What is an eClinical program?

December 11, 2005

Many companies start up “eClinical” projects. But what is eClinical – and how does it support the R&D strategy?

Many companies start up "eClinical" projects. But what is eClinical - and how does it support the R&D strategy? According to industry thought-leaders, defining it as EDC or ePRO misses the point. The break-through benefits lie in taking a holistic approach to the "R&D IT System": re-engineering R&D through coordinated development of the systems portfolio.

An eClinical program is a coordinated portfolio of projects, each with the purpose of optimising R&D processes, supported by IT systems such as: Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Clinical Data Management System (CDMS), Clinical Data Warehouse (CDW), Safety System, Product Supply, Interactive Voice Response System (IVRS), and Resource and Portfolio Management System.

These systems are typical components in a big pharmaceutical company's R&D systems landscape. By looking at this portfolio of systems they can all be considered components of a larger system, the "R&D IT System", supporting different parts of the processes being used in R&D.

In order to maximise the benefits that can be had by the amount of money the organization can afford to spend on IT, an overview of all these systems has to be established and their development coordinated. This gives the basis for assessing what specific benefits each component can give, and thereby the allocation of project funds.

On 7 February 2006, at NNIT's eClinical Conference in Copenhagen, this topic will be explored further by thought-leaders from AstraZeneca, Novo Nordisk, Bristol-Myers Squibb, Bayer, Serono, H. Lundbeck, Solvay and Merck & Co. Mail apb@nnit.com to take part.

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