Through a series of interactive discussions and presentations by the leading manufacturers, the agenda will cover all the key topics facing data management professionals today including: Utilising EDC tools to integrate data across multiple sites to reduce the risk of data loss Assessing collaboration between partners during the trials process for seamless sharing of information without comprising confidentiality and data integrity Understanding CDISC standards and implementation challenges to develop improved data management standards and reduce the time to market for new treatments Making the right decision on cost and outcomes in data management when outsourcing and working with service providers in emerging markets Staff development and change to management processes to maximise the use of resources Improving data management strategies requires a thorough understanding of industry trends, technological developments, evolutions in regulatory frameworks and data standards. The benefits of continuous improvement in data management strategies are very clear – getting products to market through the quickest and most cost efficient way possible without risking the chances of getting regulatory approval. Located in Munich, a central hub of the manufacturing and CRO industry, VIBpharma’s Data Management in Clinical Trials conference will provide a high-level platform to generate ideas and solutions to make the best use of data management resources and improve processes during clinical trials through to submissions for regulatory approval.

1. 2nd Annual
The Evolution
of Clinical Data
Management
Meeting the challenges of data integration and
standardisation in a changing trial environment
Tuesday 17 and Wednesday 18 November 2009, Munich, Germany
AGE
INClu NDA
DISTINGuIShED SPEAkERS INCluDE: SPEAk DES 17
Dr Johann Pröve, Global Head Data Management, MANu ERS FROM
BAyER SChERING PhARMA
ACRO FACTuRERS
SS
AND T EuROPE
Niels Both, Member of CDISC e3c,
EuROPEAN CDISC COORDINATING COMMITTEE hE uS
Wolfgang Summa, Member of CDISC e3c,
EuROPEAN CDISC COORDINATING COMMITTEE
Beat Widler, Global Head,
Clinical Quality Assurance, ROChE CONFERENCE hIGhlIGhTS:
★ Guidance on implementation of CDISC data
Mats Sundgren, Principle Scientist,
ASTRAZENECA
standards with case studies from leading
manufacturers
Jane Clarke, Assistant Vice President, ★ Practical tools to enhance information sharing
Global Development Support, WyETh and data integration and help CDMs and clinical
investigators improve the clinical trials process
Wafaa Agoumi, European System Quality Manager, ★ Expert led roundtable sessions on the
SANOFI AVENTIS
fundamentals of data management to identify
Silvana Cappi, Executive Director of Biometrics,
valuable improvements to processes to save
FERRING PhARMACEuTICAlS time and cost
lotta Sellen, Director Data Management Hub,
ASTRAZENECA
WORkShOP hIGhlIGhTS:
Francis kendall, Head of Statistical Programming,  Practical peer-to-peer learning environment
ROChE
 Solution led discussions on core standards
 Interactive forum to generate cost and time saving
Stefan Beimel, Global Clinical Biometrics, Section Head
Clinical Data Management, MERZ PhARMACEuTICAlS ideas for the implementation of CDISC standards
Fritz Maritsch, Director Global Clinical Data Gold sponsor: Sponsor: Sponsor:
Management, BAxTER
Dr Ferdinand hundt, Director Clinical Operations and
Medical Affairs, SANOFI AVENTIS Organised by:
VIBpharma
Register online now at: www.pharmadata-event.com

2. Programme Day one Tuesday 17 November 2009
08:30 Registration ● Case study example: integration of j-review for cleaning and
09:00 Opening remarks from the Chair reviewing medical data
Jane Clarke, Assistant Vice President, Global Development Martin locher, Technical Project Manager,
Support, WyETh BOEhRINGER-INGElhEIM
Carina Soldner, Project Manager, BOEhRINGER-INGElhEIM
MEETING ThE DATA INTEGRATION ChAllENGE TO
REDuCE ThE COST OF ClINICAl TRIAlS 11:40 leveraging industry standards to ensure the effective
implementation of a user-friendly, standardised
09:10 Morning keynote: Significantly improving data quality Clinical Data Warehouse (CDW) system
and integration across multiple entry points to enhance ● Highlighting the advantages of creating a well structured CDW
organisational compatibility ● Implementing a CDW using an enhanced Janus data model
● Linking the systems used for data management tasks (EDC, ● Case study: Nycomed’s implementation of a CDW using an
e-diaries, other data capture devices) to obtain better patient Oracle Life Science Data Hub
information during clinical trials ● Fast-tracking CDW implementation and reducing project risks
● Ensuring that the data is reliable prior to integration by leveraging standardised CDW components and design
● Effectively managing different points of data entry and ensuring Philip henrik Puls, Senior Project Manager, NNIT
quality is monitored
● Interpreting inconsistencies created by multiple patient 12:10 Reducing data leakage and waste at the
