.9 billion by 2007 • Total global spending on clinical development (Phases I-IV) is about
• The Tufts Center for 34 percent of total R&D costs
the Study of Drug • Only three out of every 10 marketed drugs produce revenues that
Development suggests match or exceed initial costs
that the R&D pipeline
might be rebounding
$3,000
as the leading U.S. $2,722
drug companies have
$2,500
increased their clinical
(Millions of 2000 Dollars)
trials numbers by
After-Tax Present Value
$2,000
greater than 50
percent $1,500
• Frost and Sullivan $1,015
estimates that the $1,000
global pharmaceutical $629
$433 A fter T ax R & D C o sts
R&D outsourcing $500
$235
$126
market will grow to $56 $30 $9 $0
$0
$24.9 billion by 2007 1 2 3 4 5 6 7 8 9 10
New Rx Drugs Introduced Between 1990 and 1994
Grouped by Decile According to Sales
Figure 1: Source: H. Gabrowski, J. Vernon, and J. DiMilasi, “Returns on Research
and Development for 1990s New Drug Introduction,” Pharmacoeconomics 20
(December 2002): suppl. 3, 11 – 29
| The ADD Effect in Clinical Development | 1

2. External Drivers
$U S (M illions)
New Data Types
$1,200 • ClinPharm, M&S, Genomics and Proteomics
Evolution of Industry Standards
$900 • Data Standardization
– XML, HL7 and RIM
$600
– Global Library Standards
– CRF templates
$300
– Medical versus FDA and ICH Analysis needs
$0 Strategy Partnering
1991 1997 1999 2003 2004 • Outsourcing
Source: Arcarya, 2006. Pharmalicensing • Data sharing
Figure 2: Escalating R&D Costs: Cost of Developing an NME • Data Aggregators
Regulatory and Ethical Requirements for Safety and
• Rising costs of NME development (2006) Post-Marketing
• The Tufts Center for the Study of Drug • Document submission
Development suggests that the R&D pipeline – CDISC versus Generic Data Model
might be rebounding as the leading U.S. drug
• Adverse event signal generation and coding
companies have increased their clinical trials
numbers by greater than 50 percent Federal Information Technology Impact
• Health Information Technology Impact
• Frost and Sullivan estimates that the global
pharmaceutical R&D outsourcing market will – Pay for Performance
grow to $24.9 billion by 2007 – Evidence Based Medicine
• The Tufts Center for the Study of Drug – E-Prescribing
Development suggests that the R&D pipeline – Electronic Health Records
might be rebounding as the leading U.S. drug
Long-term benefits of these drivers will lead to an
companies have increased their clinical trials
acceleration of the drug development process and a
numbers by greater than 50 percent
development of an integration framework to closely
• Frost and Sullivan estimates that the global monitor clinical data.
pharmaceutical R&D outsourcing market will
grow to $24.9 billion by 2007 Key Accelerators
Clinical Data Capture
Clinical Study Management Challenges EDC is evolving into a standard in the drug
Internal Drivers development process to electronically capture clinical
Streamlining Internal Processes data and support large trials. EDC techniques can
• Increase clinical development operating cause a 25 percent reduction in the effort compared
efficiencies to paper based trials along with reducing labor costs.
• Corporate mandate to decrease costs One advantage of EDC allows companies to make
• Need for retrospective and prospective metrics drug safety decisions during earlier stages of
development with current information. The
Massive Data Analytical Burden technology also incorporates lab data processing,
• Variant data capture techniques to move data performs multivariate checks across different CRFs
capture closer to the patient — EDC, CDMS, for proper data identification, and handles batch
e-Sourcing, etc. validation updates and adverse event coding needs.
• Data definition for internal and external use These capabilities permit on-line solutions with data
• Data transformation entry capability with various entry points and data
exchange with remote clinical trial sites.
Application Portfolio Diversity/Legacy
• Enhance business agility
• Increase application re-usability
| The ADD Effect in Clinical Development | 2

