European Clinical Research Conference • European eClinical ...

OVERVIEWThe clinical trials process is undergoing a technology revolution. Our roles in support of clinical trials, be it investigator, study manager, monitor or data manager, are changing. Is technology driving the practice or do new clinical processes sufficiently influence the development andadoption of electronic solutions?

This conference will address this key question by providing a unique forum that brings all clinical development professionals together. The Multi-track format of this event will facilitate refreshing debate throughout the clinical trial lifecycle from the Investigator Site to database closure. We welcome your support.

LEARNING OBJECTIVES - At the conclusion of this programme, participants should be able to:

• Discuss the impact of new technology solutions for clinical research development on traditional roles and processes• Describe the benefits that clinical researchers derive from new technologies such as ePRO and EDC• Summarise the current status of standards, their implementation and adoption in the world of clinical data exchange

• European Clinical Research Conference • European eClinical Conference• 16th Annual European Clinical Data Management Conference

NOVEMBER 5-8, 2006 | CONGRESS CENTER, BASEL, SWITZERLAND

TARGET AUDIENCE

EXPERTISE AREA• Clinical Development • Clinical Project Management• Clinical Research• Data Management• Technology Applications and Solution Providers

ORGANISATIONAL POINT OF VIEW• Academic Research Organisations• Clinical Study Centres• Consultants, Experts and Support Organisations• Contract Research Organisations• Drug Regulatory Authorities and other Governmental Bodies• Pharmaceutical and Biotechnology Companies• Software Systems and Service Providers

JOB PROFILE• Biostatisticians and Statistical Programmers• Clinical Data Managers and Database Administrators• Clinical Data Standards Administrators• Clinical Investigators, Study Co-ordinators and Nurses• Clinical Operations - Monitors, Co-ordinators• Clinical Study/Project Managers • IT Professionals

THIS PROGRAMME WAS DEVELOPED BY THE CLINICAL DATA MANAGEMENT, E-CLINICAL AND CLINICAL RESEARCH SPECIAL INTEREST AREA COMMUNITIES

CLINICAL

Research

DataManagement

e The Changing Worldof Clinical Trials

The Drug Information Association (DIA) has been reviewed andapproved as an Authorized Provider by the International Associationfor Continuing Education and Training (IACET), 1620 I Street, NW,Suite 615, Washington, DC 20006.

The DIA has awarded up to 1.1 continuing education units (CEUs) to participantswho successfully complete this program and tutorials (each offers 0.3 CEUs)

If you would like to receive a statement of credit, please visit www.diahome.org.Detailed instructions on how to complete your credit request and download yourcertificate will be provided onsite.

Disclosure Policy: It is Drug Information Association policy that all faculty partici-pating in continuing education activities must disclose to the program audience (1)any real or apparent conflict(s) of interest related to the content of their presenta-tion and (2) discussions of unlabeled or unapproved uses of drugs or medicaldevices. Faculty disclosure will be included in the course materials.

Gilbert Bellachen, (CDM)Oracle Corporation, France

Rodica Badescu (Clinical Research)Romanian Drug Agency, Romania

Joris Cauquil (CDM)AMITIS/Effi-Stat-DMB Chairman, France(INCDMA Representative)

Franziska Falk (Clinical Research)Astellas Pharma GmbH, Germany

Eva Hammarstrom-Wickens, (eClinical)Orion Pharma R&D, UK (INCDMA Representative)

Emil Hristov (Clinical Research)Bulgarian Drug Agency, Bulgaria

Stéphane Marzabal (eClinical)Serono International, Switzerland

Sébastien Pourchaire (eClinical)BlueLinea, France

Barbara Veverka (Clinical Research)PharmaNet Services, GmbH, Switzerland

Pieter Voermans (CDM)F. Hoffmann-La Roche AG, Switzerland

Barry Burnstead (CDM)i3 Statprobe, UK

Stuart Cummings (CDM)Consultant, Belgium

Rebecca D. Kush (eClinical)CDISC, USA

Jeffrey W. Sherman (Clinical Research)NeoPharm, Inc., USA

Peter Stokman (CDM)NV Organon, The Netherlands

Valdo Arnera (eClinical)PHT Corporation, Switzerland

Jens Reinhold (CDM)Schering AG, Germany

Milen Vrabevski (Clinical Research)Comac Medical Ltd., Bulgaria

PROGRAMME CO-CHAIRPERSONS

PROGRAMME ADVISORS

PROGRAMME COMMITTEE

““TThhee CChhaannggiinngg WWoorrlldd ooff CClliinniiccaall TTrriiaallss””

Our annual multi-track conference welcomes this year for the first time, the participation of our colleagues fromClinical Research.