observations and associated problems for statisticians and investigational site: making the most of your resources
analysts ● Developing a strategy with clinical investigators to minimise
● Considerations in remote data capture for data managers, the risk of data loss
clinical investigators and third parties ● Identifying opportunities for the seamless integration of
Jane Clarke, Assistant Vice President, Global Development on-site data
Support, WyETh ● Overcoming assimilation challenges when integrating study
data into central databases
09:40 Improving communication and information sharing to ● Achieving better communication between investigators and
boost trial outcomes and reduce time to market CDMs and the changing role of investigators
● Enhancing communication strategies overcome the challenges Dr Fraser Inglis, Consultant Physician, GlASGOW
of organisational size and trial complexity MEMORy ClINIC
● Developing internal processes to facilitate openness
and collaboration 12:40 Lunch
● Making sense of data and identifying trends in clinical trials
Achieving better outcomes by minimising errors in data
●
gathering and interpretation
ANAlySING ThE lATEST CDISC STANDARDS:
● Gathering quality data through enhanced collaboration BEST PRACTICE STRATEGIES FOR AChIEVING
between data managers, statisticians, monitors and clinical COMPlIANCE FAST
investigators 14:00 Afternoon keynote: Developments in CDISC standards
Albert Chau, head of Biometrics, ANTISOMA
and the roadmap for integration and implementation
10:10 Making sense of the EDC market – choosing the right ● The current state of CDISC standards and the developments
platform and technology to enhance data capture and to core submission standards affecting manufacturers
integration capabilities ● Timelines for integration and progress of key initiatives
● Assessing multiple EDC platforms and ensuring they are fit for including CDASH and CDISC HL7 messages
purpose ● Effective strategies for CDISC implementation
● Ensuring compatibility with CDISC standards and input/export ● Optimising data collection using CDISC to reduce timeframes
functionality for data management and analysis
● Choosing tools to suit trial needs and working with vendors on ● An overview of the CDASH data collection standard and how it
agreed deliverables from software maps to the SDTM
● Overcoming EDC problems in trials conducted in ● Status on CDISC electronic protocol standard and how it
locations lacking technology infrastructures and suitable might impact CDM and trial registry processes in the future
communications networks Niels Both, Member of CDISC e3c, EuROPEAN CDISC
Jody Spooner, Business Development Manager, CMED COORDINATING COMMITTEE
10:40 Morning refreshments
ENTERPRISE AND huMAN RESOuRCE PlANNING
DEVElOPING FuTuRE TRIAl ASSETS uSING ENhANCED FOR MORE COST EFFECTIVE DATA MANAGEMENT
DATA STORAGE AND ARChIVING STRATEGIES
14:30 Educating biometrics personnel on systems and
11:10 Case study: Efficient approaches to data warehousing processes in an evolving trial environment
and archiving – a manufacturer’s perspective ● Understanding different platforms and variations in data to
● Utilising a Clinical Data Repository to implement and increase the standard of observable results
streamline clinical data management processes ● The changing roles within biometrics as clinical data is more
● Streamlining processes and automations for loading external data widely collected, accessed and maintained
● Building structured compilation of project and substance ● Opportunities for innovative approaches to data management
databases using one source for data pooling, standardised and analysis
storage structures and functionalities for the creation and ● Staff training and development to increase retention and
archiving of documentation reduce recruitment costs
● Integrating a variety of other tools to enable processing based Francis kendall, head of Statistical Programming, ROChE
on one source of original, transformed and derived data

3. Programme Day one Programme Day two
15:00 Metadata-driven enterprise data management 08:30 Registration
● Architecture to help organizations proactively manage data 09:00 Opening remarks from the Chair
● A metadata driven approach to provide a technical lotta Sellen, Director Data Management hub, ASTRAZENECA
foundation for data integration
● Metadata reporting and analysis to facilitate data lineage 09:10 Roundtable morning sessions
and standardization Delegates will be able to attend three one-hour roundtable
● Implementation and metadata management in a statistical discussion groups from a selection of key topics. Each
computing environment session will be chaired by an industry expert who will
● Validating data flows and relationships while minimizing facilitate an exchange of opinions, essential experiences
manual reviews and learning related to a current aspect of data
Julia Zhang, Associate Director Standards and Architecture, management.