3. File NDA at FDA File NDA at FDA transformation and standardization process are
important factors, especially within a multi-user
Pre-clinical environment and for data sharing with external
Phase I Phase II Phase III FDA Phase IV
Testing partners.
Strategy Clinical Clinical Clinical Submission SAE Another key factor for accelerating clinical
Planning Data Data Data Preparation, Handling
• Clinical Capture Management Review Review and
development is data standardization so translation of
R&D Approval information is well defined. If this is not implemented,
• HIT
this could lead to variability downstream and result in
Involves applications and individuals from many groups errors in data analysis. CRF design and templates are
and demands a high-level of communication and coordination. essential to minimize different versions of the same
form increasing variability. A knowledge management
Figure 3: Clinical Study Management Value Chain system could be implemented to leverage previous
CRF templates resulting in fewer resources and
decreased time commitments to “reinvent the wheel.”
Industry experts estimate full implementation of EDC Data standards need to be driven by requestors such
in the next 12 to 24 months with lower barriers and as the FDA and the needs of the organization such as
more offerings. The larger pharmaceutical companies medical analysis by implementing a CDISC model for
have goals for implementation of EDC and to go 75 collecting, storing and processing the data from
to 80 percent paperless in the next 12 to 18 months the trials.
(Brooks, 2006).
CDISC.org recognizes the importance of data
Merck Capital Ventures and SAIC reports that standards for the submission and review process for
Novartis utilizes EDC in 60 percent of Phase I trials the FDA. It has worked with the FDA and Eli Lilly for
and almost 100 percent of Phase II and III trials. This an analysis of mock submissions in order to create a
has led to a reduction in contractors for data working prototype for the submission of electronic
management from 90 to 20. There is also a decrease data that meets the needs of the FDA reviewers. The
in the number of queries to four per 1,000 data end result will be faster review times by the FDA and
points versus 51 per 1000 when there were paper- a decrease in costs by companies. In addition it will
based trials. The costs associated with the new help regulatory agencies identify drug interactions.
system are dramatically lower. The cost per page
Proper analysis of the data is a key factor in Clinical
goes from $23 to $4.60 when shifting from paper to
Data Intelligence. An established data repository with
EDC. In addition, the time needed for database lock
proper maintenance supports large trials and data
went from 10 weeks to 4 days with EDC. The annual
processing. Standard information is utilized in
savings is in excess of $100 million (Roner, 2006).
downstream analysis and transformations in order
Another way EDC processes are evolving is with the to input additional data. The data can also be
introduction of e-sourcing. Data capture at the leveraged in modeling and simulation for bio-
patient’s bedside results in more accurate capturing statistical analysis. CDISC Compliant Repository is not
of patient information. Paper writing by the staff and only a submission repository but also a clinical data
then transcription is no longer necessary. This results management repository which can be further utilized
in less medical and prescription errors along with for additional analysis.
better medical care management by increasing
With multiple investigator sites, clinical trial
patient safety.
management consists of having the ability to also
Clinical Data Management manage and track these studies at the various
Once all the data is collected utilizing the latest locations. The clinical trial information should be
methods, it has to be properly managed in order to shared and recorded. Any additional administrative
create value in the process. With multiple and even information should be relayed to the users relatively
global locations, real-time technology should be quickly so delays will not occur in the development
implemented for capturing any changes at any given process. Therefore it should be feasible for global
time. The ability to merge data from different scheduling and coordination and protected with
databases and adapt to new versions are necessary security features to make it compliant with the
as well. Defining and streamlining the data current rules and regulations.
| The ADD Effect in Clinical Development | 3

