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2nd Annual

 The Evolution
 of Clinical Data
 Meeting the challenges of data integration and
 standardisation ...
Programme Day one                                                     Tuesday 17 November 2009

08:30 Registration        ...
Programme Day one Programme Day two
 15:00 Metadata-driven enterprise data management                      08:30 Registrat...
Wednesday 18 November 2009

   ●   Using EDC platforms and building in agreements with            16:40 Overcoming impleme...
post-conference workshop                                                      Gold Sponsor:
Booking Form
       The Evolution of Clinical Data Management, Tuesday 17 and Wednesday 18 November 2009, Munich, Germany
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The Evolution of Clinical Data Management


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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.

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The Evolution of Clinical Data Management

  1. 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:
  2. 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. 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. 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:
  5. 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. 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. 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. 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 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. 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: or call: +44 (0)20 7753 4259 oncology and rare inherited disorders.
  6. 6. 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