Truly expensive and time consuming?

(1)

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

15

th

, 2004

Where: PAREXEL Akademie, Berlin Germany

Conference under the endorsement of the Senator

and Mayor of Berlin: Harald Wolf

Harald Wolf

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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 BERLIOS-project.

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.

H HH

Harald Wolfarald Wolfarald Wolf arald Wolf Mayor of Berlin Mayor of BerlinMayor of Berlin 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.

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Conference Day 1, October 14

th

, 2004 (10:00 – 18:00 )

Session 1

– Impact of CDISC and XML on Clinical Trial TechnologiesImpact of CDISC and XML on Clinical Trial TechnologiesImpact of CDISC and XML on Clinical Trial TechnologiesImpact 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 Techno

Affordable Technology for working with CDISC ODM and

logy for working with CDISC ODM and

Lab Standards

Session 2

– Trends and Costs of TechnologiesTrends and Costs of TechnologiesTrends and Costs of TechnologiesTrends 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

The Telematics Platform for Medical Research Networks

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 SuWorking groups: Key SuWorking groups: Key SuWorking groups: Key Success Factors, best Technology Strategiesccess Factors, best Technology Strategiesccess Factors, best Technology Strategiesccess 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.

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th

, 2004

(09:00 – 17:00)

Session 1

- Commercial Vendor Strategy for effective Implementation of Technologies & Commercial Vendor Strategy for effective Implementation of Technologies & Commercial Vendor Strategy for effective Implementation of Technologies & Commercial Vendor Strategy for effective Implementation of Technologies & User Feedback of those Strategies

User Feedback of those StrategiesUser Feedback of those Strategies 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

Unified, Model----based Configuration of Portals for Clinical

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 StraOpen Source Vendor StraOpen Source Vendor StraOpen Source Vendor Strategies, an Alternative? Vendor and User Feedbacktegies, an Alternative? Vendor and User Feedbacktegies, an Alternative? Vendor and User Feedbacktegies, 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: Sho

Software from a Clinical Trial Unit: Should we share it as

uld 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

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th

, 2004

(End: 17:00)

Ses

Session 3

sion 3

- Working groups: How to integrate new technologies by having limited budget?Working groups: How to integrate new technologies by having limited budget?Working groups: How to integrate new technologies by having limited budget?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 Please joinPlease join

Please join this two-days workshop to elaborate the options of commercial products, in-house 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.

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Registration RegistrationRegistration 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: [email protected] D-14050 Berlin Travel TravelTravel 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: [email protected]

Please have your credit card available.

Prices PricesPrices

Prices

Industry Rate: 600,00 Euro (+ VAT) per participant Academic Rate: 250,00 Euro (+ VAT) per participant Including documentation, lunch, coffee and cold beverages

Social Event Social EventSocial Event Social Event

Please join the surprising social event for just 35,00 Euro (+ VAT) in the evening of October 14th_{. If you are interested, please tick the corresponding box on the Registration Form.}

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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

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Company

Street, No.

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Phone

Fax

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Date

Signature

I want to join the

social event on

October 14

th

yes no (add. cost of 35,00 Euro

[+VAT])