4. Clinical Data Exploration/Review
The patient data review process allows the ability to
look at data across all the trials implemented by the
ie s e
company. This is enhanced by a strong graphical
nc ar
Care Providers
ge lthc
report feature to visually see a layered view of all
Pu
(Public Sector/
y A ea
patient data across the trial timeline. If there are
bl
or t H
Commercial)
ic
safety issues, then proper design implementation will
la t e n
He
gu m
al
result in safety signal detection when reviewing the
Re vern
th
Ag
data. An adverse drug event system can collect,
Patients
Go
en
assess and report this event. This system will be able
ci
es
to identify minor and major events to implement the Pharmaceutical/
Payors
proper steps. Medical Product
Manufacturers
With data standardization, there will be ability for
batch processing functionality resulting efficiency in
reviewing data for specific endpoints. The data Information Technology
should also be ready for submission to the FDA via
PDF and be 21CFR 11 compliant for proper quality Figure 4
controls. It should be easily searchable, be dynamic,
and have the ability to create, track and accept
responses from queries sent to the clinical manager
Strategic Framework for Clinical
for review. Proper EDC/CDM system implementation Information Management
can reduce Discrepancy Management as an issue to Due to the high costs of Research and Development,
make sure all necessary information has been entered companies must execute new strategies for efficient
so more accurate results are obtained from the data. clinical information management to drive operating
This also results in less time and costs when efficiency and meet future R&D and regulatory
reviewing the data. requirements. These new changes lead to a more
strategic framework for planning and decision making
The increase use of HIT enables the improvement of along with an emphasis on organizational change
quality, safety and cost-effectiveness of healthcare. It management. There needs to be a focus towards the
optimizes the clinical study design by allowing development of a vision and strategy which
researchers to analyze the clinical records of a emphasizes a strategic roadmap leading to a long-
population and evaluate protocol designs before term sustainable advantage.
engaging the resources and costs into a clinical
program. There will faster recruitment of patients as
the sponsor can access eligible patients directly. Culture
Controlled product launches will allow companies and
regulators to push the drug to market faster as trial Vision and Strategy
patients are monitored more effectively. The
adaptation of evidence-based medicine guidelines Governance
factors real-world outcomes and costs while health
Process
management models better gauge health risks and
diseases within the healthcare network. Also, Relationships
performance-based contracts can be tracked to tie
reimbursement to outcomes and cost of care. Finally, Organization/People/Skillsets
personal health records can allow patients to make
knowledgeable healthcare decisions, mange their Applications and Technology
health, and enroll in studies.
Finance
Location
Analysis Framework for Future Operating Model
Figure 5: Analysis Framework for Future Operating Model
| The ADD Effect in Clinical Development | 4

5. A commitment by management to develop and closer review of a “data concierge” type enterprise-
execute a holistic, top-down, process-oriented wide governance mechanism for management and
strategy is essential for success in the competitive enforcement of data standardization, delivery and
landscape. This will result in accelerating clinical drug handling will lead to a decrease in silo-ed operational
development while lowering research and modality. Functional silos have limited information
development costs and faster revenue generation. sharing and communication available to discuss any
business issues that overlap other departments. This
$U S (M illions)
view of decision-making results in a system which is
supported by diverse, inefficient and fragmented
metrics. The lack of cross-functional data
1000 C o st C u rve
requirements definition process does not allow
800
proper leveraging of good practices among its
600
affiliates and partners. This results in an inability to
400
support the changes necessary to address strategic
200 R e ve n u e C u rve influences and opportunities. An appropriate cross-
functional governance mechanism for strategic
I II III IV architecture framework development and
P h ases C ost C urv e C h a n g e maintenance should drive operational efficiency.
R ev e n u e C urve C h a n g e
Process
C h an g e s in R e ven u e an d C o st C u rve D u e to D ru g
D e ve lo p m en t A c c e leratio n Unclear process definitions and complex data loading
processes can lead to inefficiencies in the clinical
Figure 6: Changes in Revenue and Cost Curve Due to Drug development process. A global process alignment
Development Acceleration based on core competencies can lead to a focus on
process ownership rather than a system ownership.
Vision and Strategy This can define data flow processes to address the
One of the first stages of a strategic framework future needs of modeling and simulation, medical
involves the development of a top-down, process- analysis, and biostatistics data needs. New decision
centric vision and strategy which leads to a roadmap criteria can be incorporated on new trials
and a sustained movement towards a Plan, Build and implementing patient bedside EDC as part of a
Operate Model. This requires process-based scalable implementation plan. A technology
organizational alignment and change management. A evaluation and selection process is required to
migration toward architectural simplification and a manage introduction and retirement of applications.
data integration framework will streamline data In order to streamline the process, an initial step is to
processing and discrepancy management resulting in consolidate the application portfolio into a few
application consolidation. strategic applications and implement a generic,
A strategic plan is necessary for future data flexible data processor for external partner data
management in which the development of an overall transformation needs. Furthermore, quality checking
information management strategy will meet future of data in data loading processes is required to
needs, along with a three- to five-year roadmap will ensure lesser number of discrepancies downstream.
create an advantageous long-term strategy. Another Conducting an on-going analysis of the process for
key factor is the examination of the industry and data review should eliminate organizational, process
government initiatives to determine how these will and data repository redundancies. A continuous
affect the industry and the steps needed to remain evaluation of impact from strategic influencers,
competitive. leveraging new trends and examination of the entire
value chain for clinical data management will lead to
Governance an efficient processing system.
Companies lack an enterprise-wide governance
mechanism for the management and enforcement of Relationships
its initiatives. A necessary step is to determine an Expanding beyond an external partnership that is
appropriate cross-functional decision-making transactional in nature to one that is a strategic
authority for strategic roadmap approval, execution partnership can enhance the clinical information
and oversight. This involves incorporating management process. Key competencies can be
development towards a strategic architecture with enhanced by leveraging strategic partners. For
enterprise-wide data handling and standardization. A example, the lab data management process can be
| The ADD Effect in Clinical Development | 5