We all share a common interest in the way new technologies are influencing clinical operations. The era of “eClinical”has been heralded with promises around rapid data collection whilst raising quality by validating these data near to timeof collection. This will be delivered by the use of the internet accompanied by new data acquisition tools. However, arethe realities different? New technology requires everyone engaged in clinical research, from the investigator to the mon-itor and finally to the clinical data manager to re-assess their operations. Furthermore, we should not forget the patientand how they respond to the electronic gadgetry that is replacing the paper patient diaries. Existing procedures appliedto new tools can create friction and disappointment by not delivering the anticipated benefits.

Ultimately we ask the question “Is technology driving the Science?”

This conference offers a unique opportunity for everyone engaged in the execution of clinical studies to meet andexchange experiences and expectations. We need to build a greater collective understanding of how to embrace newtechnology and what we need to do to fully accommodate change. Whether it is in the redefinition of processes, reor-ganisation of departments, provision of training or adopting a new mindset, we are faced with fundamental changesto the way we work. This event will provide an insight into new ways of working and help prepare us all to enthuseover “The Changing World of Clinical Trials”.

Drug Information Association | www.diahome.org | 2

Conference at a Glance

13:00 Tutorial Registration


09:00-12:30 Parallel Tutorials (optional)

12:30-14.00 Lunch for Tutorial Participants & Conference Registration

14:00-15:30

15:30-16:00 Coffee Break in the Exhibition Area

16:00-17:30

17:30-18:30 Networking Reception in the Exhibition Area

Parallel Tracks

Sunday, November 5, 2006

FDA - CDISCeCTD Regulatory Submissions

Creating and Using a Business Architecture to SupportProcess, People and Technology

Clinical Operations Role in Achieving RegulatoryCompliance when Deploying eSolutions in Clinical Trials

Parallel Tutorial 2 Parallel Tutorial 3 Parallel Tutorial 4

Tuesday, November 7, 2005

Parallel Track 1:Clinical Research

Parallel Track 2:eClinical

Parallel Track 3:Clinical Data Management

The Changing World of Clinical Trials

Our Regulatory Framework - For Better or For Worse?

Opening Plenary Part 1

Opening Plenary Part 2

Session 1Regulatory Realities

Session 2Clinical Perspectives on Global

EDC Strategies

Session 2ePRO

Session 2Process Improvement

Coffee Break in the Exhibition Area

Session 1Practical Experiences with EDC

Session 1Coding

09:00-10:30

11:00-12:30

Session 6Practicalities of Managing EDC Studies

Session 6Data Standards - Technical Perspectives

11:00-12:30

Session 3Site Perspectives on New Technologies

Session 3Role of People in eClinical

Session 3Metrics

14:00-15:30

Session 4Geographic Contrast in Managing

Global Trials

Session 4Technology for Tomorrow?

Session 4Quality Fit for Purpose

16:00-17:30

10:30-11:00

Coffee Break in the Exhibition Area10:30-11:00

Lunch Break in the Exhibition Area12:30-14:00

14:00-17:30

Closing PlenaryIs Technology Driving Science?

14:00-15:45

Lunch Break in the Exhibition Area12:30-14:00

End of Conference15:45

Coffee Break in the Exhibition Area15:30-16:00

Wednesday, November 8, 2005

Parallel Track 1:Clinical Research

Parallel Track 2:eClinical

Parallel Track 3:Clinical Data Management

Session 5Improving Clinical Trial Processes

Session 5FDA - CDISC Interactions

09:00-10:30

Parallel Tracks

Tutorial 1 (optional) - Health Level Seven (HL7) and the Link to the Biopharmaceutical Industry

Monday, November 6, 2006

17:30-18:30 Networking Reception in the Exhibition Area


Health Level Seven (HL7) and the Link to the Biopharmaceutical Industry Tutorial 1

Instructor:

Pierre-Yves Lastic, Sanofi-Aventis, Germany

Health Level Seven (HL7) is seen as the world’s leading standard for the electronic interchange of healthcare information.CDISC and HL7 formed the Clinical Trials Special Interest Group, which became the Regulated Clinical Research Information Management (RCRIM)Technical Committee. The mission of this committee states: “This committee supports the HL7 mission to create and promote its standards by developingstandards to improve or enhance information management during research and regulatory evaluation of the safety and efficacy of therapeutic productsor procedures worldwide”.

This tutorial will provide a) an introduction to the processes of Health Level Seven (HL7) to develop, ballot and obtain accreditation for standards throughANSI and ISO, b) an introduction to the work of the RCRIM Technical Committee and c) an overview of the HL7 Development Framework, exemplified bythe BRIDG model

Learning Objectives - at the conclusion of this tutorial, participants should be able to:1. Summarise Health Level Seven (HL7)2. Discuss the HL7 Development Framework as it relates to the BRIDG model3. Describe the work of the RCRIM Technical Committee

FDA – CDISC: eCTD Regulatory Submissions Parallel Tutorial 2

Co-Instructors:

Frank Newby, CDISC, USASteve Wilson, FDA, USA

FDA issued a draft guidance in November 2003 that proposed how the Electronic Common Technical Document or eCTD would be submitted to theagency. In 2004, the draft guidance was updated to include the CDISC Study Data Tabulation Model or SDTM. The draft guidance was again updated in2005 to include the CDISC define .xml specification. The FDA made the draft guidance a "final" guidance on April 19, 2006.

