Programme

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DAY ONE: TUESDAY 23RD MAY 2006
08:30		Registration and coffee
09:00	David A. Dworaczyk Vice President, Clinical Development, King Pharmaceuticals	Opening remarks from the Chair
RE-EXPLORING THE OBJECTIVES AND BENEFITS OF ELECTRONIC CLINICAL SYSTEMS
09:10	Graham Bunn Vice President, Strategic Alliances Medidata	RE-ASSESSING THE BUSINESS DRIVERS AND STRATEGIES FOR THE INTEGRATION AND IMPLEMENTATION OF E-CLINICAL SYSTEMS Establishing the ideas and motivations in setting out e-Clinical projects: why are companies still hesitating? How far have we gone into moving into the next step of integrating e-systems? Understanding the difficulty and analysing the solutions in cost-benefit analysis Implementing electronic trials: constantly focusing on the benefi ts that can be achieved Business strategy and optimisation – can these technologies help with business decisions on projects or outsourcing activities?
09:45	Nicolas Schaltenbrand Head Of Global Data Services Quintiles	TRANSITIONING FROM PAPER TO E-CLINICAL: AN INTEGRATED APPROACH Difficulties and challenges of EDC-projects From paper to e-Clinical: an integrated system to solve this phase of transition Hybrid (Paper/EDC) processes: how we managed to solve these issues in our day-to-day life? Web portal: how can these real-time data be valuable for project management? examples of Key Performance Indicators security and access control practical examples using hybrid data collection process integrated into a single database
10:20		Morning refreshments
10:45	Tatiana Storti Clinical IT Applications Leader Chiron	FROM DATA TO DATA INTEGRATION: CURRENT E-CLINICAL EXPERIENCES AND FUTURE PERSPECTIVES Establishing connections: from CTMS to SAP for an integrating reporting delivery Business & technology: what are the drivers? If systems integrate, how people should integrate? Systems & people integration: challenges and needs Case-study examples
11:20	Judith Reece Director of Strategy and Planning, Clinical Development Astrazeneca	Planning and executing an e-clinical journey in a global company Establishing the strategic approach including scope timelines and benefits Understanding the key processes and organisational structures Driving implementation forwards on a global level Nearing our original destination planning for the next steps
ASSESSING THE LATEST TECHNICAL STRATEGIES FOR E-CLINICAL TRIALS
11:55	Adam Wood Manager of Clinical Outcomes Clinphone	ELECTRONIC PATIENT REPORTED OUTCOMES AND THE NEW DRAFT FDA GUIDANCE REPORT Case studies Review of new draft FDA guidance
12:30		Lunch
13:40	Alistair Clewlow Head Of Clinical Data and Document Management Leo Pharma	CASE STUDY: IMPLEMENTATION OF REMOTE DATA CAPTURE AT LEO PHARMA Impact of RDC on clinical operations on IT Managing process change Cost benefits of RDC vs. paper-based trials Deployment of client PCs Handling user training, administration and support Delivering eSubmission-ready CRFs
14:15	Mike Britt Global Head Pharma Development Quality Systems Validation Roche Products Limited	END-TO-END MANAGEMENT OF E-CLINICAL TRIALS Process vs. technology approach: does the tail wag the dog? What the regulations say (or don’t) How to keep sight of your goal e-Trials: front-loading, at site, in-house Shifting cultures
14:50		Afternoon refreshments
15:15	Valdo Arnera General Manager, Europe PHT Corporation	MEETING THE INCREASINGLY SOPHISTICATED ELECTRONIC PATIENT RECORDED OUTCOME (EPRO) SYSTEMS Electronic Patient Recorded Outcome – the accumulated experience about consequences of better quality data Delineating the reasons why ePRO is easy to adopt and its integration into the technology mix Understanding the future new features that electronic diaries can bring to clinical research Paper vs. electronic: understanding the FDA’s increasing interest in ePRO together with questions raised by eSource
15:50	Miguel Valenzuela Senior Systems Validation Analyst Roche Products Limited	REALISING A BUSINESS SOLUTION FOR ESOURCE: COMBINING TECHNOLOGY AND DEVELOPMENT A 2006 update on the different means through which e-Source can be installed Considering the existing regulations and the use of available industry standards Examining the benefits of eSource for clinical trials as well as the implementation and validation procedures Recognising the future benefits for the industry: can companies start talking about “single source”?
