the evolution of clinical data management

The Evolution of Clinical Data Management USAImplementing CDISC standards and improving data management strategies to reduce the cost of drug development

Register online now at: www.arena-international.com/pharma/datamanagementusa/

Tuesday 23 and Wednesday 24 February 2010, Washington DC, USA

CONFERENCE HIGHlIGHTS:Outline strategic guidance and provide practical ★

advice on implementing CDISC standards with case studies from leading manufacturers

Discover proven ideas for reducing data ★

management costs in clinical trials and working effectively with global partners

Evaluate use of EDC tools for improving data ★

gathering and integration in onshore and offshore clinical trials

WORKSHOP HIGHlIGHTS: Peer-to-peer learning environment to develop improved strategies for implementing data standards

Solution led discussions on core standards and future developments

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

TOP COMPANIES INClUDE: GSK

Schering Plough

Merck

Wyeth

Human Genome Sciences

Vertex Pharmaceuticals

Allergan

Bristol-Myers Squibb

Ariad Pharmaceuticals

ImClone Systems

Boehringer Ingelheim

Eli Lilly

DISTINGUISHED SPEAKERS INClUDE:

Andy lawton, Head Clinical Data Management, BOEHRINGER INGElHEIM UK

Katherine Arbour, Director Clinical Data Management, ARIAD PHARMACEUTICAlS

Terry Katz, Vice President, Biostatistics and Data Management, IMClONE SYSTEMS

Julia Urbanchuk, Director, Organizational Development & Change, MERCK

Dante Covelli, Associate Director, Clinical Data Management, ElAN PHARMACEUTICAlS

Sharon Rittenhouse, Senior Manager, Clinical Data Management, AllERGAN

Susan Howard, Assistant Director for Oncology Data Management, GSK

Darlene Kalinowski, Associate Director, EDC Operations, BRISTOl-MYERS SqUIBB

Jane Diefenbach, Founder and Steering Committee Member DCDISC, CDISC(Pending final confirmation)

Organised by:

Program Day One Tuesday 23, February 2010

11:40 Improving trial outcomes through enhanced communication and collaborationDeveloping communication strategies to overcome the challenges ●

of organizational size and trial complexity Improving internal processes to facilitate openness and ●

collaborative workingMaking sense of the data and identifying the trends in clinical trials ●

Achieving better outcomes by minimizing errors in data gathering ●

and interpretationEnsuring best quality data through enhanced communication between ●

data managers, statisticians, monitors and clinical investigatorsSharon Rittenhouse, Senior Manager, Clinical Data Management, AllERGAN

12:10 Lunch

Sustainable outsourcing strategies for cost efficient data management

1:30 Getting best results from outsourced data management functionsStrategies for achieving cost effective data management in the ●

current economic climateManaging the opportunities and risks of different outsourcing options ●

Avoiding costly mistakes by choosing the right partner to fit the ●

needs of your trialPractical tools and techniques for selecting the right provider ●

– understanding the business case for outsourcing and vendor capabilitiesKeeping control through optimizing timelines and costs in the ●

data management processSpeaker TBC

2:00 Case Study: Hybrid CRO and sponsor partnerships to produce cost-effective outcomes for global EDC oncology trialsDetermining the participants and allocating responsibilities and ●

decision-making to eachUnderstanding the sites relationship with EDC and maximizing the ●

tool’s capabilitiesDetermining critical paths for EDC trials that are designed specifically ●

for large, global oncology trialsCost-effective models for CROs and Sponsors that manage data ●

collection for an EDC trial successfullyKatherine Arbour, Director, Clinical Data Management, ARIAD PHARMACEUTICAlS

2:30 Medical Dictionary for Regulatory Activities (MedDRA) to ensure ease of use for data entryBackground of who should subscribe to MedDRA – identifying the ●

benefits prior to trialPractical steps for facilitating retrieval, analysis and display to ●

achieve a suitable balance between sensitivity and specificity within the regulatory environmentApplying the release and use schedule of the latest version ●

developed by MedDRA Versioning Blue Ribbon Panel: the benefits for data managersAn overview of the changes to MedDRA v 12.0 and case studies ●

outlining the version impactJean Morrone, Manager, Clinical Data Management, VERTEx PHARMACEUTICAlS

