Date	February 9, 2006
Place	Estellas, Leiderdorp
Organisation	BMS Working group PSDM

Program:

09:30	Registration and coffee
13:15 ÷ 13:20	Welcome and introduction Anja Heukels (PSDM board member portfolio Data Management) N.V. Organon, Oss
13:20 ÷ 14:05	EDC pilot Rinske Sieders and Trudy Kuipers Astellas, Leiderdorp, the Netherlands
14:05 ÷ 14:50	EDC implementation Mike Bartlett H. Lundbeck A/S, Copenhagen, Denmark
14:50 ÷ 15:15	Coffee/Tea break
15:15 ÷ 16:00	EDC experiences Stéphane Marzabal, Serono International S.A., Genève, Switzerland
16:00 ÷ 16:45	Integration of data capture systems, e.g. EDC and IVR David Fishbach Phase Forward, USA
16:45	Closure and drinks

Summaries:

EDC pilot
Rinske Sieders and Trudy Kuipers
Astellas, Leiderdorp, the Netherlands

Former Yamanouchi Europe started to investigate EDC possibilities almost 2 years ago. The merger with former Fujisawa initiated a global clinical data management project to harmonize Data Management on a Global level (this project includes EDC). The local initiative was continued, as it was important for us to get our own EDC experience in light of the global Data Management project and there was pressure from the clinical department heads to implement EDC.
To get things started, a task force was established (DM and Clinical departments) to create the user requirements, to review potential EDC systems and to discuss suitable studies. It was decided to start with two pilots, one phase I/IIa study and one phase IIb/III study. At this stage, YEU has completed their first EDC study. The presentation will focus on the following topics:

• Steps to EDC pilot for phase I
• EDC system / vendor selection
• Pilot experience, lessons learned
• Phase I specific EDC requirements

EDC implementation
Mike Bartlett
H. Lundbeck A/S, Copenhagen, Denmark

After a number of pilot projects of varying levels of success, in 2004 Lundbeck started implementation of a EDC strategy, with the aim of running 100% of studies using EDC by the end of 2007. Mike will discuss the thought processes behind the strategy, the implementation of the strategy and the current status as well as highlighting some of the, many, things that can go wrong and right and the challenges Lundbeck still faces in achieving 100% EDC.

EDC experiences
Stéphane Marzabal
Serono International S.A., Genève, Switzerland

Serono has been using EDC for more than 5 years over almost 50 trials. Through a completely reengineered process, we have been able to implement successfully this technology, achieving the goals and expectations that were set at the time of the implementation’s decision.
This presentation will show the real return on investment of implementing EDC by comparing the cost of paper trials with EDC trial at Serono. It will also show that even with an initial reengineering, there is still some room for improvement, especially by working on the processes around EDC. Finally, through the result of a recent survey, we will see how EDC is perceived by the sites and where things can still be improved.

Integration of data capture systems
David Fishbach
Phase Forward, USA

The use of electronic data capture (EDC) for clinical trials has shifted within the industry from isolated pilots to wide scale adoption at the enterprise level, and interactive voice response (IVR) systems have been in widespread use for many years. However, many organizations are duplicating efforts across these applications, and may be able to realize additional operational improvements through integration of these systems. This session will explore the value proposition for integrating EDC and IVR, real-world examples, and the fundamental principles of planning and executing an effective integration.