The document outlines the 2nd Annual Clinical Data Standardisation and Management conference, scheduled for June 6-8, 2011, at America Square Conference Centre, London. It highlights the importance of clinical data management strategies, featuring leading experts discussing clinical data standardisation, outsourcing, and regulatory submissions. Attendees are encouraged to register by April 29, 2011, to benefit from reduced fees and participate in interactive workshops aimed at enhancing cross-industry collaboration and best practices.

1. Register and pay before
29th April 2011 to save up to £300
Presents the 2nd Annual *terms apply
Clinical Data
Standardisation
and Management
Venue: America Square Conference Centre, London, UK Benchmark your strategies
www.clinicaldataevent.com
Main conference: 7th – 8th June 2011 with 16 leading experts
Pre-Conference: 6th June 2011 from the realm of clinical
data management:
Developing optimum strategies for improving Phillippe Verplancke, CDISC E3C
clinical data management through CDISC Member
standardisation, best-practice outsourcing, data Peter Van Reusel, CDISC E3C
Member and Business Unit
warehousing and legacy data transformation Director of CRO Services,
Business & Decision
Our panel of experts will help you to:
Herbert Noack, Vice Chair,
w Understand the latest CDISC initiatives and how their CDISC E3C Member & Project
applications can benefit you in the clinical data world: three Statistician – Medical Affairs,
CDISC E3C members give their insights Boehringer Ingelheim
Andrew Miller, Director of
w Discover and apply the best-practice approach to outsourcing Clinical Data Standards,
clinical data to CROs: Bristol-Myers Squibb and Nycomed AstraZeneca
present their evidence Sue Dubman, Senior Director,
w Optimise performance through end-to-end CDISC alignment in Standards and Architecture,
your business: AstraZeneca, Genzyme and Antisoma share their Genzyme
experience Kjell Pennert, Head of Research
Data Management and Statistics
w Fast-track regulatory submissions using CDISC standards: LEO Unit, The Royal Marsden NHS
Pharma show you how Foundation Trust
w Setup and maintain metadata repositories to better govern your Albert Chau, Head of Biometrics,
clinical data: CDISC, Roche and Eli Lilly give you their examples Antisoma
w Plan your company’s journey through data standardisation with Chris Price, Senior Technical
illustrative case studies from Roche and Merck amongst others Programmer, Roche
Berthold Traub, Associate
Director, Nycomed GmbH
Advisory Board
Peter Van Reusel, CDISC E3C Member Albert Chau, Head of Biometrics, Paul Vervuren, Head Scientific
and Business Unit Director of CRO Antisoma Programming Women’s Health &
Services, Business & Decision Endocrine, MSD
Francis Kendall, Head of Programming,
Andrew Miller, Director of Clinical Data Roche Francis Kendall, Head of
Standards, AstraZeneca Programming, Roche
Yiannis Karageorgos, Senior
Pre-conference Workshop Day: Top highlights you can’t afford to Protocol Data Manager, Bristol-
6th June 2011 miss: Myers Squibb
Take the time to discuss and share 4 Three members of CDISC E3C discuss Bruce Basson, Statistician, Eli Lilly
ideas with leading experts in your the current state of play with regards Zoe Williams, Clinical Biometrics
field in two interactive workshop to cross-industry data standardisation Manager, LEO Pharma
mini-courses: Julie James, HL7 Board Member
4 Four interactive discussions with
A) CDISC Implementation experts in the data management field & Partner, Bluewave Informatics
Workshop Hugh Glover, HL7 Board Member
4 Gain an in-depth understanding of the
& Partner, Bluewave Informatics
B) Integration and Interoperability: issues involved in data warehousing,
Getting To Grips With HL7 legacy data transformation and end to
end, CDISC alignment “Good to meet the main
players and have made contacts
that I would not have made
otherwise.”
Medimmune
Tel: +44 (0)20 7368 9300 Email: enquire@iqpc.co.uk Web: www.clinicaldataevent.com

2. Conference Day One: 7th June 2011
08.30 Coffee and Registration w Focusing on oversight of SAS programming as a critical process feature
w Exploring how to implement in-house quality control and quality
09.00 Chair’s Opening Remarks and Pharma IQ Welcome standards for maximal process surveillance
Albert Chau, Head of Biometrics, Antisoma
w Understanding the crucial nature of “review” – oversight vs.
09.10 Ice Breaking Session working together
A great opportunity to meet your peers who you will be interacting Berthold Traub, Associate Director, Nycomed GmbH
with and learning from over the next two days. Take the chance to
14:40 Thinking Outside the Box - Discussion Session
say what you’re looking to gain out of the event and what you’re looking
This is where we throw the format out the window and open the
forward to. At the end of this session, delegates will be encouraged to
floor to you. In this 40 minute session, our panel will choose
anonymously submit questions and topics of conversation into a
questions at random from the submissions box. Discussion and
suggestions box for the Thinking Out of the Box discussion session.
debate will ensue – thinking outside of the box is encouraged.
