In the current environment where reducing the cost of drug development is paramount, VIBpharma’s Evolution of Data Management in Clinical Trials conference will deliver practical ideas and solutions to help manufacturers and CROs improve their data management processes, increase efficiency and speed time to market. With the global emphasis on cost-saving in 2009, improved data management strategies can deliver the long term cost reductions necessary to survive the current downturn and ensure long term success. Through a series of presentations and discussion from leading manufacturers, this conference will deliver time and cost saving ideas in a wide range of areas including: Maximising the benefits of EDC tools to capture and integrate data across multiple sites in accordance with submission standards Achieving consistent application and implementation of data standards to speed up the trial process Getting to grips with CDISC standards and implementation challenges to develop improved data management standards and satisfy regulatory approval processes Balancing cost and quality considerations when choosing outsourcing partners to help sponsors make the right decision Monitoring and oversight responsibilities and understanding the changing role of data managers in an evolving trial environment Hosted in Washington DC, easily accessible from the pharma and biotech hubs on the East Coast, The Evolution of Clinical Data Management will provide a high-level platform to discuss strategic and operational challenges such as data capture, sharing, integration, standardization and outsourcing.

1. The Evolution
of Clinical Data
Management USA
Implementing CDISC standards and improving
data management strategies to reduce the cost
of drug development
Tuesday 23 and Wednesday 24 February 2010, Washington DC, USA
DISTINGUISHED SPEAKERS INClUDE: TOP COMPANIES INClUDE:
Andy lawton,  GSK  Allergan
Head Clinical Data Management,
BOEHRINGER INGElHEIM UK  Schering Plough  Bristol-Myers Squibb
 Merck  Ariad Pharmaceuticals
Katherine Arbour,
Director Clinical Data Management,  Wyeth  ImClone Systems
ARIAD PHARMACEUTICAlS
 Human Genome Sciences  Boehringer Ingelheim
Terry Katz,  Vertex Pharmaceuticals  Eli Lilly
Vice President, Biostatistics and
Data Management, IMClONE SYSTEMS
CONFERENCE HIGHlIGHTS:
Julia Urbanchuk,
Director, Organizational Development & Change, ★ Outline strategic guidance and provide practical
MERCK
advice on implementing CDISC standards with
Dante Covelli,
case studies from leading manufacturers
Associate Director, Clinical Data Management,
ElAN PHARMACEUTICAlS ★ Discover proven ideas for reducing data
management costs in clinical trials and
Sharon Rittenhouse, working effectively with global partners
Senior Manager, Clinical Data Management,
AllERGAN ★ Evaluate use of EDC tools for improving data
gathering and integration in onshore and
Susan Howard, offshore clinical trials
Assistant Director for Oncology
Data Management,
GSK
Darlene Kalinowski, WORKSHOP HIGHlIGHTS:
Associate Director, EDC Operations,  Peer-to-peer learning environment to develop
BRISTOl-MYERS SqUIBB
improved strategies for implementing data standards
Jane Diefenbach,  Solution led discussions on core standards and
Founder and Steering Committee Member DCDISC, future developments
CDISC
(Pending final confirmation)  Interactive forum to generate cost and time saving
ideas for data management
 Bring your own CRFs and database structures for real
world exercises to improve your submissions processes
Organised by:
Register online now at: www.arena-international.com/pharma/datamanagementusa/

2. Program Day One Tuesday 23, February 2010
08:30 Registration 11:40 Improving trial outcomes through enhanced
communication and collaboration
09:00 Opening remarks from the Chair ● Developing communication strategies to overcome the challenges
Andy lawton, Head Clinical Data Management, of organizational size and trial complexity
BOEHRINGER INGElHEIM UK ● Improving internal processes to facilitate openness and
collaborative working
Streamlining data processes and reducing costs ● Making sense of the data and identifying the trends in clinical trials
● Achieving better outcomes by minimizing errors in data gathering
through the effective application of standards and interpretation
● Ensuring best quality data through enhanced communication between
09:10 Achieving standardisation to speed up clinical trials data managers, statisticians, monitors and clinical investigators