GENZyME
Roundtable 1
Functional outsourcing of CDM to partners in
15:30 Afternoon refreshments emerging markets
Quantifying the value of outsourcing in reducing data
management costs and explaining the requirements for
STRATEGIC OuTSOuRCING SOluTIONS TO dealing with partners in emerging countries
lesley Mathews, Strategic Sourcing Manager,
GENERATE lONG TERM SAVINGS BAyER SChERING PhARMA
16:30 Improving trial outcomes through better monitoring
Roundtable 2
and relationship management in outsourced data
management Is EDC still the default method for data capture?
Can EDC be seen as an enabling tool for data management
● Taking the right steps from choosing a partner to
or is it creating more problems than solutions?
establishing the criteria for a successful partnership
Dr. Johann Pröve Global head Data Management,
● Successfully managing data quality, investigator network
BAyER SChERING PhARMA
and the local trial environment
● Improving ongoing processes through monitoring data Roundtable 3
collection and management Data management systems and change management
● Developing relationships of trust with CROs – balancing processes to maximise the potential of electronic tools
ongoing supervision with a hands off approach Key considerations in determining the right data
● Final assessment of the sponsor – CRO relationship and management tools and strategies for training investigators
lessons learnt from successes and failures lotta Sellen, Director Data Management hub,
Dr Johann Pröve, Global head Data Management, ASTRAZENECA
BAyER SChERING PhARMA
Roundtable 4
Data warehousing for more effective data
management
FASTER ROuTES TO MARkET ThROuGh ThE Who keeps what information and for how long? Realising
the value and usefulness of data after a trial
uSE OF EhR Philip henrik Puls, Senior Project Manager, NNIT
16:30 using Electronic health Records (EhR) to support and Roundtable 5
enhance medical research The convergence in the roles of data managers and
● Technological advances and broad implementation of clinical investigators
EHRs to accelerate clinical research in a challenging drug Implications for data management responsibilities in
development environment future trials
● The fast evolving EHR landscape in Europe and the US and Wafaa Agoumi, European System Quality Manager,
what this means for manufacturers SANOFI AVENTIS
How to develop a platform for the appropriate use of EHR
●
data to facilitate medical research
Roundtable 6
● Understand impact areas for the pharmaceutical industry how to better leverage clinical data to drive efficiency
including clinical research, clinical trial execution, study and quality in clinical trials
Improving the clinical trials process through the strategic
feasibility, pharmacovigilance, personalised medicine and
use of trial data
outcome studies
Dr Beat Widler, Global head, Clinical Quality Assurance,
● Findings and recommendations from the EFPIA EHR task
ROChE
force for leveraging EHR utilisation on a broad scale
● Examples of opportunities and case studies aiming to 12:30 Lunch
improve patient safety aspects
● Overcoming issues in EHR interoperability including legal, IMPlEMENTING DATA STANDARDISATION FOR
technical, organisational, financial and political will lONG TERM EFFICIENCy GAINS
Mats Sundgren, Principle Scientist, ASTRAZENECA
13:40 Afternoon keynote: Achieving consistency in
CDISC implementation to make best use of data
17:00 Closing remarks from the Chair and close of Day One management resources
● The risk of diminishing the positive impact of standardisation
through variations in the interpretation of core standards
● Matching data standards to in house processes
● Eradicating variations across manufacturers in the
understanding and implementation of standards

4. Wednesday 18 November 2009
● Using EDC platforms and building in agreements with 16:40 Overcoming implementation challenges in the
vendors to streamline compliance with CDISC standards CDISC SAS Data Warehouse Project to improve the
● Adapting internal standards and adopting CDISC as the front submission process
end standard for data gathering ● CDISC SDTM conversion as part of a clinical data life cycle
Wolfgang Summa, Member of CDISC e3c, EuROPEAN CDISC ● Consistent handling of data across different sources
COORDINATING COMMITTEE (EDC, Paper, CRO and legacy systems) to improve
14:10 CDASh in data management - in search of the mapping processes
● Streamlining the CDISC mapping process by reusing
simplified process
programmes across studies to ensure more efficient
● Processes with CDASH - SDTM: who is responsible for what?