This tutorial will provide background on SDTM-based eCTD as to the purpose for the development of the final guidance. Additionally, the processes thatsubmitting companies should undertake to help insure a technically successful submission when including SDTM-based data will be discussed as well aswhat the FDA does with that data once accepted.

Learning Objectives - at the conclusion of this tutorial, participants should be able to:1. Discuss the reasoning behind the FDA development of the eCTD guidance2. Identify the structural components of the eCTD3. Describe the process steps to ensure a technically successful SDTM submission as part of your eCTD including how to contact the FDA and when4. Explain what the FDA actually does with an eCTD submission with the focus on what is done with the data submitted in SDTM format5. Discuss what's next for the eCTD guidance

09:00-12:30 PARALLEL TUTORIALS (optional)



SUNDAY, NOVEMBER 5, 2006

MONDAY, NOVEMBER 6, 2006 - PARALLEL TUTORIALS Note: These Tutorials are in parallel

14:00-17:30 Tutorial 1 (optional)

Creating and Using a Business Architecture to Support Process, People and Technology Parallel Tutorial 3

Instructor:

John Aggerholm, Novo Nordisk IT A/S, Denmark

Today Pharma companies invest in people development, technology support and process optimization. Obviously, optimal integration of these initiatives,as well as with company strategies and the surrounding world are prerequisites for success. However, many struggle because it is hard to find the method-ology and the tools to create the overall picture, display the links and make optimal use of the new possibilities for change management and businessdevelopment, including outsourcing. This tutorial provides the theoretical insight and tools, followed by practical examples of how it has been implement-ed and used.

Learning Objectives - at the conclusion of this tutorial, participants should be able to:1. Describe the connections between processes, people and the technology used in defining business architecture. 2. Use the basic tools to document and use the sections in a business architecture – process overview, people skills/roles and the supporting IT

application architecture.

Target Audience:Advanced topic area. Anyone who is involved in the implementation of new technologies or business development and who wants to be able to ana-lyze and optimize critical processes.


Session Chairperson:

Barry Burnstead, i3 Statprobe, UK

The European regulatory framework influences the clinical developmentstrategy, processes and the technology we employ. It is vitally importantfor industry to be aware of the Regulatory Agencies’ current thinking onthe impact and realities of the CT Directive. This session will provide botha “central” perspective and the viewpoint of an Eastern Europeanagency, preparing for EU membership. Controversy may arise from anassessment of the industry’s perspective on regulations and how clinicalresearch is being influenced - for better or for worse?

Update on Clinical Trials - EMEA PerspectiveFergus Sweeney, EMEA, EU

Regulatory Challenges Confronting Romania - an Accession Country’s Agency ViewpointAntoniu David, Romanian Drug Agency, Romania

Our Regulatory Framework - Industry PerspectiveIngrid Klingmann, Pharmaplex, Belgium

Session Chairperson:

Jens Reinhold, Schering AG, Germany

Clinical development today is facing numerous challenges for everybodyinvolved. The magic word is always “change” which results from manychallenges in finding the right drug candidate, developing it quickly andmost efficiently, fulfilling new regulatory and data protection require-ments and dealing with patent issues. This session will show examples ofthose challenges, resulting from thorough observation and investigationsof the industry, and point out the dimension of change that drugresearch and development staff is presently facing. It will also discuss thecurrent role of “e-Clinical” in this environment and give an opinion if -from a technology and process standpoint - we are where we planned tobe years ago.

Welcome AddressBrigitte Franke-Bray, DIA Europe, Switzerland

The Changing World of Clinical Trials Peter Joshua, CMR International, UK

e-Technologies in Clinical Research:Progress and Obstacles in Industry Adoption and Effective UseRonald Waife, Waife & Associates, Inc., USA

12:30 Sandwich Lunch for Tutorial Participants only

14:00 OPENING PLENARY PART 1

15:30 Coffee Break in the Exhibition Area

17:30 Networking Reception in the Exhibition Area

16:00 OPENING PLENARY PART 2

Our Regulatory Framework - For Better or For Worse?

The Changing World of Clinical Trials

Clinical Operations Role in Achieving Regulatory Compliance when Deploying eTechnology Solutions in Clinical Trials Parallel Tutorial 4

Co-Instructors:Anders Nyberg, H. Lundbeck A/S, DenmarkNeil Konopka, Phase Forward, UKFergus Sweeney, EMEA, EU

For almost 20 years the pharmaceutical industry has struggled with the implementation of new, electronic based technology such as EDC and the use ofeCRFs. For many years nothing really happened but the last 5 years have shown a tremendous increase in the application of electronic tools to a widerange of clinical processes. Associated with the expanded use of e-tools has increased scrutiny by both the internal Clinical Quality Assurance (CQA) depart-ments and the external regulators. This tutorial will give a short introduction to the regulatory framework (including “hot topics”) and will address some key areas of concern during trialplanning to avoid problems later on in the lifecycle of the trial. Examples of audit observations in connection with site audits of e-trials will be provided.

