Coordinating center for Clinical Trials Düsseldorf Heinrich Heine University Düsseldorf Setting the Global Standard for Clinical Data Workshops for Insider! International Conference for Clinical Trial Technologies: Truly expensive and time consuming? When: October 14 th 15 th, 2004 Where: PAREXEL Akademie, Berlin Germany Conference under the endorsement of the Senator and Mayor of Berlin: Harald Wolf Page 1 of 7
Senate Department for Economics, Labour and Women s Issues of Berlin Dear Participants, Your conference will continue a serial of meetings about Information and Communication Technology in the clinical and pharmaceutical sector. Both, the problems of interfaces and of economic success are important for software applications used in this field. The question of costs for software becomes of growing interest with the worldwide spread of Clinical Trials. Therefore the discussion about Open Source Software is not only a point of security but of economy. While developing egovernment the public sector in Germany also tests OSS and Berlin has a research focus at the Fraunhofer Institute with the BERLIOSproject. On behalf of the City of Berlin I would like to welcome You to this workshop and hope that You will find not only a good location for discussion but also for culture and sightseeing at the historical sites of our city. Harald Wolf Mayor of Berlin Speakers from CDISC, Strategy Experts, Universities and Technology Providers will give you an overview about current industry trends and advise in best practice. Page 2 of 7
Conference Day 1, October 14 th, 2004 (10:00 18:00 ) Session 1 Impact of CDISC and XML on Clinical Trial Technologies Dave Iberson Hurst Assero Limited Clinical Data Archive. Does the ODM do the Job? Mark Wheeldon Formedix The Impact of CDISC: New Opportunities and Applications Philippe Verplancke, CRO24 GmbH CDISC as a Means of EDC System Cost Reduction and Facilitation of Open Source System Development Jozef Aerts XML4Pharma Affordable Technology for working with CDISC ODM and Lab Standards Session 2 Trends and Costs of Technologies Ulrich Hönig PharmaForms GmbH New Vistas on old Media: Digital Pen and Paper Thomas Bratke Coordination Center for Clinical Trials Cologne The Telematics Platform for Medical Research Networks (TMF e.v.) evaluates the CDISC Interface as a Standard for Data Management Peter Marschall Bayer Vital GmbH PH-MED-Data-EDC Middleware Technology for Collecting Clinical Data Session 3 - Working groups: Key Su Working groups: Key Success Factors, best Technology Strategies Key speakers and conference managers will organize working groups to discuss optimized Technology Strategies and identify Key Success Factors for future development of Clinical Trial Technologies. The day will end with result presentations of working groups. Page 3 of 7
Conference Day 2, October 15 th, 2004 (09:00 17:00) Session 1 - Commercial Vendor Strategy for effective Implementation of Technologies & User Feedback of those Strategies Eva Sellge ias interactive Systems Implementation of CDISC Standards in commercial Clinical Trial Technologies: Changes and Challenges in a Cooperation with academic Partners Ronald Steinhau Entimo AG Unified, Model-based Configuration of Portals for Clinical Studies and Beyond Markus Schmidt Siemens AG Medical Solutions Bridging Clinical Practice and Clinical Research Miriam Neuhaus IMFORM GmbH Taking the Chance: Switch to a professional Clinical Data Management System in a midsize CRO Session 2 Open Source Vendor Stra Open Source Vendor Strategies, tegies, an Alternative? Vendor and User Feedback Mike Calder PhoSCo.com The Technical and Business Model Reasons for Open Source in Clinical Research Nader Salasshari Copenhagen Trial Unit University Hospital Software from a Clinical Trial Unit: Should we share it as Free/Open Source Software (F/OSS)? Dimitrios Venizeleas Coordinating center for Clinical Trials Düsseldorf Open Source in Clinical Trial Software: The Integration Advantage Page 4 of 7
Conference Day 2, October 15 th, 2004 (End: 17:00) Session sion 3 - Working groups: How to integrate new technologies by having limited budget? In times of low budgets it becomes more and more critical to find the best strategies for technology implementation at the first time. Therefore key speakers and conference managers will discuss in working groups new ways of cooperation such as open source communities or building up software development and user consortiums. The day will end with result presentations of working groups. Conference managed and coordinated by: European CDISC Group Coordinating Center for Clinical Trials, Düsseldorf PAREXEL Academy, Berlin Please join this two-days workshop to elaborate the options of commercial products, inhouse developed applications and open source software for commercial and academic users performing Clinical Trials or operating in related industries. We encourage people to attend the meeting who are involved in evaluation, planning and implementation of software that will be mission critical for their respective companies/ institutions. Page 5 of 7
Registration Please complete the attached Registration Form and send it to: PAREXEL-Akademie Phone: +49-30-30685-3091 Klinikum Westend, Haus 18 Fax: +49-30-30685-403 Spandauer Damm 130 E-mail: akademie@parexel.com D-14050 Berlin Travel It is possible to organize your trip through our travel agency: Lufthansa City Center c/o PAREXEL International Phone: +49-30-30685-3022 Fax: +49-30-30685-5098 E-mail: travel@lccberlin.de Please have your credit card available. Prices Industry Rate: Academic Rate: 600,00 Euro (+ VAT) per participant 250,00 Euro (+ VAT) per participant Including documentation, lunch, coffee and cold beverages Social Event Please join the surprising social event for just 35,00 Euro (+ VAT) in the evening of October 14 th. If you are interested, please tick the corresponding box on the Registration Form. Page 6 of 7
Registration - Form PAREXEL Akademie Klinikum Westend, Haus 18 Spandauer Damm 130 D-14050 Berlin Fax: +49-30-30685-403 Tel: +49-30-30685-3091 Clinical Trial Technologies: Truly expensive and time consuming? Date October 14 th 15 th, 2004 Location PAREXEL Akademie Klinikum Westend, Haus W Spandauer Damm 130, D-14050 Berlin For registration please enter the form and post or fax it to the address given above. Last name First name Position Company Street, No. Zip code, city Phone Fax E-mail Date Signature I want to join the social event on yes no (add. cost of 35,00 Euro October 14 th [+VAT]) Internet: E-mail: akademie@parexel.com Page 7 of 7