and reduce time to market Sharon Rittenhouse, Senior Manager, Clinical Data Management,
● Why standardise data management? - key drivers and recognising AllERGAN
long terms benefits for the clinical trials process
12:10 Lunch
● The data modeling process and the benefits of adopting CDISC
standards
● Integration and progress on key initiatives including CDASH and Sustainable outsourcing strategies for cost
CDISC HL7 efficient data management
● Reducing timeframes for data management and improving resource
allocation 1:30 Getting best results from outsourced data
● Status on CDISC electronic protocol standard and the impact on CDM management functions
and trial registry processes in the future ● Strategies for achieving cost effective data management in the
Melissa Binz, Director, Central Standards Group, WYETH current economic climate
(pending final confirmation)
● Managing the opportunities and risks of different outsourcing options
● Avoiding costly mistakes by choosing the right partner to fit the
09:40 Overcoming obstacles to standardization to create a needs of your trial
streamlined, interoperable data collection process ● Practical tools and techniques for selecting the right provider
● Assessing the CDASH data collection standard and how it maps to the – understanding the business case for outsourcing and
SDTM vendor capabilities
● Dealing with counter-intuitive naming conventions and problems for ● Keeping control through optimizing timelines and costs in the
SAS programmers data management process
● Outlining practical implementation goals (CDASH-ODM) for better results Speaker TBC
● Facilitating interoperability between clinical systems including data
from Electronic Health Records (EHRs), numerous clinical data systems 2:00 Case Study: Hybrid CRO and sponsor partnerships
and trial sites to produce cost-effective outcomes for global EDC
● Identifying when standards help and when they threaten productivity oncology trials
● Moving forward with uniform standards and building an improved ● Determining the participants and allocating responsibilities and
landscape for clinical data management decision-making to each
Pierre Verroye, Executive Director, Clinical Data Management and ● Understanding the sites relationship with EDC and maximizing the
Clinical Programming, HUMAN GENOME SCIENCES tool’s capabilities
● Determining critical paths for EDC trials that are designed specifically
10:10 Consistency in standards interpretation to reduce for large, global oncology trials
submission errors ● Cost-effective models for CROs and Sponsors that manage data
● Knowledge of evolving standards to ensure smooth submission collection for an EDC trial successfully
processes Katherine Arbour, Director, Clinical Data Management,
● Coordinating in house processes to CDISC standards to ease ARIAD PHARMACEUTICAlS
implementation
● Overcoming pitfalls in using EDC tools for front end data
2:30 Medical Dictionary for Regulatory Activities (MedDRA)
standardization to ensure ease of use for data entry
● Successfully making the journey from case report form to CDISC ● Background of who should subscribe to MedDRA – identifying the
SDTM benefits prior to trial
● Case report from design considerations to ease the creation of CDISC ● Practical steps for facilitating retrieval, analysis and display to
SDTM data sets achieve a suitable balance between sensitivity and specificity within
● Integrating data from multiple sources and managing regulatory the regulatory environment
obstacles ● Applying the release and use schedule of the latest version
Scott Getzin, Data Scientist, ElI lIllY (pending final confirmation) developed by MedDRA Versioning Blue Ribbon Panel: the benefits
for data managers
● An overview of the changes to MedDRA v 12.0 and case studies
10:40 Morning refreshments outlining the version impact
Jean Morrone, Manager, Clinical Data Management,
VERTEx PHARMACEUTICAlS
Improving resource allocation to enhance data
reliability and trial outcomes 3:00 Afternoon refreshments
11:10 Increasing data reliability in a globalize trial environment 3:30 Maximizing the potential of transformation through
● Innovative strategies for coordinating data management functions effective change management strategies
across multiple international trial sites to achieve consistent reliable ● What differentiates successful transformation from failures?