Learning Objectives - at the conclusion of this tutorial, participants should be able to:1. Discuss regulatory framework 2. List examples of audit observations which could have been avoided with better planning3. Describe how to manage your site to achieve regulatory compliance when using e-technology solutions4. Recall strategies for starting/running/completing a trial using e-technology

Target Audience:Clinical research managers and CRAs working, or plan to work, with e-tools. However, clinical data managers, EDC coordinators and CQA personnel willbenefit from discussions around the auditing process with reference to observations and what to do to avoid them.

12:30 CONFERENCE REGISTRATION / EXHIBITION OPENS

09:00-12:30 PARALLEL TUTORIALS (optional)


MONDAY, NOVEMBER 6, 2006 - PARALLEL TUTORIALS Note: These Tutorials are in parallel


9:00 Session 1REGULATORY REALITIES

Session Chairperson:Franziska Falk, Astellas Pharma GmbH, Germany

The changes in the world of clinical trials caused by new medicalfindings and other demands are a challenge not only for thepractical implementation but also for the regulatory frameworkwhich needs to be adjusted continuously in order to ensure theprotection of the study subjects. This session will cover topicsfrom three different aspects of the changing regulatory reality ofclinical studies: adaptation of trials to special populations - thechildren, enhancement of the protection of subjects byintroducing new safety measures - the ECG Global RegulatoryImperative and defining regulations for emerging countries.

Pediatric Clinical Trial and Pediatric PMS Commitments canbe Expected from the EU Pediatric Regulation and the DraftEMEA Guideline on Pharmacovigilance in ChildrenKlaus Rose, F. Hoffmann-La Roche AG, Switzerland

The ECG Global Regulatory Imperative for Cardiac Safety John Blakeley, eResearch Technology, UK

Current Clinical Trial Realities: An FDA Reviewer’sPerspectiveSteve Wilson, FDA, USA

10:30 COFFEE BREAK IN THE EXHIBITION AREA

11:00 Session 2CLINICAL PERSPECTIVES ON GLOBAL EDC STRATEGIES

Session Chairperson: Ingrid Klingmann, Pharmaplex, Belgium

Implementing an EDC strategy is influenced by geographicalreach, clinical objectives and practical constraints. Harmonisingtechnology with clinical objectives can result in contrastingapproaches, that may vary between sponsors and CROs. Thissession will explore the relationship between different strategiesand approaches to ensure success.

Running EDC at Global ScaleMiguel Pérez Vasquez, Boehringer Ingelheim GmbH, Germany

EDC in Eastern Europe - Myths and Reality Kremena Georgieva, Comac Medical Ltd., Bulgaria

Planning for Successful Adoption of EDC:a CRO Clinical Monitoring ViewJane Bentley, i3 Research, UK

12:30 LUNCH BREAK IN THE EXHIBITION AREA

14:00 Session 3SITE PERSPECTIVES ON NEW TECHNOLOGIES

Session Chairperson: Milen Vrabevski, Comac Medical Ltd., Bulgaria

How do sponsors' intiatives with new technology impact theclinical site operations? Are the realities truly understood by theclinical trials’ sponsors and accommodated in the planning? Thissession will provide three such perspectives, focused on threedifferent aspects of implementation.

In search of Site FriendlinessMette Mackeprang Bruhn, H. Lundbeck A/S, Denmark

Drug Accountability: Notes from the FieldNikki Dowlman, ClinPhone Group Limited, UK

Experience of using EDC in Academic Clinical TrialsPatrick Chevarier, ClinInfo SA, France


16:00 Session 4GEOGRAPHIC CONTRAST IN MANAGING GLOBAL TRIALS

Session Chairperson: Stuart Cummings, Consultant, Belgium

In the last few years, pharmaceutical development has becometruly global driven by strong economic growth and the rapidexpansion of outsourcing strategies and technologyinfrastructure, particularly in Eastern Europe and Asia. Thisgeographic expansion has encouraged sponsors to exploreinnovative strategies with regard to site selection, patientrecruitment and the use of data capture technologies thatmaximise the opportunities these new countries offer. Success,however, is also highly dependent on understanding oftencomplex cultural issues and ensuring that an effectivecommunication strategy is deployed. This session will focus onand compare the key opportunities and challenges that drivesuccessful clinical trials in emerging countries.