16:25	Robert Bergann Global Head Clinical Data Centre Schering	E-CLINICAL DATA WAREHOUSES - BUILDING A SOLID BASIS Are data warehouses just an ideal? Understanding the challenges and benefi ts of having a clinical data warehouse From infrastructure to standards: establishing the methodologies and approaches to successfully implementing a data warehouse Overcoming the potential challenges: managing data from multiple sources, quality archiving and consistent formatting Outlook: recognising the long-term benefits of e-clinical data warehouses
17:00		Closing remarks from the chair
17:10		Drinks reception Delegates are invited to join the speakers, sponsors and exhibitors at an informal drinks reception sponsored by Datatrak
Jump to Start of Day One
DAY TWO: WEDNESDAY 24TH MAY 2006
08:30		Registration and coffee
09:00	Alistair Clewlow Head Of Clinical Data and Document Management Leo Pharma	Opening remarks from the Chair
EDC IMPLEMENTATION AND INTEGRATION UPDATES
09:15	Beverley Dight Business Support Manager CSDM Operations Pfizer	EXPERIENCES OF USING EDC FOR GLOBAL STUDIES Logistical considerations during study start-up (including discussion about decisions on whether to provide laptops, deployment of laptops, connectivity, timelines…) User training (including pros and cons of hands-on vs. self-teach CD/Web-based training; the role of the monitor in supporting users at site) User support (including language issues, follow-the-sun helpdesk support, issue escalation, monitor’s contribution) Study close-out activities (including discussion of site access to data after end of study, retention of data)
09:50	David A. Dworaczyk Vice President Clinical Development King Pharmaceuticals	OPTIMISING THE COLLABORATION AND REAL-TIME COMMUNICATION BETWEEN EDC AND OTHER SYSTEMS How to optimise the processes and how can it be done? Reviewing real-life examples of linking EDC to IVRS and CTMS Investigating current security issues: who will control the information and how to avoid un-blinding? Round-the-world communication: ensuring real-time interaction between global trials Is integrating and consolidating all the data into a central system the next step?
10:25		Morning refreshments
10:50	Daphne Gerrits Operations Manager Centocor, Johnson & Johnson	CNTO EDC background description of our support model experiences with moving from an offline to online/offline system
11:25	Jeremy Rice and Mark Hammond Clinical Systems & Process Specialists, IBM Business Consulting Services	OPERATING THE ECLINICAL VISION IBM’s eClinical vision Solution components and implementation challenges EDC - a case study
12:00	Mette Mackeprang Bruhn Section Head System Support H. Lundbeck Dr. Fraser Inglis FRCP Glasgow Memory Clinic Golden Jubilee National Hospital Clydebank	DRIVING THE SUCCESS OF AN EDC TRIAL: THE SITE’S PERSPECTIVE OF USING EDC Reviewing the critical aspects and actual process of EDC at the site Understanding the procedures: sourcing documents, using worksheets, maintaining fi les Establishing how useful the use of web portal is for information and data sharing during the study How intrusive is an EDC study at site level? And what are sponsors doing to compensate for the work the site has to absorb for EDC?
12:35		Lunch
FORECASTING FUTURE TRENDS FOR e-CLINICAL TRIALS
13:45	Uwe Barlage EDC Project Leader Bayer	ACCEPTING THE INHERENT PREDICAMENTS IN UPGRADING YOUR EDC SYSTEM: PLANNING AHEAD FOR A SMOOTHER TRANSITION Improving your EDC system – steps to take when updating your EDC system Ensuring the systems’ safety and security during the transition period How to take your lessons learned when planning a new EDC system implementation The importance of creating an adaptable system with extensive capabilities for future changes
14:20	Diego Herrera Clinical IT Manager Almirall	HOW TO DEVELOP ONE E-COLLABORATION PLATFORM FOR THE CLINICAL PROJECTS AND TRIALS MANAGEMENT What was the main objective? Key implementation factors and phases: project management (planning, milestones, responsibilities) technology (integration, standardisation, knowledge and infrastructure) providers (selection and management) system functionalities and tools Challenges after the system goes live: key processes, training and support Understanding the expectations and benefits
14:50		Afternoon refreshments
15:20	Zahid Qayyum Clinical Applications Manager CDM Department Procter & Gamble	PAST, PRESENT AND FUTURE: EDC AT P&G A comparative overview of past and present EDC studies Summary of the key organisational changes instigated to adapt to EDC EDC to SAS: a look at the challenges and associated risk vs. the potential effi ciency and cost reduction Modelling an operational future study going from EDC to SAS
15:55	David Smith Head of Validation Services Roche Products Limited	ARCHIVING OF EDC DATA: ESTABLISHING THE BUSINESS PROCESS Setting up and archiving an integral and accurate archiving system Accessibility: determining who should have access to the archive Authenticity: what are the guidelines for electronic systems and record management? Understanding the importance of accountability and corporate compliance
16:30		Closing remarks from the Chair & Champagne prize draw
16:45		End of conference

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