observations and outcomes ● Understanding the human capital side of change for more
● Deciding upon the division of resources for maximum cost productive results
effectiveness ● Going beyond the processes and technology in embedding change
● Outlining practical collaboration tools and techniques to keep the data ● Developing a framework for effective change management to
moving and prevent blockages reduce inefficiencies
● Solutions for monitoring, reporting and administering global trials Julia Urbanchuk, Director, Organizational Development & Change,
Dante Covelli, Associate Director, Clinical Data Management, MERCK
ElAN PHARMACEUTICAlS

3. Program Day Two
Maximizing the use of EDC tools for simpler, 08:30 Registration
cheaper and quicker data management 09:00 Opening remarks from the Chair
Carol Buck, Assistant Director, Clinical Data Management,
4:00 Getting from data capture to a ‘clean’ data set SCHERING PlOUGH
● Establishing a data plan to minimize data leakage and waste in transit
● Taking the data from front end capture to integrated database 09:10 Roundtable morning sessions
without compromising data integrity Delegates will be able to attend three one-hour roundtable discussion
groups from a selection of key topics. Each session will be chaired by
● Collating data from eCRFs, ePRO and EDC platforms while
an industry expert who will facilitate an exchange of opinions, essential
maintaining data safety and privacy
experiences and learning related to a current aspect of data management
● Practical strategies to manage the problem of data sharing and
integration to cut time and cost during trials Roundtable 1
● The use of data cleaning plans to provide a framework for Balancing cost and trial outcomes in outsourcing
data integration data management in a global trial environment
Terry Katz, Vice President, Biostatistics and Data Management, Quantifying the value of outsourcing to reduce
IMClONE SYSTEMS data management costs and building sustainable
relationships with CROs
4:30 How to realize the benefits of EDC in trials conducted Katherine Arbour, Director, Clinical Data Management,
in emerging countries ARIAD PHARMACEUTICAlS
● Successfully managing trial circumstances affecting operability
of EDC tools Roundtable 2
● Overcoming lack of technology infrastructures in clinical trials Is EDC still the default method for data capture?
in emerging countries Is EDC as an enabling tool for data management or creating
● Solutions to communication problems in locations that cannot more problems than solutions?
support EDC Roundtable leader TBC
● Balancing overall trial costs with data capture and integration
considerations Roundtable 3
● Identifying hidden costs of the trial environment - the impact Making data management systems and
on data capture and integration processes work for you to maximize the
Darlene Kalinowski, Associate Director, EDC Operations, potential of electronic tools
BRISTOl-MYERS SqUIBB Key considerations in determining the right data
management tools and platforms for training investigators
5:00 Closing remarks from the Chair and close of Day One and incorporating collaborative visualization techniques
into data analysis
Robert Gordon, Manager, Biostatistics and Medical
Pharmacovigilance, JOHNSON AND JOHNSON
Roundtable 4
Data warehousing for more effective data management
Who keeps what information and for how long? Realizing
the value and usefulness of data after a trial
Susan Howard, Assistant Director for Oncology Data Management, GSK
Roundtable 5
The convergence in the roles of data managers and
clinical investigators
Implications for data management responsibilities
in future trials
Dante Covelli, Associate Director, Clinical Data Management,
ElAN PHARMACEUTICAlS
Roundtable 6
How to better leverage clinical data to drive efficiency
and quality in clinical trials
The use of clinical data to improve the clinical trials process
Terry Katz, Vice President, Biostatistics and Data Management,
IMClONE SYSTEMS
12:30 Lunch
Harnessing growth opportunities in a challenging
trial environment
1:40 Afternoon keynote: Increasing understanding of
CDISC standards to maximize benefits of a universal
data management approach
● Key drivers for standardization and how to argue the case for the
aggressive implementation of global standards
Using CDISC to reduce timelines for data management to analyze and
REGISTER ONLINE NOW!
●
improve resource allocation during clinical trials
● Update on CDISC standards and how they fit with the goals of industry
www.arena-international.com/ ●
and FDA - exploring Protocol, CDASH, SDTM and ADaM standards
Implementing CDISC data standards: how do you know if you got it right?
pharma/datamanagementusa/ ● Implications of the CDISC HL7 standard
Jane Diefenbach, Founder and Steering Committee Member of
DCDISC, WASHINGTON DC CDISC IMPlEMENTATION NETWORK
(pending final confirmation)

4. POST-cONFERENcE WORkShOP
Wednesday 24, February 2010
Techniques and Strategies for
2:10 Facilitating drug development through standardization Implementing CDISC CDASH Standards
● Standardization as a strategy to generate cost savings and shorten
development timelines Thursday 25 February 2010
● Changing data processes to gain a competitive edge in a Led by: kit howard, MS, ccDM, Principal and Owner,
difficult market: a cross-functional approach kESTREL cONSuLTING and Dorothy Dorotheo, Director,
● Accelerating the route to market through streamlined data
clinical Data Management, INTERMuNE
management and analysis: from CRF to data repository
Carol McKenna, Associate Director, Clinical Data Management,
Biogen IDEC
About the workshop:
CDISC CDASH standards are set to shape the future of data management as the
industry moves towards a more consistent approach to managing the vast amount
Reducing the time to market through the use of EHR of data generated during a trial. However developing an effective implementation
strategy that incorporates in-house processes is a huge challenge.