Cost Effective Patient Recruitment in "Super Sites"Jane Restorick, Synexus Clinical Research plc, UK

The Clinical Trial Hub - How to Manage Complex ClinicalTrial Organisations in Central and Eastern EuropeGeorg A. Mathis, Appletree AG, Switzerland

Voice of the Patient: Global ePRO TrialsPhil Lee, PHT Corporation, USA

17:30 NETWORKING RECEPTION IN THE EXHIBITION AREA

Parallel Track 1 CLINICAL RESEARCH




Parallel Track 1 CLINICAL RESEARCH

09:00 Session 5IMPROVING CLINICAL TRIAL PROCESSES

Session Chairperson: Richard Nelson, PharmaNet Inc., USA

Implementation of evolving technologies requires carefulplanning to maximise success, as well as to avoid pitfalls. Thissession will focus on evaluating different operational aspectsand strategies and planning appropriately to improve the clinicaltrial process.

Clinical Trial Management (System Integration/Interface)Peter Bayer, H. Lundbeck A/S, Denmark

Writing Better Clinical Study Protocols: No Small Task, but PossibleIonel Mitrica, CATO Research Ltd., USA

Hybrid Data Capture Studies: Operational Considerationsfor Clinical, Data Management and QARichard Nelson, PharmaNet Inc., USA



15:45 END OF CONFERENCE

11:00 Session 6 Joint SessionPRACTICALITIES OF MANAGING EDC STUDIES


EDC systems are rapidly evolving, as advances in technologyoffer more elegant solutions. However, this presents continuouschallenges to the practitioners as they have to balanceembracing new technologies with the efficient execution oftheir clinical programmes. This session focuses on how clinicaloperations can achieve the ideal balance and progress at anoptimal pace.

EDC from the Study Manager's Perspective - Implications on Time, Quality and ResourcesFranziska Falk, Astellas Pharma GmbH, Germany

e-Monitoring: How EDC has Changed the CRA’s LifeFrançois Simon, Serono International, Switzerland

EDC around the Globe - the Reconciliation of ClinicalResearch FunctionsEd Ikeguchi, Medidata Solutions, Inc., USA


The purpose of this final session is to visualise how technology solu-tions linked to process optimisation and innovative organisationaldesigns can drive improvements in scientific pharmaceutical develop-ment. This session will explore the following three premises:

• Sponsors, study investigators and regulatory authorities must antic-ipate the benefits that will result from the universal introduction ofEDC solutions, combined with the promise of an eHealth environ-ment that will allow direct access to patient data for clinical and epi-demiological research purposes.

• Pharmaceutical companies must optimise global processes and setbest practices with the goal of delivering ‘Six Sigma’ improvementsthat can be easily adapted in response to the emergence of new tech-nologies that will continue to enhance the clinical trial operating envi-ronment.

• Contract research organisations (and increasingly pharmaceuticalcompanies) must build truly global organisations and develop tech-nology solutions that will enable emerging countries to become fullpartners in the worldwide search to research, develop and obtainmarketing authorisation for new medicines.

The Future of eHealth and Clinical Data SolutionsRichard Perkins, eClinical Forum, France

Optimising Project Delivery - The Pfizer Clinical Trial BlueprintMike Collins, Pfizer, USA

Riding the Learning Curve Gerhard du Toit, Quintiles Global Data Management, USA

Closing Remarks

14:00 CLOSING PLENARY

Is Technology Driving Science?


9:00 Session 1PRACTICAL EXPERIENCES WITH EDC

Session Chairperson: Stéphane Marzabal, Serono International, Switzerland

With the widespread adoption of EDC in the pharmaceuticalindustry, real sponsor experiences are becoming more prevalent.Through this session we will look at the steps that a companyshould explore when implementing EDC. You will hear aboutthe experience throughout the EDC system selection process,the steps of implementation and the gaps that can beencountered as the new system is adopted and the processsupport required to make EDC a success in the time and qualitydimensions.

Accelerating EDC DecisionsStephen Rhys Thomas, Procela Partners, UK

The Data Cleaning Process In- and Outside of EDC Who Should Do What and How?Andreas Grass, Bayer Vital GmbH, Germany

New Technology in Clinical Data Capture: One Size Fits All?Vicente Rodriguez, Lilly, Spain


11:00 Session 2ePRO

Session Chairperson:Eva Hammarstrom-Wickens, Orion Pharma R&D, UK(INCDMA Representative)

A compelling reason for using electronic Patient ReportedOutcome (ePRO) is the immediate access to clinical data whichare more accurate and complete in comparison with paperdiaries. However, experience to date with the validation of mostPatient Reported Outcomes has been with paper formats. Thecurrent change to electronic data capture (PDA, tablets and IVR)requires reformatting and rewording of these precisionmeasurement instruments. If carefully formatted and tested,electronic devices can capture data that are concordant with theoriginal validated paper version. This session will address thevalidation of patient reported outcome data from paper toelectronic format. In addition you will learn about the criticalissues that need to be considered when setting up andconducting ePRO studies using both handheld devices andinteractive voice response systems and potential return oninvestment for key stakeholders.

