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The Evolution of Clinical Data Management
The Evolution of Clinical Data Management
The Evolution of Clinical Data Management
The Evolution of Clinical Data Management
The Evolution of Clinical Data Management
The Evolution of Clinical Data Management
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The Evolution of Clinical Data Management

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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 …

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.

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  • 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 Prices & Payment Information (please tick option) Four Easy Ways To Book: Before Before Before After ■ Register online at Yes, i would like to register for the event: December 1 December 29 January 26 January 26 www.arena-international.com/pharma/ Pharma and Biotech attendees datamanagementusa/ I would like the VIP attendees package to include the ■ Email us at two day conference + the post-conference workshop $3690 (VAT $3790 (VAT $3940 (VAT $4190 (VAT events@arena-international.com where applicable) where applicable) where applicable) where applicable) + interactive CD-ROM ■ Tel +44 (0)20 7753 4268 I would like to attend the two day conference + the post conference workshop (saving $100) $3090 $3190 $3340 $3590 ■ Fax +44 (0)20 7915 9773 I would like to attend the two day conference + $2895 $2995 $3145 $3395 Venue Details interactive CD ROM The two day conference will take place on Tuesday 23 I would like to attend the two day conference only $2295 $2395 $2545 $2795 and Wednesday 24 February 2010. The venue for all two days will be located in Washington D.C.. For further The post conference workshop $895 $995 $1145 $1395 information contact our Operations department on +44 (o) 207 753 4201. Fees for all other attendees (service providers + vendors) Are you registered? I would like to attend the two day conference $3295 $3395 $3545 $3795 You will always receive an acknowledgement of your booking. If you do not receive anything, please call us I would like to attend the two day conference + on +44 (0) 20 7753 4268 to make sure we have received $3895 (VAT $3995 (VAT $4145 (VAT $4395 (VAT your booking. interactive CD-ROM (saving $100) where applicable) where applicable) where applicable) where applicable) All total fees are subject to a 2.5% service charge I cannot attend the conference but would like to $700 (VAT $700 (VAT $700 (VAT $900 (VAT receive the interactive CD-ROM where applicable) where applicable) where applicable) where applicable) Discount code if applicable _________________________________ Total Discounts are at the discretion of Arena International and are not cumulative Arena International Conference Delegate terms and conditions 5 General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this 1 Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and Agreement (in whole or part) without our prior consent. 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