3:00 Afternoon refreshments

3:30 Maximizing the potential of transformation through effective change management strategiesWhat differentiates successful transformation from failures? ●

Understanding the human capital side of change for more ●

productive resultsGoing beyond the processes and technology in embedding change ●

Developing a framework for effective change management to ●

reduce inefficienciesJulia Urbanchuk, Director, Organizational Development & Change, MERCK

08:30 Registration

09:00 Opening remarks from the ChairAndy lawton, Head Clinical Data Management, BOEHRINGER INGElHEIM UK

Streamlining data processes and reducing costs through the effective application of standards

09:10 Achieving standardisation to speed up clinical trials and reduce time to marketWhy standardise data management? - key drivers and recognising ●

long terms benefits for the clinical trials processThe data modeling process and the benefits of adopting CDISC ●

standardsIntegration and progress on key initiatives including CDASH and ●

CDISC HL7Reducing timeframes for data management and improving resource ●

allocationStatus on CDISC electronic protocol standard and the impact on CDM ●

and trial registry processes in the futureMelissa Binz, Director, Central Standards Group, WYETH(pending final confirmation)

09:40 Overcoming obstacles to standardization to create a streamlined, interoperable data collection processAssessing the CDASH data collection standard and how it maps to the ●

SDTMDealing with counter-intuitive naming conventions and problems for ●

SAS programmersOutlining practical implementation goals (CDASH-ODM) for better results ●

Facilitating interoperability between clinical systems including data ●

from Electronic Health Records (EHRs), numerous clinical data systems and trial sitesIdentifying when standards help and when they threaten productivity ●

Moving forward with uniform standards and building an improved ●

landscape for clinical data managementPierre Verroye, Executive Director, Clinical Data Management and Clinical Programming, HUMAN GENOME SCIENCES

10:10 Consistency in standards interpretation to reduce submission errorsKnowledge of evolving standards to ensure smooth submission ●

processes Coordinating in house processes to CDISC standards to ease ●

implementation Overcoming pitfalls in using EDC tools for front end data ●

standardization Successfully making the journey from case report form to CDISC ●

SDTM Case report from design considerations to ease the creation of CDISC ●

SDTM data sets Integrating data from multiple sources and managing regulatory ●

obstacles Scott Getzin, Data Scientist, ElI lIllY (pending final confirmation)

10:40 Morning refreshments

Improving resource allocation to enhance data reliability and trial outcomes

11:10 Increasing data reliability in a globalize trial environmentInnovative strategies for coordinating data management functions ●

across multiple international trial sites to achieve consistent reliable observations and outcomesDeciding upon the division of resources for maximum cost ●

effectivenessOutlining practical collaboration tools and techniques to keep the data ●

moving and prevent blockagesSolutions for monitoring, reporting and administering global trials ●

Dante Covelli, Associate Director, Clinical Data Management, ElAN PHARMACEUTICAlS

Program Day Two Wednesday 24, February 2010

Maximizing the use of EDC tools for simpler, cheaper and quicker data management

4:00 Getting from data capture to a ‘clean’ data setEstablishing a data plan to minimize data leakage and waste in transit ●

Taking the data from front end capture to integrated database ●

without compromising data integrityCollating data from eCRFs, ePRO and EDC platforms while ●

maintaining data safety and privacyPractical strategies to manage the problem of data sharing and ●

integration to cut time and cost during trialsThe use of data cleaning plans to provide a framework for ●

data integrationTerry Katz, Vice President, Biostatistics and Data Management, IMClONE SYSTEMS

4:30 How to realize the benefits of EDC in trials conducted in emerging countriesSuccessfully managing trial circumstances affecting operability ●

of EDC toolsOvercoming lack of technology infrastructures in clinical trials ●

in emerging countriesSolutions to communication problems in locations that cannot ●

support EDCBalancing overall trial costs with data capture and integration ●

considerationsIdentifying hidden costs of the trial environment - the impact ●

on data capture and integrationDarlene Kalinowski, Associate Director, EDC Operations, BRISTOl-MYERS SqUIBB

5:00 Closing remarks from the Chair and close of Day One

08:30 Registration

09:00 Opening remarks from the ChairCarol Buck, Assistant Director, Clinical Data Management, SCHERING PlOUGH

09:10 Roundtable morning sessionsDelegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of data management