Adapting Validated Paper Questionnaires (PROs) for EDCDimitri Stamatiadis, Serono International SA, Switzerland

Trials and Tribulations with ePRO Rainer Richter, Grünenthal GmbH, Germany

What's In it for Me? The ROI for eDiaries Jean Paty, invivodata Ltd., USA


14:00 Session 3ROLE OF PEOPLE IN eCLINICAL

Session Chairperson:Sébastien Pourchaire, BlueLinea, France

New technologies not only affect how we work but who we are.Just look in your pocket and you will find one or more of thefollowing devices: a GSM, maybe a PDA, a Blackberry, a DigitalPen, a Bluetooth Headset, or more.But is it just the gadgets that we use that have changed inrecent years? No - it is also our behaviour related to how we usethem. To be connected with your familiy or your place of workis no longer dependent on distance. In a similar fashion, it is notonly the tools that have changed the way in which we conducta Clinical Trial; it is also our working processes and our skills thathave adapted. During this session we will assess how ClinicalTeams use new technology as a tool to improve their owneffectiveness in the conduct of clinical trials.

Are Integrating Technologies, Data Standards, NewProcesses, and Changing Role Definitions Enough to DelivereClinical? We need to put People at the Heart of eClinical Michael Schuitevoerder, Team Technology Limited, UK

Facilitating Study Collaboration through Web-BasedInformation Sharing and Documentation: Clicking with CommunicationsWinston Liao, Fulcrum Pharma Developments, Inc., USA

EDC – Formulating a Global UnderstandingDavid Quarm, Medidata Solutions Inc., UK


16:00 Session 4TECHNOLOGY FOR TOMORROW?

Session Chairperson:Valdo Arnera, PHT Corporation, Switzerland

Within DIA, one of the roles of the eClinical SIAC is to facilitatethe exchange of information on new technologies that may helpthe clinical trial process in the future. This session will provide aforum where we discuss what’s new, addressing potential areasfor improvement where technology can assist us. What are thelimitations in the clinical trial arena? What will we do tomorrowthat we couldn’t do yesterday?

A Vision for the Future of Trials ManagementMike Bartlett, H. Lundbeck A/S, Denmark

Before EDC - Technology for Protocol DesignCharles Beitz, Fast Track Systems, USA

Central Analysis of Video Image Data using the Exampleof Laparoscopic DataGunter Bellaire, Perceptive Informatics, Germany


Parallel Track 2 eCLINICAL







11:00 Session 6 Joint Sessions


Parallel Track 2 eCLINICAL

09:00 Session 5 Joint Session

FDA - CDISC INTERACTIONS


It appears there is widespread confusion about which of the many standards should be understood and implemented, particularly in theregulated medical product development arena. This session will cover a) standards and standards-related activities relevant to thebiopharmaceutical industry, b) how these standards can and should work together to streamline processes, including clinical trials andregulatory reviews and Critical Path initiatives and c) collaborative initiatives within and across industries.

Overview of current FDA Initiatives around eSource, Standards and RepositoriesSteve Wilson, FDA, USA

Technical Roadmap and ODMDavid Iberson-Hurst, Assero Limited, UK

Collaborative Activities Towards Standards HarmonisationRebecca D. Kush, CDISC, USA

PRACTICALITIES OF MANAGING EDC STUDIES


EDC systems are rapidly evolving, as advances in technology offermore elegant solutions. However, this presents continuous challengesto the practitioners as they have to balance embracing newtechnologies with the efficient execution of their clinical programmes.This session focuses on how clinical operations can achieve the idealbalance and progress at an optimal pace.

EDC from the Study Manager's Perspective - Implications on Time, Quality and ResourcesFranziska Falk, Astellas Pharma GmbH, Germany

e-Monitoring: How EDC has Changed the CRA’s LifeFrançois Simon, Serono International, Switzerland

EDC around the Globe - the Reconciliation of CR FunctionsEd Ikeguchi, Medidata Solutions, Inc., USA

DATA STANDARDS - TECHNICAL PERSPECTIVES

Session Chairperson: Jens Reinhold, Schering AG, Germany

This session will focus on practical and technical aspects of using datastandards for clinical development and key topics will be:• New features of the CDISC ODM Version 1.3 and its role in the

submission to regulatory authorities including the model forelectronic case report forms

• Methods and strategies for using current CDISC models from studydesign to using EDC and the integration of external data sources

• The necessity of Controlled Terminology, the CDISC & NCI colla-borative process in working on a Controlled Terminology for CR

The Ever Expanding Role of the ODMDavid Iberson-Hurst, Assero Limited, UK

From Protocol to Submission - The Value of Using CDISCStandards: Experiences from a Long-Time ImplementerJozef Aerts, XML Consultant, Germany

