Programme

Graham Bunn
Member
CDISC

CDISC: examining the latest practical experiences and end-to-end data standardisation

• Identifying the current status of the CDISC standards activities and models, such as the Operational Data Model (ODM) and the Analysis Data Set Model (AdaM)
• Examining the hands-on experience of adapting and integrating CDISC models into e-Clinical Systems
• Future technologies and technology models in progress, such as the development of standards for laboratory data and the exchange of non-clinical data
• Understanding the future business opportunities and strategies for CDISC

Trudy Kuipers-de Groot
Manager,
EDC & Biometrics Support
Astellas

Robert Snijder
Manager Clinical Programming
Astellas

International standardisation through the implementation of a global EDC system

• Approach taken to global standardisation:

• Process
• Input: standardisation in use of an EDC system
• Output: standardisation outside of an EDC system

• Downstream vs upstream standardisation
• Next step: use of standards in clinical reporting

Better control of the e-Clinical Trials process: improving the inter-departmental network

• Acknowledging the need for accurate communication and interoperability between different departments and systems
• Managing global departments: how to develop international networks and processes
• Integrating work practices and communication: from drug safety through to the Clinical Trial functions
• Setting up the internal e-systems to train and manage staff

End-to-end electronic data flow from protocol to submission

• From protocol to metadata - enhancing the design process
• Employing new technologies to improve efficiency and user experience at the investigational site
• Integrating data from various sources
• Standardisation and validation

Industry case study: implementing an EDC system while working on advancing your overall efficiency

• Challenges in implementing an EDC system in a short time frame
• How to maintain the current metric whilst improving operational efficiency
• What are the best procedures for gaining greater benefits of e-technology to your clinical trials?

Is EDC the next CDMS?

• Examining how CDMS has traditionally worked as the primary system for the data manager – and how this is changing
• Providing a view of how today’s EDC platforms can be handled without the separate overhead of deploying and managing a CDMS database
• Analysing the pros and cons of evolving to EDC from CDMS

The perfect EDC system: an investigator’s view

• Reviewing the critical aspects and actual process of EDC at the site
• Understanding the procedures: sourcing documents, using worksheets and maintaining files
• Establishing how useful the use of a web portal is for information and data sharing during the study
• How intrusive is an EDC study at site level? What are sponsors doing to compensate for the work the site has to absorb for EDC?

PRESENTATION AND PANEL DISCUSSION:
Integrating sponsor and investigator technologies for best results

• Re-assessing EDC and the effect of disparate technologies on investigator sites
• Understanding the importance of interoperability between research and patient data
• Working together to facilitate and control different/new technology systems
• Establishing a continuity of knowledge and setting up user-friendly systems for accessibility

Best practices and processes for effectively archiving e-Clinical data

• Establishing the rules to good archiving and where and how to archive
• Accessibility: determining who should have access to the archive at the site
• What are the guidelines to record management and electronic systems?
• Understanding the importance of accountability and corporate compliance

Implementing e-Clinical Technologies

• Increase clinical trial speed and effectiveness by adopting e-Clinical technologies and services
• Scale your clinical operations while reducing costs by outsourcing e-Clinical support services
• Service global clinical sites by tapping into near-shore technical resources

How to efficiently manage global Clinical Trials using one e-Collaboration platform

• Setting up the e-Collaboration platform as the main system to share the most relevant information across organisations
• Identifying key business requirements to configure the e-Collaboration working procedures
• Managing huge volumes of documentation and clinical data transfers into one central repository
• System training and support, tools and procedures
• Benefits of using an e-Collaboration platform in global Clinical Trials

Challenges in EDC provisioning – keeping up with global Clinical Trials

• EDC provisioning and the strategy vs. reality
• EDC on three continents: what challenges does that provide during site qualification and during ongoing trials?
• Is provisioning a job to be outsourced or undertaken in-house?

Integrated electronic data flow from data collection to medical review

• Bidirectional electronic data transmission between Investigator and Medical Reviewer
• Impact on data modelling
• Quantitative aspects

Jens Reinhold
Director EDC/ e-PRO Implementation Management
Bayer Schering

Global e-Diary applications - a sure-fire success?

• Global e-Diary operations from a sponsor perspective
• Sponsor/CRO/Vendor relationships and management in a multinational EDC/e-Diary trial
• Expectations and reality
• Lessons learned

Use of metrics in the clinical organisation: measuring impact of new processes

• Developing metrics in a data management environment
• Using metrics to measure the cost, time and quality benefits of using an EDC
• The broader scope of metric's use (forecasting and evaluating)
• What are the uses of these metrics at the Clinical Development Organisation level?

Adaptive design: managing EDC as the Clinical Trial progresses

• Adapting, moving, extending Clinical Trials – realising how this impinges on the data and system validation
• How does this affect the overall cost of the system and the trial?
• Adaptive trials: is this the future for e-Clinical Trials?

Best practices in integrating a range of systems for a successful e-Clinical programme

• Appreciating the difficulties for e-Clinical and IT departments to initiate, keep track and integrate several systems
• Creating a global network: from EDC implementation through a network of data warehousing to managing a global IVRS system
• How to join these various elements together to build a successful business architecture platform
• Practical examples of creating and using this approach for global Clinical Trials