KEYNOTE SESSION: CDISC UPDATE 2011 15:10 Networking Coffee Break
09.20 The Future Of CDISC Standards Development Driven By
The SHARE Project PHARMA FOCUS: HL7 and Standardisation
w What CDISC SHARE will bring to the clinical data management fold 15:40 Integration And Interoperability: HL7 In The Realm Of
w Showcasing the status and time plan of the project thus far Pharma/Bio Focus
w Learning how to fill the metadata repository with therapeutic area w Introducing HL7: defining healthcare information in a
standards semantically robust way
w Understanding the CDISC governance process w The use of these standards by regulators: clinical trials reporting
w Using a CDISC-based metadata repository to drive each activity and results (CTRR) and identification of medicines (IDMP) and ICSR
within the clinical data management chain w Capitalising on the investment in conforming to these new
w Starting today: the re-use of metadata from define.xml for CRF design standards allows companies to learn to use the principles of HL7
Phillippe Verplancke, CDISC E3C Member and semantic interoperability for a much wider set of applications
than just those “required” by the regulators
Implementing CDISC Standards In Large And Small Pharma Companies w Leveraging the opportunity of interoperability with EHR
10.00 Implementation Of CDISC Standards In A Small Oncology- information - for EDC and for wider research
Focused Company With Data Management Outsourced w Maximising the return on the existing portfolio of medicines
w How a semi-virtual biotechnology company has implemented requires maximum information, basing that information on HL7
CDISC standards over the past few years will make it easier to get the information out without excessive
w Challenges and benefits on the implementation of CDISC standards analysis costs
in a small company Julie James, HL7 Board Member & Partner, Bluewave Informatics
w Processes that have been put in place to ensure a consistent Hugh Glover, HL7 Board Member & Partner, Bluewave Informatics
approach in an outsourcing model
w Considerations and challenges in implementing CDISC standards in The Best-Practice Case In The Offshoring Of Statistical Programming
a cancer trial setting 16:20 CASE STUDY: Important Points To Consider When
w Considerations in mapping legacy data into a CDISC-compliant structure Offshoring Statistical Programming: Experience Based
w The benefits of CDISC standards in promoting and improving data On Offshoring At Pfizer, Novartis And Roche
quality and efficiency in data review w Assessing the position that offshoring is essential to gain access to
Albert Chau, Head of Biometrics, Antisoma a wider talent pool
w Appreciating the pros and cons of offshoring: potential cost savings
10.40 Networking Coffee Break vs. oversight, training etc.
11.10 The Astrazeneca Journey To CDISC Implementation w Exploring the best offshoring model for your business – captive,
w Overview of the Astrazeneca standards governance model semi captive and full CRO models
w Tactical versus strategic implementation of CDISC standards w Understanding that an offshored workload has to be truly
w CDISC standards – complimentary or a replacement for existing transactional to obviate large hidden costs
standards? w Appreciating that offshored tasks should best be low to medium
w Governance and version control of CDISC standards within AstraZeneca complexity in nature to avoid confusion
w Lessons learnt w Ensuring that offshore sponsors allow for a high turnover rate in
w Future plans for CDISC implementation India and understand the consequent impacts on training plans and
Andrew Miller, Director of Clinical Data Standards, AstraZeneca what work can be offshored
w Keeping an eye on the economic variables: inflation, turnover and
Outsourcing: Keeping Things Out Of Your Control Under Control productivity
11.50 CASE STUDY: On the Path To Optimising The Sponsor w Considering the case for automation of transactional activities
CRO Relationship rather than offshoring
w Assessing the factors that influence pharmaceutical research Francis Kendall, Head of Programming, Roche
sponsors in their selection and retention of contract research
vendors and partners Pharma Focus: Data Managers in the Spotlight
w Exploring the full project to the full function/task outsourcing continuum 17.00 On The Evolving Role Of The Data Manager In The
w Understanding the type of sponsor project manager would serve Pharma/Biotech/Healthcare Industries
each outsourcing “style” best? w Showcasing how the introduction of technology has changed the
w Data flow vs. data quality reports: examining score-cards, landscape of data management in the last 10 years
performance evaluators and due diligence w Focusing on how standardisation of formats and process across
w Specialised procedures, central readers/adjudication committees, the industry will prompt even more pronounced changes in the
central laboratory and whether it is project or functional outsourcing? clinical data manager’s role
w Appreciating the crucial need for standardising template contract w Examining how the introduction and integration of e-sources has