6. conducted with a lower number of central labs which Other initiatives such as EDC are supported by
deliver data in one format. A critical review of lab reallocation of existing workers. An examination of
partnerships and CRO contracts is essential in the data custodianship will lead to process ownership
process in order to get the data transformed into rather than system ownership. Finally, an evaluation is
usable data. necessary to evaluate core competencies to decide
which ones will be kept in-house. This assessment will
In addition, knowledge from other partners and
determine its culture and organizational readiness for
affiliates can be beneficial as a learning tool. Also,
strategic change.
there should be a determination whether it is
advantageous to promote an external vendor’s EDC Applications and Technology
product strategy and development. An external Another part of the operating framework is the
vendor’s strategy might not meet the strategic focus incorporation of data standardization utilizing new
of the company. Another benefit of relationships is applications and technology. All incoming data can
the alignment of internal capability building plans to be set to use XML and these standards can be
external opportunities by participating in external established depending on the analysis needs. There
industry and government initiatives (NAHIT). has to be an enforcement of global standards and
increased knowledge and utilization of CRF templates
CROs can decrease costs and increase savings which
which would alleviate the problem of CRF disparity
can be utilized for strategic initiatives by the
and non-standardization. The consolidation of several
company. Companies can concentrate their resources
functionality-aligned tools into fewer, enterprise-wide
toward core competencies to create a competitive
data review tools for data searching, discrepancy
advantage while outsourcing their non-core skills.
management, and patient data review would create
This can lead to dramatic cost savings along with
sharable and scalable solutions with less human
access to expertise-level staff leading to productivity
interface. A business process management layer
gains and process improvements. A recent study by
could decouple workflows from data storage and
Tufts Center for the Study of Drug Development
integration layers.
shows the increasing reliance on CROs by drug
companies. CROs offer an advantage to companies Implementation of role-based access to decision-
while providing new insight who do not have recent making information allows the designated users to
experience in a specific therapeutic area. They help look at all trial data and safety signaling. If there is
reduce R&D costs and utilize the rise in global ambiguity in documentation outlining end-to-end
capacity needs. The study states that companies that process/architectural relationships and impacts, there
extensively use CROs result in completing projects needs to be a development of technical
faster during study close-out period while realizing documentation writing guidelines.
comparable quality to companies that don’t rely on
Regarding database options, a single reference
CROs. Also, the FDA receives submissions more than
database is ideal which can also import converted
30 days earlier than the projected date than those
lab data from outsourced study data. This will allow
who have low CRO usage.
easier access to all clinical data in the system and
CROs are involved in 23,000 Phase I – IV trials. In provide standard information to end users for
2004, $5.5 billion of global R&D spending went to analysis. A review of in-house data models could lack
clinical CROs. CROs are becoming critical for cost the benefits that a standard CDISC would provide
savings for companies to focus on their core such as interoperability between its external partners.
competencies (Getz, 2006). An industry standard would allow easier data
management and integration needed for managing
Organization/People/Skillsets
data and satisfy needs for medical review and
A movement toward the Plan, Build and Operate
planning.
Model creates a new strategic “plan” function
(through reallocation of existing workers) supporting Furthermore, SaaS can allow users to access data in
a strategy toward development and management of real-time with low initial activation costs and
enterprise architecture. This will be a separate group resources that avoid the high costs of purchasing
and mandate with appropriate budgeting and hardware needed to set up an infrastructure needed
funding. Furthermore, there is management of for an application. The timeframe for implementing
organizational change through all enterprise-wide systems for clinical trials management is much
initiatives. Workers have clearly defined roles and smaller leading to faster access and analysis of data.
responsibilities while training and matching of skill set Furthermore, management of the system is pushed to
to applications. the vendor so companies can focus on the core skills.
| The ADD Effect in Clinical Development | 6

