Programme Day One

Opening remarks from the Chair

Analysing the criteria you must use to select the optimal EDC provider to receive quality data and maximum value for your business case

• Exploring the crucial criteria for EDC providers to boost your ability to meet your specific business needs
• Assessing the specific technical advantages of newly available EDC platforms to choose the right equipment for your company
• Learning how to swap the engine whilst still driving at 100mph (170 kmph) to optimise e-processes
• Gaining a global perspective on how to effortlessly and cheaply implement e-processes in the e-world

Unveiling the best way to implement EDC in order to speed up the process and achieve full machine executability in database reading

• Analysing the decision-making process of EDC technology adoption in order to minimize trial and error
• Evaluating EDC solutions and tools to ease purchase decisions and assess long-term impacts
• Assessing the strengths of a single EDC application against the viability of using various EDC applications
• Defining the optimal timeline of EDC integration in order to identify at which stage of business operations to start using electronic data recording
• Evaluating the viability of CRF library systems and creating a single source database to automate data flow and avoid re-entering data

Improving EDC system integration during its second generation to increase data quality and overall productivity.

• Getting expert insight into the future of EDC development in order to make more informed decisions about purchases
• Achieving comprehensive knowledge of the very latest systems and their practical implementation in order to be one step ahead of data management evolution
• Understanding that electronic data recording saves time and money in contrast to paper-based data capture, while assessing real electronic necessity
• Accomplishing real EDC cohesion within your established database architecture to maximise data access

Case study: Reflecting Baxter's process perspective on streamlined data integration for Remote Data Capture to efficiently manage clinical study data

• Controlling the bulk of data influx and synchronising timelines to resolve the data integration predicament
• Standardising database systems and data formats to improve departmental interoperability, smoothen out time lapses and quicken data delivery to investigators, data monitors and statisticians
• Constructing uncomplicated and straightforward protocols to optimise electronic end-to-end alignment processes and strengthen internal structures
• Analysing the role of CDISC in process standardisation in Data Management

Simplifying the transfer of data to different technology systems and uniting software languages to remove the barriers to effective data integration

• Ensuring that EDC technologies, platforms and data formats are designed to work together
• Safeguarding that your IT systems will fulfil your needs and work together to promote technical interconversion
• Examining effective methods to make EDC implementation work
• Ensuring that the processes utilised during data integration have given rise to data that is correct and true
• Ensuring that data is received in a format you want

Technology updates and their effects on Data Management: highlighting how third-generation data collection devices can add value to EDC, ensuring better quality and simpler procedures

• Exploring the limitations of EDC and admitting their existence to reduce their impact and transitioning EDC into a truly best practice
• Analysing the application of the Digital Pen and assessing its benefits as a third-generation data collection device to overcome EDC limitations
• Investigating criteria for an effective EDC system decision-making process to optimise system analysis and its underlying process
• Explaining how the Digital Pen and Paper technology helps to streamline and improve the CRF data handling in clinical trials to reduce data collection time

Comparing the most novel and advanced technological solutions for EDC systems: Oracle Clinical, Medidata Rave and Phase Forward InForm

• Inspecting three major vendors and their latest plans for EDC technology in order to carve a competitive advantage for third generation EDC application
• Evaluating the usability of EDC technology for investigators and study nurses
• Examining the availability of a data status tracker to efficiently extract data information out of the database system and monitor data integrity of patients
• Exploring breakthroughs in EDC technology to assess the progress towards a solution to CDISC-compliant data collection

Analysing the interaction between between systems for health records and data capture in clinical studies during its "gold standard" generation to increase data quality and speed up data cleaning

• Assessing the need for electronic health record systems to aid the development of a computerised infrastructure and increase efficiency in public health
• Drafting effective methods for efficient EDC-EHR cooperation to reduce training requirements for site staff and harmonise interaction between data managers, data monitors and sites
• Exploring the potential of an EDC server to store EHR host mode data to simplify the coexistence of EDC and EHR
• Generating a "private flag" to maximize the protection of personal data

Clarifying query management methods and metrics to reduce work fragmentation in the clinical knowledge chain and reduce the necessity of being on-site

• Streamlining the query resolution process for task clarification purposes within EDC system integration
• Building effective and dynamic relationships with your site staff to minimise trigger queries and decrease data cleaning activities at the investigator's site
• Resolving expected and unexpected queries and using metadata to improve the quality of data flow: a case study
• Harmonising classical boundaries into an "in-system" query world which includes randomisation systems and external data to simplify data documenting and recording within databases
• Writing end-user specifications for multiple electronic data recording platforms to simplify user-acceptance testing and maximise data quality control
• Using telemedical devices for Blue-Tooth technology-based data transfers to reduce the time it takes for data to be incorporated into the database

Case study: Guaranteeing successful submission by ensuring CDISC compliance across the platforms of drug R&D at GlaxoSmithKline

• Exploring GSK's past, current and future adoption of CDISC standards to help shape your company's journey to successful CDISC integration
• Drafting a clear plan of how the Information Model is used in order to implement and comply with BRIDG and ISO standards
• Investigating the fundamental shift in the approach to 'Data Standards' through the use of an Information Model to ease data standardisation
• Exploring the reasons behind GSK's decision not to implement some of CDISC's suggested standards, including SDTM and CDASH to help you make the right decision about what approach to take with data standardisation

Simplifying the process of data cleaning, validation and mapping through innovative user-friendly case report forms, data base fields, and meta data description

• Working together towards a standardised approach for creating electronic CRFs with the use of CDASH in order to minimise data discrepancy
• Defining clinical domains and creating a CRF library of optimal lay-outs to define what data must be collected in order to guarantee top-quality analysis
• Standardising messaging languages between CRF systems to decrease data inconsistencies caused by flexible entry into EDC systems and ease data integration

Understanding SDTM/ADaM and Protocol/CDASH standards for effective application anticipating the legally enforced CDISC standards

• Uncovering a straightforward strategy to correctly and clearly map data for analysis
• Workflow for Protocol and CDASH to define CRFs and make them ready for database and analysis
• Clarifying how SDTM/ADaM will help data managers and statisticians with data mapping in complex mapping processes
• Using in process controls to monitor data quality based on the analysis ready data sets
• Convincing senior management of the benefits of standardisation to receive a budget for warehouse updates and ease long-term architecture maintenance

Discovering ways in which ODM can be utilised to deliver proven time and cost savings during your study set-up

• Using ODM to build libraries of data elements and dataset standards for re-use across multiple studies
• Dynamically generating study specifications through the ODM
• Automating EDC build for various systems using the ODM
• Facilitating database QC and standards compliance with the ODM

Chairman's summation and close of day 1