use of resources
● Implementing the CDASH data structure
● Faster pooling of data across studies and improving the
● Overcoming problems with EDC systems and CDMS
electronic submission capacity
● Presentation of a tool that helps solving these problems
Fritz Maritsch, Director Global Data Management, BAxTER
● Some other non-technical challenges during implementation
Stefan Beimel, Global Clinical Biometrics, Section head
Clinical Data Management, MERZ PhARMACEuTICAlS
DEVElOPMENTS IN ClINICAl DATA MANAGEMENT
14:40 Electronic document management solutions to store AND ThE FuTuRE lANDSCAPE FOR TRIAlS
and control clinical documents and implementation
of best practices for automating the trial master file 17:10 Professional developments in clinical data
● The role of an electronic Trial Master File in the Clinical management: the changing role of the data manager
Systems Architecture ● The focus for data management now and in the future
● ROI on implementing an electronic clinical documents ● Trends in technological developments that will impact CDM
management system ● Innovations and improving standards through
● Connecting the sites, the sponsor and the collaborators with continuous development
a clinical trial portal ● CDM interaction with monitoring and investigative sites for
● Integrating an electronic trial master file with a CTMS efficient study conduct
● Best practices and worst nightmares – lessons from the field Margarete Rudloff, DVMD Representative and Member,
ken lownie, Vice President of life Sciences, NExTDOCS INCDMA
15:10 Afternoon refreshments 17:40 Closing remarks from the Chair and close of conference
ThE BENEFITS OF STANDARDISATION – VIEWS AND
GuIDANCE FROM MANuFACTuRERS
15:40 Case study: Building a business case for
standardisation and embedding processes
● Lessons learnt from one of the first Italian CDISC
implementation projects
● Engaging all stakeholders to create buy-in for
standardisation
● Taking forward ideas to successfully embed core standards
in data management Who should attend?
● Managing the complex process of implementation to
maximise the benefits of standardisation
The audience will be made up of Vice Presidents,
Alessandro Antonellini, head of Statistics and Data Directors and Managers within pharmaceutical and
Management, RECORDATI biotech manufacturers from the following areas:
16:10 Case study: Standardisation as a route to more cost ● Data Management
effective data management ● Outsourcing
● Quantifying cost and efficiency savings to build a business
case for implementing CDISC ● Clinical Operations
● Engaging internal partners to create a consensus ● External Alliances
on standardisation and develop an action plan for
implementation ● Clinical Trials
● Measuring the financial and strategic advantages of ● Clinical Research
standardisation for CDM and optimising day to day processes
● Additional benefits of standardisation – improved ● R&D
information sharing and data integration ● Project Management
● Conforming to standards to harmonise data prior to
submissions and reducing the time to market ● Contracts
Silvana Cappi, Executive Director of Biometrics,
● Legal Counsel
FERRING PhARMACEuTICAlS
Register online now at: www.pharmadata-event.com

5. post-conference workshop Gold Sponsor:
NNIT is one of Denmark’s leading
CDISC Standards and Implementation consultancies in IT development,
implementation and operations. For over a decade, we have
thursday 19 november 2009 applied the latest advances in technology to make software
development, business processes and communication
Led by: Alessandro Antonellini, head of statistics
significantly more effective. We are owned by Novo Nordisk
and Data Management, recorDAti A/S, and with roots in the pharmaceutical industry we supply
services that meet the industry’s highest requirements for
About the workshop: quality and standardisation. www.nnit.com
The move towards standardisation in data management during
clinical trials is one of the biggest challenges facing manufacturers
and CROs today. CDISC standards have evolved over a number of Sponsors:
years and are set to shape the future of data management as the CMED is an eCRO, based in Europe and