7. Finance Conclusion
The annual budget needs to be driven by a strategic The Research and Development process is a very
vision and not just break-even goals and be costly process with limited upside potential weighing
accounted for its data management practices. Multi- heavily on a FDA-approved drug. Strategic change
year budget planning that is conditional upon and organization of the Clinical Information
achieving strategic milestones is clearly understood Management capabilities can lead to operational
by workers and should have attainable goals and efficiencies and realized cost savings for
endpoints. In order to properly judge the economic Pharmaceutical companies. A Plan, Build and Operate
impact of a data transformation system, companies Model created, supported by process-based
can conduct financial impact assessments of the non- organizational alignment and change management, is
standard data models and measure the costs for a key driver to create a foundational framework for
maintaining a set of inefficient data management enabling future capabilities. This model will sustain a
processes and nonstandard data repositories. The long-term information management strategy and
end result could push a need for standardization due communications while permitting strategic enterprise
to the cost savings calculated from the assessment. planning and project prioritization. Furthermore, it
will create a cross-functional governance model for
Location
clinical data standardization, management and reuse
With the growing trend of firms located in different
functionality. This will enhance the existing resources
parts of the world, there is an issue of location-
and create additional value to reach long-term goals.
specific processes and tools which create
inefficiencies as there are separate instances of tools
utilized in each global location and the lack of global
consistency. There are also performance issues within
global locations due to architectural and application
limitations leading to global issues. One way to
alleviate this issue is to investigate and pilot other
database architectures and outline performance
Service Line Agreements to enhance investigator
satisfaction while ensuring less discrepancy
management by data managers.
| The ADD Effect in Clinical Development | 7

8. Abbreviations
21CFR 11 Title 21 Code of Federal Regulations
CDISC Clinical Data Interchange Standards
Consortium
CDM Clinical Data Management
CDMS Clinical Data Management System
CRF Case Report Form
EDC Electronic Data Capture
FDA Food and Drug Administration
HL7 Health Level Seven
ICH International Conference on
Harmonization
M&S Modeling and Simulation
NAHIT National Alliance for Health Information
Technology
NME New Molecular Entity
R&D Research and Development
RIM Reference Information Model
SAIC Science Applications International
Corporation
XML Extensible Markup Language
SaaS Software as a Service
| The ADD Effect in Clinical Development | 8