CDISC Controlled Terminology Initiative - A Collaborationbetween CDISC and NCIAndreas Gromen, Schering AG, Germany

Session Chairperson: Stuart Cummings, Consultant, BelgiumThe purpose of this final session is to visualise how technology solutions linked to process optimisation and innovative organisational designs candrive improvements in scientific pharmaceutical development. This session will explore the following three premises:• Sponsors, study investigators and regulatory authorities must anticipate the benefits that will result from the universal introduction of EDC solu-tions, combined with the promise of an eHealth environment that will allow direct access to patient data for clinical and epidemiological researchpurposes.• Pharmaceutical companies must optimise global processes and set best practices with the goal of delivering ‘Six Sigma’ improvements that canbe easily adapted in response to the emergence of new technologies that will continue to enhance the clinical trial operating environment.• Contract research organisations (and increasingly pharmaceutical companies) must build truly global organisations and develop technology solu-tions that will enable emerging countries to become full partners in the worldwide search to research, develop and obtain marketing authorisa-tion for new medicines.





Riding the Learning CurveGerhard du Toit, Quintiles Global Data Management, USA

Closing Remarks


9:00 Session 1CODING

Session Chairperson: Joris Cauquil, AMITIS/Effi-Stat-DMB Chairman, France(INCDMA Representative)

The changing face of coding: what do we need to do in thefuture that we didn’t do in the past? The following three topicswill be addressed:• training strategies for investigators’ sites and company

personnel for MedDRA • how and when to switch to the C format for WHO Drug

Dictionary • implementation scenarios for SNOMED

Training Strategies to Improve Data Quality and OptimiseCoding with MedDRA Eva-Beate Rump, Consultant to MedDRA MSSO, Germany

WHO Drug Dictionary - From B-Format toC-Format: More than a Technical ChangeKerstin Kühn, Accovion GmbH, Germany

SNOMED CT® - A Standard Terminology for HealthcareDoris McGinness, SNOMED International, USA


11:00 Session 2PROCESS IMPROVEMENT

Session Chairperson:Gilbert Bellachen, Oracle Corporation, France

The rapidly evolving clinical operations environment demandsthat we continually re-assess our procedures. This change maybe associated with the introduction of new technology, therestructuring of organisations, adoption of standards or simplya response to inefficiency concerns. In all cases the impact ofnew processes need to be monitored and measured. In thissession we will hear about specific examples of processimprovement and take a look at what strategic approaches canbe adopted.

End-to-End Implementation of a CDISC-Based Data Flowfrom eCDM to a Clinical Data Warehouse and AnalysisSystem: The Data Manager's View Kurt Hellstern, Hands-on LLC, Switzerland

Data Integration, Analysis, and Reporting with CDRSharon Marmaras, Boehringer Ingelheim Pharmaceuticals, Inc.,USA

Beyond Initial EDC Adoption: The Tools and the Process /LSHJoseph Anderson, Waife & Associates Inc., USA


14:00 Session 3METRICS

Session Chairperson: Peter Stokman, NV Organon, The Netherlands

Metrics? Not just to contrast and to compare, but also to gaugethe effects of new processes and strategies. This session willstart with a view from 30,000 feet at the consequences of newdevelopment strategies for the overall metrics of companies.Subsequently we will zoom in on the essentials of developingnew metrics in a data management environment and lastlyshow how metrics can help implement EDC and the associatedinter-departmental workflow and business model re-definition.

Changing Strategies Reflected in MetricsMary Jo Lamberti, Thomson CenterWatch, USA

How to Develop Metrics for Data Management ProcessesNorbert Fritz, F. Hoffman-La Roche AG, Switzerland

Metrics, EDC implementation and Business ModelAdrian Hsing, Gilead Sciences Inc., USA


16:00 Session 4QUALITY FIT FOR PURPOSE

Session Chairperson: Pieter Voermans, F. Hoffmann-La Roche AG, Switzerland

This session will cover the circle of quality from preparing for aclinical trial, through conducting and evaluation by ClinicalQuality Assurance giving recommendations on how to do itbetter for the subsequent tiral. Case studies will includereference to traditional trials employing paper CRFs and alsostudies conducted using EDC. In fact the introduction of newtechnologies such as EDC and an increasing trend towardoutsourcing has made the classical end-of-trial audit as ameasure of data quality obsolete. How can sponsors be assuredthat quality expectations are fully met?

How Clinical QA can Help to Implement New Role Conceptsand Processes for EDC Trials - Some ExperiencesUwe Lohmeier, Schering AG, Germany

Strategies for Clinical Data Quality ManagementReza Rostami, Duke Clinical Research Institute, USA


Parallel Track 3 CLINICAL DATA MANAGEMENT (CDM)



10:30 COFFEE BREAK IN EXHIBITION AREA

12:30 LUNCH BREAK IN EXHIBITION AREA



Parallel Track 3 CLINICAL DATA MANAGEMENT (CDM)

09:00 Session 5 Joint SessionFDA - CDISC INTERACTIONS


It appears there is widespread confusion about which of themany standards should be understood and implemented,particularly in the regulated medical product developmentarena. This session will cover a) standards and standards-related activities relevant to the biopharmaceutical industry, b)how these standards can and should work together tostreamline processes, including clinical trials and regulatoryreviews and Critical Path initiatives and c) collaborativeinitiatives within and across industries.