industry moves towards a more consistent approach to managing the US. Founded in 1999 by experienced pharmaceutical
the vast amount of data generated during a trial. industry executives, Cmed is a unique combination of a
Implementing CDISC standards requires a thorough understanding
Clinical Research Organization and a technology development
of the processes involved and how to match these to in house company. The operational activities of Cmed's CRO division
practices to ensure that the complexities of standardisation are are underpinned by Timaeus, Cmed's technology. Timaeus is
managed effectively and the outcomes meet the guidance set out the world's most sophisticated and complete electronic data
in the range of standards. capture and management system. www.cmedresearch.com
This workshop provides a peer to peer interactive environment NextDocs is the leading provider of
to engage and discuss the challenges of implementation of core
regulatory document and quality
standards. It is intended to enable practitioners to share their
management software solutions
experiences with colleagues on how best to move forward in
based on SharePoint 2007. Our products are purpose-built for
making processes fit the CDISC model as the industry moves
rapidly towards a uniform approach to data management. businesses in highly regulated environments. By improving on
Microsoft's dynamic SharePoint platform, NextDocs document
management solutions are cost-effective, intuitive, flexible
Workshop agenda: and scalable. www.nextdocs.com
09:00 Registration
09:30 SESSION 1:
● Validating the CDISC Study Data Tabulation Model Exhibitors:
10:00 SESSION 2:
● Introduction to CDASH and compatibility with SDTM
10:30 SESSION 3:
● Standardisation as a route to ease the
submissions and approval process
11:00 Refreshments
11:20 SESSION 4: Co-sponsors:
● Development of the CDISC HL7 messages
11:50 SESSION 5:
● Technical Implementation Strategies in a CDISC
environment
12:20 SESSION 6:
● Operational Data Modelling Implementation
12:50 Close of workshop
Supporting Association:
Association for Clinical Data Management
About your workshop leader: We are a not-for-profit organisation that
Alessandro Antonellini is a statistician and data manager with represents and supports professionals
experience of drug development from phase I to IV in international involved with managing clinical data from within the
projects with several dossier submissions in US and Europe. Before pharmaceutical, biotechnology and academic research fields.
joining Recordati S.p.A. as Head of Statistics and Data Management www.acdm.org.uk
at the beginning of 2009, he worked in Switzerland for Helsinn
Healthcare SA. Recordati, established in 1926, is a European
pharmaceutical group, dedicated to the research, development,
manufacturing and marketing of pharmaceuticals, with headquarters
in Milan, Italy, operations in the main European countries, and a
Media Partners:
total staff of over 2,900. www.recordati.com
Dr. Zhang has worked in Pharmaceutical and Biotechnology
Industries for over13 years. She is an active member of HL7 and
CDISC standard organizations. Her expertise is in following areas:
• Regulatory submissions both in paper and electronic
• Development/implement industry standards (HL7, CDISC) for
submission, statistical analysis reporting and clinical trial data Do you wish to exhibit your products
collection
• Statistical analysis on clinical trial
and services at this exclusive event?
• Data management, such as clinical data collection, reviewing, If you want to be part of this leading industry event, please
cleaning, and exchange, etc.
• Clinical trial database design. Her broad clinical experiences cross contact Jaz Sidhu in our sponsorship team.
different therapeutic areas including infectious diseases, respiratory, Email: jazsidhu@VIBevents.com or call: +44 (0)20 7753 4259
oncology and rare inherited disorders.

6. Booking Form
The Evolution of Clinical Data Management, Tuesday 17 and Wednesday 18 November 2009, Munich, Germany
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