agreements and benchmarking partners vs. in-sourced activities and will further promote a shift from processes centred on
Yiannis Karageorgos, Senior Protocol Data Manager, Bristol-Myers Squibb cleaning data to a focus on managing data flow
w Exploring the move towards the provision of real-time data to the
12:30 Lunch different stakeholders of a clinical trial
14:00 CASE STUDY: Nycomed’s Experience On How To Run An w Understanding how the clinical data manager’s role will be defined
Extreme Outsourcing Model in an automated e-future
w Introducing the clinical trial team setup and framework at Nycomed Kjell Pennert, Head of Research Data Management and Statistics
w Examining how to construct and implement a data integration plan Unit, The Royal Marsden NHS Foundation Trust
as the basis of all CRO-led standardisation
17.40 Closing Remarks From The Chair And End Of Day One
w Agreeing on SOPs with respect to quality for a well defined process
Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk

3. Conference Day Two: 8th June 2011
08.30 Coffee And Registration C Towards A Unified Approach For Standardising Legacy Data
09.00 Chair’s Opening Remarks and Pharma IQ Welcome Moderator: Peter Van Reusel, CDISC E3C Member and Business
Unit Director of CRO Services, Business & Decision
Andrew Miller, Director of Clinical Data Standards, AstraZeneca
D The Role Of The Data Manager: A Dying Or Evolving Breed
CDISC UPDATE Kjell Pennert, Head of Research Data Management and Statistics
09.10 CDISC-ADaM And The Concept Of “One Proc-Step Away” Unit, The Royal Marsden NHS Foundation Trust
w Understanding that different philosophies with respect to analysis 12.40 Lunch
datasets still exist
w Exploring what is optimal for the statistical and clinical reviewer at Examining CDISC And Regulatory Compliance
the FDA 14.00 Showcasing Metadata Repositories As A Focus
w Examining the CDISC-ADaM standard: going from cookbook to Of Pharma/Biotech Companies
therapeutic area needs w Comparison of different approaches to achieving data in CDISC
w Unraveling “one proc-step away” as defined in the statistical format for submission
analysis plan w Feedback on experience of submitting test data to the FDA
w Assessing derivations and traceability in the CDISC-ADaM structure w Considerations for the documentation that accompanies the data
w How to be prepared for the questions that will always be asked of you Zoe Williams, Clinical Biometrics Manager, LEO Pharma
Herbert Noack, Vice Chair CDISC E3C & Project Statistician – Showcasing Metadata Repositories as a Focus
Medical Affairs, Boehringer Ingelheim of Pharma/Biotech Companies
The Alpha And The Omega – End To End CDISC Alignment 14.40 CASE STUDY: Getting the most out of CDASH and SDTM:
09.50 CASE STUDY: Implementing Standards End-To-End On A automating the specification and validation process
Global Scale: The Genzyme Experience w Understanding how and why upfront implementation of the data
w Introduction to Genzyme’s GetSMART initiative, a Strategic, standards in your data management and statistical environment is
Measurable, Achievable, Realistic and Time-based program, to beneficial
implement global w Utilising data standardisation to better enable the automation of the
w Achieving the GetSMART Vision through structured content exchange of specifications and instructions to internal and external
management, data collection and processing, analysis and partners
reporting, core infrastructure and standards governance w Implementing a central data standards library and metadata
w Realising the benefits of upstream CDISC standardisation in repository to generate study specifications and verify study data and
providing measureable downstream benefits for products utilising metadata against the specifications and the data model
defined standard CDASH CRFs and SDTM implementations Peter Van Reusel, CDISC E3C Member and Business Unit Director of
w Understanding how to mature standards implementation through CRO Services, Business & Decision
on-going activities classified into three categories: standards 15.10 Networking Coffee Break
development, standards governance and technology-enabling
Sue Dubman, Senior Director, Standards and Architecture, Genzyme 15.40 CASE STUDY: Standardisation Of SDTM Mappings At Roche
w Assessing experiences of creating a new set of standards in a large
10.30 Networking Coffee Break pharmaceutical environment and what processes were followed
Data Warehousing And CDISC: The Cost/Benefit Analysis w Exploring a number of specific examples of where data collection/
11.00 Presenting The Business Case For Standardised Clinical protocol requirements led to challenges in mapping to SDTM and
Data Within A Pharma Company implemented solutions
w The challenges of standardising clinical data for statistical analysis w Analysing possible options to best handle change management
w Considerations for modelling a clinical data warehouse w Examining the challenges involved in implementation of change
w Project management aspects of standardising analysis datasets for management and lessons learned
multiple studies Chris Price, Senior Technical Programmer, Roche
w The role of CDISC standards in clinical data standardisation and warehousing 16.20 CASE STUDY: Eli Lilly’s Adoption Of The Operational