9. References Smith, Laura. 2006. The Six Sigma Cure. Quality
Acharya, Satish. 2006. The Productivity Tiger — Time Digest.
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_44bfac02291f1. of New Drugs. InformationWeek.
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Drug Approvals. tml?articleID=21700481.
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estudy.pdf. Product Development.
Brooks, Kristen. 2006. CRO Update- Growth, http://www.allp.com/drug_dev.htm..
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http://www.contractpharma.com/articles/2006/05/cr Clinical Trials.
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Getz, Ken. 2006. CROs Usage Associated With Faster ww.centerwatch.com/professional/cw_commentary.ht
Drug Development Speed At Comparable Quality, ml+EDC+drug&hl=en&gl=us&ct=clnk&cd=10.
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48215.
9

10. About CSC’s Life Sciences R&D Solutions Enterprise Technology Integration (ETI) — Our ETI
Our solutions span the entire range of drug Practice focuses on business systems strategy — we
development, from basic research at the cellular and align the business system strategy to business and
molecular levels to human clinical trials of potential organizational strategies to ensure that technology is
medicines that prevent and cure disease. CSC’s Life not implemented for the sake of technology; rather,
Sciences R&D solutions encompass: it serves the business strategy set for R&D. Our
solutions focus on:
Strategy and Process Innovation (SPI) — Our SPI
Practice links business and organizational strategies • Enterprise Content Management — We provide
for R&D to deliver process innovation that solutions that help collaborate, control and
dramatically increases throughput in clinical comply to 21 CFR Part 11 and global regulatory
development. Our proven solutions in this space bodies. Our expertise includes EDMS strategy,
include: migration, optimization, eBLA, eCTD, SPL, and
PIM. Our thought leadership in this space and
• Adaptive Clinical Trials — We provide consulting
our 14 years of expertise in this arena help our
and industry expertise to reduce dead time
clients achieve superior results
between phases. We effectively leverage
modeling and simulation to reduce number of • Clinical Research Data Management — For
patients in trials and help conduct in-silico trials, structured data, our team provides drug
where appropriate — resulting in cost take-out development data management solutions that
and shortened development cycles are ICH, HL7 and CDISC compliant. These
systems provide a better way to manage data
• Phase I Outsourcing — Through our division,
from labs, CROs, and imaging firms and enable
Dynport Vaccine Corp. (DVC), we provide clients
our clients to achieve significant efficiency and
the ability to outsource entire Phase I studies.
productivity improvements for the R&D
We provide the program management,
organization
quantitative measures to reduce time and costs,
and proven process that enables clients to
conduct more trials effectively. We currently For more information, visit
manage 11 such trials www.csc.com/lifesciences.
• In-Licensing — We implement strategies and CSC
cutting-edge solutions to help pharmaceuticals Life Sciences Practice
and biotechs take full advantage of in-licensing 1160 West Swedesford Road, Suite 200
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left unnoticed, and potential blockbuster
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• Bioinformatics Partnership — With the rise of
commercial genomics, companies need to
differentiate themselves from competition by
efficiently managing biostatistics analytics and
bioinformatics. CSC’s Life Sciences Practice
serves as a strategic services partner to the
client and provides standards-driven
bioinformatics solutions both through our U.S.
and Indian operations and our strategic alliances
with key partners
• Anti-Counterfeiting Solutions — We leverage our
expertise in defense, consumer products, and
supply chain to deliver novel solutions for
solving the expensive and ever-increasing drug
counterfeiting issues. Our strategy and solutions
go beyond the traditional RFID-based solutions
and provide quantifiable ROI
| The ADD Effect in Clinical Development | 10

11. About the Authors
Sanjay Modi
CSC Life Sciences
+1.973.243.0023
smodi@csc.com
Sanjay Modi works in CSC Life Sciences R&D
Solutions and is based in New York City. He holds a
MBA from The University of Maryland and a
Bachelor’s of Arts degree in Biology from The
University of Delaware.
Sanjeev Wadhwa
CSC Life Sciences
+1.973.243.0023
swadhwa@csc.com
Sanjeev Wadhwa is a partner and senior strategy
expert within CSC Life Sciences R&D Solutions.
| The ADD Effect in Clinical Development | 11

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