Roundtable 1Balancing cost and trial outcomes in outsourcing data management in a global trial environmentQuantifying the value of outsourcing to reduce data management costs and building sustainable relationships with CROs Katherine Arbour, Director, Clinical Data Management, ARIAD PHARMACEUTICAlS

Roundtable 2Is EDC still the default method for data capture?Is EDC as an enabling tool for data management or creating more problems than solutions? Roundtable leader TBC

Roundtable 3Making data management systems and processes work for you to maximize the potential of electronic toolsKey considerations in determining the right data management tools and platforms for training investigators and incorporating collaborative visualization techniques into data analysis Robert Gordon, Manager, Biostatistics and Medical Pharmacovigilance, JOHNSON AND JOHNSON

Roundtable 4Data warehousing for more effective data managementWho 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 5The convergence in the roles of data managers and clinical investigatorsImplications for data management responsibilities in future trials Dante Covelli, Associate Director, Clinical Data Management, ElAN PHARMACEUTICAlS

Roundtable 6How to better leverage clinical data to drive efficiency and quality in clinical trialsThe use of clinical data to improve the clinical trials processTerry Katz, Vice President, Biostatistics and Data Management, IMClONE SYSTEMS

12:30 Lunch

Harnessing growth opportunities in a challenging trial environment1:40 Afternoon keynote: Increasing understanding of

CDISC standards to maximize benefits of a universal data management approachKey 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 ●

improve resource allocation during clinical trials Update on CDISC standards and how they fit with the goals of industry ●

and FDA - exploring Protocol, CDASH, SDTM and ADaM standards Implementing CDISC data standards: how do you know if you got it right? ●

Implications of the CDISC HL7 standard ●

Jane Diefenbach, Founder and Steering Committee Member of DCDISC, WASHINGTON DC CDISC IMPlEMENTATION NETWORK(pending final confirmation)

REGISTER ONLINE NOW!www.arena-international.com/pharma/datamanagementusa/

Program Day Two Wednesday 24, February 2010

2:10 Facilitating drug development through standardizationStandardization as a strategy to generate cost savings and shorten ●

development timelines Changing data processes to gain a competitive edge in a ●

difficult market: a cross-functional approach Accelerating the route to market through streamlined data ●

management and analysis: from CRF to data repository Carol McKenna, Associate Director, Clinical Data Management, Biogen IDEC

Reducing the time to market through the use of EHR2:40 Using Electronic Health Records (EHR) to enhance the

clinical trials processThe EHR landscape in the US and implementation goals to accelerate ●

clinical researchThe benefits and challenges of the secondary application of EHR data ●

in clinical researchDeveloping an understanding for the need of profile supporting for the ●

use of EHR systems in clinical researchAn integrated approach to the use of EDC tools to increase efficiency ●

at the point of patient contact in order to speed up the lengthy medicine development cycleOvercoming challenges in EHR interoperability from a legal, technical, ●

organizational, financial and political stand point. ‘Real world’ lessons learnt from connecting electronic healthcare and ●

research systemsSusan Howard, Assistant Director for Oncology Data Management, GSK

3:10 Afternoon refreshments

The future of drug development - a patient centred approach to new treatments3:40 Maximizing the benefits of collaborative visualization

(CV) from small to large trialsTechniques to take data review to the next level by identifying what ●

makes a good CV tool Building CV into processes to generate more cost-effective data ●

analysis solutions Using CV for early detection of problems ●

Knowing each person’s responsibilities and using data visualization ●

systems to facilitate team awareness and improve decision making Andy lawton, Head Clinical Data Management, BOEHRINGER INGElHEIM

Making the most of trends and changing roles in data management4:10 Improving the metrics and coding for

data managementAligning operational metrics with organizational goals for ●

measurable outcomesExchanging metrics between different groups and systems within ●

an organizationDeveloping applications to capture and analyze metrics across all ●

data management functions to reduce costsUsing tracking and metrics tools to monitor real-time data retrieval ●

Speeding up the process of observations and centralization of ●

data to reduce time lags in clinical trialsPierre Verroye, Executive Director, Clinical Data Management and Clinical Programming, HUMAN GENOME SCIENCES