Paul Vervuren, Head Scientific Programming Women’s Health & Data Model
Endocrine, MSD w Exploring the rationale for adopting ODM
Roundtable Discussions w Understanding the challenges involved in customisation (including
11.40 Participants will be able to choose 1 of the 4 different some ODM gaps)
w Making a proprietary ODM library SDTM-friendly
roundtables and spend an hour dis cussing one of the
w What Eli Lilly has gained from converting to ODM
topics outlined below:
w Why Eli Lilly made the ODM library an Open Source resource
A The Open Source Future of CDM? w Casting a critical eye to the future: extending into a study design model
Bruce Basson, Statistician, Eli Lilly Bruce Basson, Statistician, Eli Lilly
B Functional Vs. Full Outsourcing - Evaluating The Best
Approach For Your Company 17.00 Closing Remarks from the Chair and End of Conference
Berthold Traub, Associate Director, Nycomed GmbH
Pre-Conference Workshop Day: 6th June 2011
A) 10.00-13.30 B) 13.45 – 18.00
CDISC Workshop – Introduction, Implementation and Integration and Interoperability: HL7 Workshop
Future Developments In this interactive workshop session HL7 board members Hugh Glover
Peter Van Reusel, the only registered CDISC SDTM trainer in Europe, and Julie James from Bluewave Informatics will take us through
member of CDISC E3C, CDISC SDTM team member and Business Unit a masterclass in the meaning and applications of HL7 standards in the
Director of CRO Services at Business and Decision, will facilitate an pharma/biotech/healthcare sectors. In this 4¼ hour mini-course areas of
interactive workshop concentrating on the implementation of CDISC standards concern will include the following:
in your processes. Areas covered in this 3½ hour mini-course will include: w Semantic interoperability/semantic robustness – this will be explained in
w CDISC introduction, CDISC implementation strategies and CDISC future some detail and contrasted to syntactic interoperability
developments 45’ w What is HL7? Participants will be given an overview of the principles of
w A data conversion methodology demo (using SAS Data Integration Studio) 45’ HL7 as a standard for achieving semantic interoperability
w An SDTM validation demonstration 30’ q Analysis principles
w What’s new in 3.1.2: the highlights 30’ q Information modelling including use of ISO datatypes and controlled
w Implementing CDASH and SDTM in Oracle Clinical / Remote Data Capture 45’ vocabularies
q Dynamic modelling and architectural principles
w Reading the standards - a look at the various materials and resources,
focussing on the domains of immediate relevance to the Pharma industry
- CTRR, ICSR, IDMP, RPS, e-Stability, SPL and particularly those currently
being specified by the regulators
w How should HL7 be adopted? A look at some of the practical issues
involved in getting started and some principles on how to capitalise on
the investment made (and some pitfalls to avoid)
Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk

4. Maximise Your Involvement: Sponsorship and Exhibition Opportunities
The 2nd Annual Clinical Data Standardisation & Management marketing solutions targeted at industry officials and executives
event will be attended by senior figures and decision-makers from and specifically tailored networking opportunities. Other features
industry, bringing buyers and suppliers together in one location. of sponsorship include:
On-message and on target, the event will provide an excellent
• Prominent exhibition space in the main conference networking area
platform from which to launch new business relationships.
• Participation in comprehensive pre-event marketing campaigns
With our tailored networking sessions, sponsors can achieve the • Tailored marketing strategies to suit your organisation’s size,
kind of face-to-face contact that overcrowded trade shows cannot. scope and individual requirement
Exhibiting and sponsorship options are extensive and bespoke For more information and to discuss the right opportunity,
packages can be developed to suit your individual company’s contact Diane McKenna on +44 (0)207 368 9300 or
needs. Most packages include complimentary entry passes, sponsorship@iqpc.co.uk
About pharma IQ
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Who should attend:
Directors, Heads and Managers involved in clinical data management. Functions include:
r Clinical Data r Informatics
r Information Management r Clinical IT
Last year’s attendees came from throughout Europe
y Denmark: 26%
y UK: 22%
y Switzerland: 17%
y Belgium: 5%
y France: 5%
y Germany: 5%
y Kuwait: 5%
y Spain: 5%
y Sweden: 5%
y The Netherlands: 5%
Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk

5. Clinical Data Standardisation 5 WAYS TO REGISTER
and Management 2011 Freephone: 0800 652 2363 or
VENUE: America Square Conference Centre, London, UK +44 (0)20 7368 9300
MAIN CONFERENCE: 7th – 8th June 2011
PRE-CONFERENCE WORkshOPs: 6th June 2011
Fax: +44 (0)20 7368 9301
To speed registration, please provide the priority code located on the mailing label or in the box below. Post: your booking form to
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