The Programme

Day One: Tuesday 20 May 2008

08:00 

Registration and coffee

08:30

Alastair Clewlow
Head of Clinical Data and Document Management
LEO PHARMA

Opening remarks from the Chair

08:40

Martin Semrau
Enterprise Architect
NOVARTIS

Clarifying the evolving landscape: service oriented architecture (SOA)

• Moving towards a more dynamic e-clinical trial structure
• Understanding the need for a smoother infrastructure
• Reacting to the changing landscape of clinical trials by creating SOA

09:15

Uwe Barlage
Project Leader EDC
BAYER

Theory vs practice: eCRF development in EDC systems

• Who develops eCRFs in pharma companies?
• Custom eCRF development tools in EDC software suites and their limitations
• Reusability as a major goal in application development
• concepts developed to achieve it
• tools available on the market
• Conclusions and suggestions

09:50

Mats Sundgren
Principal Scientist,
Global Clinical Development
ASTRAZENECA

Combining e-clinical technologies with e-health records

• Evaluating the challenges that have to be tackled
• Examining how best to achieve a seamless integration
• Reviewing how e-clinical trials are evolving and how this can aid with integration

10:25

Morning refreshments

10:55

Steve Lesser
CRO Partnerships
MEDIDATA SOLUTIONS

The role of EDC in adaptive clinical trials

• Understanding how EDC systems are critical to enabling adaptive clinical trials
• Identifying the necessary steps to take and parties to involve when implementing successfully adaptive clinical trials

Henning Lux
Managing Director
QUADRATEK

Streamlining data reviews with integrated e-clinical systems

• Defining data reviews as part of the electronic data validation plan
• Efficient electronic data review in e-clinical systems
• Enhancing compliance with electronic reviews
• Integrating electronic data reviews in the EDC process

Compliance: the impact of the ‘e’ in e-clinical trials on the company, the workforce and the managers

• Defining and articulating the clinical trials process
• Conducting the clinical trial: document management, e-approval, distributed access-distributed resource
• Tracking the clinical trial: productivity, milestones, responsibility
• Analysing the impact of new requirements such as PhRMA Web Synopsis and Article 45

Understanding the evolving industry-wide FDA regulatory requirements for e-clinical trials carried out in Europe

• Highlighting key regulatory standards required by the FDA
• FDA requirements for CRF 21 electronic signatures and records
• Future developments with the recently released FDA Guidance for Industry: computerised systems used in clinical investigations, what are the new recommendations?

Reviewing Novo Nordisk’s EDC implementation process

• Introduction to our system architecture
• How we have implemented EDC as an ASP system
• Transition from project to line organisation
• Future challenges

An end-user perspective on metadata in an e-clinical environment

• What is metadata?
• Automating using metadata
• Some CDISC initiatives using metadata
• In depth overview of metadata in a data management system
• Metadata in "re-usable coding" development

Organising and optimising user support for eCRF studies: lessons learned and new opportunities

• Co-ordinating site set-up activities and site support
• understanding the impact of a user support model on organisations and the whole process
• developing a partnership model with a support vendor
• exploring how the different processes and sops are being adapted
• Tackling the issue of training the sites to work on the trials
• establishing who is responsible for training the sites
• implementing successful training techniques in the available time-frame
• creating an effective and proficient team at the site

Case study: capturing serious adverse event data through the use of RDC/EDC

• Understanding how RDC/EDC can aid in the reporting of adverse events
• Transferring data from the RDC/EDC system to the Drug Safety Data Management system
• Querying SAE data via RDC/EDC
• Improvements in the SAE reconciliation process

ePRO: facilitating the patient experience

• A case study
• Choosing appropriate technology
• Managing user compliance

From "pencil" to "e-study tools": how monitoring has changed

• Using e-study tools to prepare for site monitoring visits
• Clinical trial management system (CTMS): what we can learn
• Statistical analysis and reporting tool (STAR): monitoring a site according to quality control
• The changing role and activities of the CRA/Monitor

Case study: using the digital pen to facilitate clinical trials

• What is the added value of a digital pen?
• How can the digital pen facilitate a clinical trial?
• What has Actelion already achieved?
• What are the next steps to take?

Electronic data capture: a step towards e-clinical trials

• Grunenthal’s strategy in implementing electronic data capture
• Obstacles faced in process re-engineering
• Challenges Grunenthal has faced and those to be tackled in the future