Overview of current FDA Initiatives around eSource,Standards and RepositoriesSteve Wilson, FDA, USA

Technical Roadmap and ODMDavid Iberson-Hurst, Assero Limited, UK

Collaborative Activities Towards Standards HarmonisationRebecca D. Kush, CDISC, USA

11:00 Session 6 Joint SessionDATA STANDARDS - TECHNICAL PERSPECTIVES

Session Chairperson: Jens Reinhold, Schering AG, Germany

This session will focus on practical and technical aspects ofusing data standards for clinical development. Key topics will be:

• New features of the CDISC ODM Version 1.3 and its rolein the submission to regulatory authorities including themodel for electronic case report forms

• Methods and strategies for using current CDISC models from study design to using EDC and the integration ofexternal data sources

• The necessity of Controlled Terminology, the CDISC & NCI collaborative process in working on a Controlled Terminology for clinical research

The Ever Expanding Role of the ODMDavid Iberson-Hurst, Assero Limited, UK

From Protocol to Submission - The Value of Using CDISCStandards. Experiences from a Long-Time ImplementerJozef Aerts, XML Consultant, Germany

CDISC Controlled Terminology Initiative - A Collaborationbetween CDISC and NCIAndreas Gromen, Schering AG, Germany


The purpose of this final session is to visualise how technology solu-tions linked to process optimisation and innovative organisationaldesigns can drive improvements in scientific pharmaceutical develop-ment. This session will explore the following three premises:

• Sponsors, study investigators and regulatory authorities must antic-ipate the benefits that will result from the universal introduction ofEDC solutions, combined with the promise of an eHealth environ-ment that will allow direct access to patient data for clinical and epi-demiological research purposes.

• Pharmaceutical companies must optimise global processes and setbest practices with the goal of delivering ‘Six Sigma’ improvementsthat can be easily adapted in response to the emergence of new tech-nologies that will continue to enhance the clinical trial operating envi-ronment.

• Contract research organisations (and increasingly pharmaceuticalcompanies) must build truly global organisations and develop tech-nology solutions that will enable emerging countries to become fullpartners in the worldwide search to research, develop and obtainmarketing authorisation for new medicines.



Riding the Learning Curve Gerhard du Toit, Quintiles Global Data Management, USA

Closing Remarks




FLOORFLOOR PLANPLAN

ExhibiExhibition Hours/Stion Hours/Schedule chedule Monday November 6 Exhibition 13.00-18.30

Coffe Break 15.30-16.00

Reception 17.30-18.30

Tuesday November 7 Exhibition 10.00-18.30


Lunch Break 12.30-14.00

Reception 17.30-18.30

Wednesday November 8 Exhibition 10.00-14.00


Lunch Break 12.30-14.00

Wednesday November 8 Tear Down 14.00-17.00

Company Name Country Booth No.

Accovion Germany 37CCL Label Oss BV The Netherlands 39CDISC United States CClinPhone Group Ltd. United Kingdom 35, 36CRF Inc. United States 18CTC/Phocus Switzerland 10DataLabs Inc. United States 38DATATRAK International United States 1Eclinso Switzerland 4entimo AG Germany 30eResearch Technology United States 26etrials Inc. United States BF. Hoffmann-La Roche AG Switzerland 25Fisher Clinical Services Switzerland 31i3 Statprobe United States 11ICON Ireland 12, 13Image Solutions Europe GmbH Germany 40Imperial Clinical Research Services Inc. United States 17INC. Research United States 2INCDMA United Kingdom AInternational Drug Development (IDDI) Belgium 9invivodata Ltd. United Kingdom 24Kendle United Kingdom 6Key People United Kingdom 23Medidata Solutions United States 19Metronomia Clinical Research Germany 21NNIT Switzerland 22, 15Oracle United Kingdom 7Paragon Biomedical Limited United Kingdom 41PAREXEL International/Perceptive United States 42PharmaForms GmbH Germany 32Phase Forward France 28, 29PHT Corporation Switzerland 3Quintiles United Kingdom 33, 34Richmond Pharmacology United Kingdom 20SGS Belgium 27The Uppsala Monitoring Centre Sweden 16TransPerfect Translations Switzerland 8Viasys Healthcare GmbH Germany 14Waban Software United States DXclinical GmbH Germany 5

EXHIBITINGEXHIBITING COMPANIESCOMPANIES

European Clinical Research Conference • European eClinical ...

Documents

Transcript of European Clinical Research Conference • European eClinical ...