4:40 Strategic changes to the role of data managers in an EDC environmentInterpreting the roles of clinical investigators, CRAs and clinical data ●

managers and the need to cooperateClarifying the responsibilities of professionals gathering and ●

interacting with dataEDC as a catalyst for convergence in data management functions and ●

understanding the impact on clinical trialsChallenges and solutions for managing multiple entry and access ●

points to maintain overall data reliabilitySpeaker TBC

5:10 End of day two and close of conference

Workshop agenda:09:00 Registration

09:30 An overview of CDISC CDASH standards - The relationship between CDASH and SDTM

10:00 SESSION 1:How to map from CDASH to SDTM ●

10:45 Refreshments

11:15 SESSION 2:How to map from CDASH to SDTM ●

12:00 SESSION 3:How to map sponsor CRFs to existing CDASH domains ●

12:45 Close of workshop

POST-cONFERENcE WORkShOP

Techniques and Strategies for Implementing CDISC CDASH StandardsThursday 25 February 2010 Led by: kit howard, MS, ccDM, Principal and Owner, kESTREL cONSuLTING and Dorothy Dorotheo, Director, clinical Data Management, INTERMuNE

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 of data generated during a trial. However developing an effective implementation strategy that incorporates in-house processes is a huge challenge.

Through a combination of lectures and hands-on exercises, this workshop will provide an interactive environment for you to discuss the various challenges of implementation. Attendees are encouraged to bring a sample Concomitant Medications CRF and the associated database structure in order to conduct a 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 CDASH model and speed up data submissions.

Students will receive:

1. Slide deck of the presentation materials

2. Tools for performing the mappings

Workshop learning objectives:

1. Understand the content of CDASH

2. Understand the data structure philosophies behind the standard

3. Learn how to map CDASH into SDTM, including each field existing in CDASH and not in SDTM

4. Learn how to map sponsor CRFs into CDASH with results that are both CDASH and SDTM conforming

About your workshop leader:Kit Howard has 25 years of experience in the industry, and extensive experience in the design, implementation and maintenance of cross-functional clinical data standards. She is a member of the CDASH Core management team, the CDISC Devices team, and the CDASH ODM development team, and is a long-term member of the Society for Clinical Data Management’s Editorial Board. She has spoken and published extensively on topics related to standards and data quality, and is passionate about the potential for standards to revolutionize the way we bring treatments to patients.

Kestrel was established in 2003, and specializes in clinical data standardization and clinical data quality. With a select network of consultants, Kestrel provides both consulting and educational services to the biopharma and medical devices industries, especially in the area of CDASH implementation. www.kestrelconsultants.comDorothy Dorotheo has over 27 years of clinical development experience including clinical and data management, project management, CRO outsourcing and oversight. She has extensive experience in spearheading the establishment of company standard data collection instruments through creation, implementation and maintenance.

Dorothy is a member the CDASH Core management team, leading one of the first CDASH domain streams, Prior and Concomitant Medication domain as well as the CDASH ODM development team. She is a certified clinical data manager (CCDM). Over the years, she has acquired additional training in clinical trial management, CDISC (SDTM & ODM), GCP, document management, project management, eCTD submission, communications and other clinical development related topics. Dorothy is a member of DIA and SCDM. www.intermune.com

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 [email protected]

About the ConferenceIn the current environment where reducing the cost of drug development is paramount, Arena-International’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 discussions from leading manufacturers, this conference will deliver time and cost saving methods for improving your data management processes.

Who should attendThe audience will be made up of Vice Presidents, Directors and Managers within pharmaceutical and biotech manufactures from the following areas:

Data Management ●

Outsourcing ●

Clinical Operations ●

External Alliances ●

Clinical Trials ●

Clinical Research ●

R&D ●

Project Management ●

Contracts ●

Legal Counsel ●

Media Partners:Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit our site to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. www.biocompare.com

Pharmaceutical Business Review: The Business Review websites are your number one stop for all the latest news, comment and industry information. Each Business Review website offers content that is produced by a dedicated team of 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 market research and industry analysis.

Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors every month. For further information contact [email protected]

Pharmaceutical Technology is used daily as a means of creating partnerships and as a point of reference by professionals within the pharmaceutical industry. This comprehensive resource supplies the latest news releases, detailed information on industry projects, white papers, event information and a thorough breakdown of products and services. www.pharmaceutical-technology.com

Supporting Association:ACDM - Association for Clinical Data Management: We are a not-for-profit organisation 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:

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the evolution of clinical data management

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