2:40 Using Electronic Health Records (EHR) to enhance the
Through a combination of lectures and hands-on exercises, this workshop will
clinical trials process provide an interactive environment for you to discuss the various challenges
● The EHR landscape in the US and implementation goals to accelerate of implementation. Attendees are encouraged to bring a sample Concomitant
clinical research Medications CRF and the associated database structure in order to conduct a
● The benefits and challenges of the secondary application of EHR data real mapping exercise. The workshop is intended to enable practitioners to share
experiences with peers on how best to move forward in making processes fit the
in clinical research
CDASH model and speed up data submissions.
● Developing an understanding for the need of profile supporting for the
use of EHR systems in clinical research Students will receive:
● An integrated approach to the use of EDC tools to increase efficiency 1. Slide deck of the presentation materials
at the point of patient contact in order to speed up the lengthy 2. Tools for performing the mappings
medicine development cycle
● Overcoming challenges in EHR interoperability from a legal, technical, Workshop learning objectives:
organizational, financial and political stand point. 1. Understand the content of CDASH
● ‘Real world’ lessons learnt from connecting electronic healthcare and 2. Understand the data structure philosophies behind the standard
research systems 3. Learn how to map CDASH into SDTM, including each field existing in
Susan Howard, Assistant Director for Oncology Data Management, GSK CDASH and not in SDTM
4. Learn how to map sponsor CRFs into CDASH with results that are both
3:10 Afternoon refreshments CDASH and SDTM conforming
The future of drug development - a patient centred Workshop agenda:
approach to new treatments
09:00 Registration
3:40 Maximizing the benefits of collaborative visualization
(CV) from small to large trials 09:30 An overview of CDISC CDASH standards -
● Techniques to take data review to the next level by identifying what The relationship between CDASH and SDTM
makes a good CV tool
● Building CV into processes to generate more cost-effective data 10:00 SESSION 1:
analysis solutions
● How to map from CDASH to SDTM
● Using CV for early detection of problems
Knowing each person’s responsibilities and using data visualization
●
10:45 Refreshments
systems to facilitate team awareness and improve decision making
Andy lawton, Head Clinical Data Management, BOEHRINGER INGElHEIM
11:15 SESSION 2:
Making the most of trends and changing roles ● How to map from CDASH to SDTM
in data management 12:00 SESSION 3:
4:10 Improving the metrics and coding for ● How to map sponsor CRFs to existing CDASH domains
data management
● Aligning operational metrics with organizational goals for 12:45 Close of workshop
measurable outcomes
Exchanging metrics between different groups and systems within
About your workshop leader:
●
an organization
● Developing applications to capture and analyze metrics across all Kit Howard has 25 years of experience in the industry, and extensive experience
data management functions to reduce costs in the design, implementation and maintenance of cross-functional clinical data
standards. She is a member of the CDASH Core management team, the CDISC
● Using tracking and metrics tools to monitor real-time data retrieval
Devices team, and the CDASH ODM development team, and is a long-term
● Speeding up the process of observations and centralization of member of the Society for Clinical Data Management’s Editorial Board. She
data to reduce time lags in clinical trials has spoken and published extensively on topics related to standards and data
Pierre Verroye, Executive Director, Clinical Data Management and quality, and is passionate about the potential for standards to revolutionize the
Clinical Programming, HUMAN GENOME SCIENCES way we bring treatments to patients.
Kestrel was established in 2003, and specializes in clinical data standardization
4:40 Strategic changes to the role of data managers in an and clinical data quality. With a select network of consultants, Kestrel provides
both consulting and educational services to the biopharma and medical devices
EDC environment industries, especially in the area of CDASH implementation.
