The Programme

Registration

Opening remarks from the Chair

EXAMINING DATA INTEGRATION ACROSS THE CLINICAL DATA LIFECYCLE

Debating data integration and the e-clinical landscape

• Integrating clinical data – purpose, process and technical implications
• Critical drivers for a solution design
• Conclusions on concepts for e-clinical landscapes

Wyeth case study: Are we gaining the full benefit of 'e' business for clinical research

• What did we plan to achieve by going electronic? What was the value proposition?
• How effective were we? Did we reach our targets?
• What were the enabling factors, how sustainable? And where are we going next?

Clinical trials in the 21st century

• Achieving more with less is the order of the day - two-fold or even four-fold productivity increases are being set as a target for 2009
• What challenges does this introduce and what solutions are we presented with?
• Discussing e-source models, adaptive trial designs, the increasing role of non eCRF data, and the demand for real time data visibility
• Case study - demonstrating the increasing demands and identify the needs of the 21st century

Morning refreshments

ACCELERATING CLINICAL TRIALS WITH EDC

11:10

Monitoring the progress of clinical trials using EDC

• Introducing prerequisites for suitable progress monitoring
• Discussing elements of progress monitoring
• Outlining alerts and communication

EDC - have we been conned?

• Let's be honest – has EDC really delivered the expected gains?
• How have the roles of the trial team actually changed versus what we expected?
• Whatever will they try and sell us next?
• Some questions you might want to ask the software salesman when he stops talking!

Lunch

Ram Kamath
CEO
VSOFT INFOWARE

and

Boris Fainstein
Member
Board of Advisors
VSOFT INFOWARE INC.

Infoware for Adaptive e-clinical trials - a reality

• Silos based approach to pyramid structure approach
• Chaotic delay to disciplined JITs
• People dependent to process dependent
• Distractions to focus
• Localising globalisation

ELECTRONIC TOOLS WITHIN CLINCAL TRIALS

An investigators point of view: Primary care challenges undertaking e-Clinical trials

• An experienced investigators view of the benefits and pitfalls of electronic data capture
• Impact of eCRF on recruitment and incorporating user views in design
• Use of primary care IT systems effectively - coding, data templates, assuring GCP compliance

Is IVR old hat?

• History and current state of IVR functionality in clinical trials
• Extending its application areas
• Using the internet as a modality
• IVR’s role in the full integrated e-clinical context

Afternoon refreshments

Brent Caldwell
Team Leader, Phase I, Medical Data Services
BOEHRINGER INGELHEIM

and

Lesia Tontisakis
Senior Associate Director, Drug Safety Operations
BOEHRINGER INGELHEIM PHARMACEUTICALS INC.

Integration, not reconciliation

• The development of user requirements to plan the integration of the SAE form into RDC, which will replicate nightly to ARISg
• The role of subteams to perform mapping of variables, data validation checks, data derivations, validation plan of the transfer, interface planning, and the SAE case page
• Challenges to overcome

Automatic loading of laboratory data into eCRF - practical experiences

• Why use automatic lab data loading?
• What are the requirements?
• Discussing the features of different systems in use
• Understanding the necessary pre-settings
• Role of CDISC
• Day to day challenges and how to solve them
• Lessons learned

Panel session: Maximising trial efficiency by effectively integrating into one platform

A selection of speakers from throughout the two days will discuss and answer questions on the following topics:

• Discussing challenges of data integration across the clinical data lifecycle
• Sharing, managing, analysing and integrating varied and increasing sources of data
• Debating interoperability between different systems

Closing remarks from the chair

08:30

Registration

09:00

Opening remarks from the Chair

09:10

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of e-clinical trials.

Lunch

To a more open and standardized e-clinical world

• Outlining the market landscape (tools, standards and issues)
• A way to improve this e-clinical world
• Discussing e-clinical and performance metrics
• A modular clinical platform implementation
• Conclusion

Introducing the WHO international clinical trials registry platform (ICTRP)

• Outlining the public registration process
• Discussing the impact of ICMJE
• Presenting WHO ICTRP
• Comparing different public registers and outlining the UK situation

The added value of EHRs - Linking patient care, clinical research & public health

• Setting the scene – definitions, legal, technical, collaboration and penetration of Electronic Health Records (EHR)
• Examples of opportunities and challenges for pharma industry
• Status of EU initiatives, pilots & examples of EHR re-use in EU and US
• The high level recommendations for moving forward & discussion about the opportunities for pharma and health care

The impact of CDISC on e-clinical trials

• Outlining latest developments in CDISC (Clinical Data Interchange Standards Consortium)
• Increasing the efficiency of data management with CDISC and CDASH (Clinical Data Acquisition Standards Harmonization)
• Discussing standardisation and interoperability through CDISC and CDASH

Taking CDISC Standards to the Next Level

• The limitations of GSK's current approach to defining standards
• Aspirations, and how these translate into requirements
• Describe what CDISC is doing to meet these requirements i.e. the development of a populated CDISC Metadata Repository
• Describe how a populated CDISC Metadata Repository will deliver the benefits we all need

EHRCR - a few links added to the healthcare and research chain

• Overview EHRCR functional profile project
• Mapping clinical research requirements to EHRCR user requirements to EHRCR functional profile
• HL7, EurRec and CCHIT status with the project
• Mock assessments of EHRs using the profile
• Next steps on creating more and more links

Closing remarks from the Chair

Close of conference