Capgemini Analysis
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Utilizing the Right Levers to Make Clinical Trials More Efficient
By Klaus Nagels
Principal, Global Life Sciences Sector
Capgemini
The latest generation of clinical trials data management systems is paving the way for pharma companies to conduct clinical trials in lower-cost countries while improving decision-making and increasing the quality and transparency of the data. However, it will take more than a classical consulting approach to make this work; it requires organized collaboration.
There are clear financial advantages to conducting trials in countries in Eastern Europe, or in India and China, where the skill levels of clinicians and healthcare staff are high and the cost base is low.
Not only that, but moving clinical trials to these countries offers relief from the bottlenecks that are hitting trials in the West, such as the increasing reluctance of patients to participate, or the highly prescriptive requirements introduced by the EU Clinical Trials Directive that came into effect in May 2004.
These bottlenecks are increasing the amount of time it takes to set up trials and recruit patients in what can be thought of as traditional clinical trials venues. All of these factors can have a serious and direct financial impact - to the extent of a pharma company missing a marketing window.
But while India, China, and Eastern Europe offer clear cost incentives, many pharmaceutical companies do not, as yet, have operations there. This raises the issue of how to manage and control clinical trials at a distance and still capitalize on the advantages of these locations.
Clinical trials management systems have now reached the stage of maturity where they have a real impact on trial efficiency, providing management with direct and potent levers with which to oversee the process from end to end.
Such systems can provide the means to manage clinical trials remotely, enabling pharma companies to take advantage of lower-cost environments without the risk of losing control.
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