● Interpreting the roles of clinical investigators, CRAs and clinical data www.kestrelconsultants.com
managers and the need to cooperate
Dorothy Dorotheo has over 27 years of clinical development experience including
● Clarifying the responsibilities of professionals gathering and clinical and data management, project management, CRO outsourcing and
interacting with data oversight. She has extensive experience in spearheading the establishment of
● EDC as a catalyst for convergence in data management functions and company standard data collection instruments through creation, implementation
understanding the impact on clinical trials and maintenance.
● Challenges and solutions for managing multiple entry and access Dorothy is a member the CDASH Core management team, leading one of the first
points to maintain overall data reliability CDASH domain streams, Prior and Concomitant Medication domain as well as the
CDASH ODM development team. She is a certified clinical data manager (CCDM).
Speaker TBC
Over the years, she has acquired additional training in clinical trial management,
CDISC (SDTM & ODM), GCP, document management, project management, eCTD
5:10 End of day two and close of conference submission, communications and other clinical development related topics.
Dorothy is a member of DIA and SCDM. www.intermune.com

5. Media Partners: About the Conference
Biocompare is the most comprehensive, in-
In the current environment where reducing the cost of drug
depth, and objective website for life science
development is paramount, Arena-International’s Evolution
product information. Thousands of scientists
of Data Management in Clinical Trials conference will deliver
use Biocompare daily to quickly find the right
practical ideas and solutions to help manufacturers and CROs
product for their experiments rather than looking through multiple print
improve their data management processes, increase efficiency
catalogs. Visit our site to find the products you need, stay informed
and speed time to market.
of new technologies, read product reviews, watch product videos, and
keep up-to-date on life science news. www.biocompare.com With the global emphasis on cost-saving in 2009, improved
data management strategies can deliver the long term cost
Pharmaceutical Business Review: reductions necessary to survive the current downturn and
The Business Review websites are your number ensure long term success. Through a series of presentations
one stop for all the latest news, comment and and discussions from leading manufacturers, this conference
industry information. Each Business Review will deliver time and cost saving methods for improving your
website offers content that is produced by a dedicated team of data management processes.
journalists and global industry experts. In addition to the free content
made available on the sites an intelligence store will provide you with
premium market analysis reports from the leading global suppliers of Who should attend
market research and industry analysis.
The audience will be made up of Vice Presidents,
Pharmaceutical Business Review is the world's leading pharma Directors and Managers within pharmaceutical and
website, being used by over 100,000 visitors every month. For further biotech manufactures from the following areas:
information contact jsharp@industryreview.com
● Data Management
Pharmaceutical Technology is used daily as ● Outsourcing
a means of creating partnerships and as a
● Clinical Operations
point of reference by professionals within the
pharmaceutical industry. This comprehensive resource supplies the ● External Alliances
latest news releases, detailed information on industry projects, white ● Clinical Trials
papers, event information and a thorough breakdown
of products and services. www.pharmaceutical-technology.com ● Clinical Research
● R&D
Supporting Association: ● Project Management
ACDM - Association for Clinical Data ● Contracts
Management: We are a not-for-profit organisation ● Legal Counsel
that represents and supports professionals
involved with managing clinical data from within
the pharmaceutical, biotechnology and academic research fields. At the
hub of ACDM activities, our website offers a diverse, valuable resource
for all levels of professional people managing clinical data. We aim to
promote best practices, share knowledge and assist with the professional
development of our growing membership. www.acdm.org
CDISC (Clinical Data Interchange Standards
Consortium) operates to advance the continued
improvement of public health by enabling efficiencies
in medical research and related areas of healthcare.
As a catalyst for productive collaboration, CDISC
brings together the individuals spanning the
healthcare continuum to develop and support global, open, consensus-
based medical research data standards. The CDISC standards are freely
available via the CDISC website at www.cdisc.org
Co-sponsor:
Do you wish to exhibit your products and
services at this exclusive event?
We have a number of promotional packages available
from exclusive sponsorship through to exhibition
stands and inserts in the documentation, with
competitive prices to suit all budgets.
If you wish to be part of this high-level event, please
contact: Jaz Sidhu, on +44 (0)20 7753 4259 or by
email at jazsidhu@arena-international.com

6. BOOKING FORM
The Evolution of Clinical Data Management USA, Tuesday 23 and Wednesday 24 February 2010, Washington DC USA
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