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Time To Embrace Paperless Clinical Trials

Wednesday, June 21, 2006

When it comes to efficient drug development, pharmaceutical companies have a lot to learn. Recent research we conducted at CenterWatch suggests, however, that they might just be getting t he message, at least when it comes to clinical trials In a recent survey, we polled users of electronic data capture (EDC) software – the folks on the front line of research who conduct their clinical trials using this software – for their views on the factors most likely to prevent future drug development delays.

Their top answer: EDC software. When we conducted the same survey in 2003, EDC software came in fourth.That’s not to say that the industry has embraced the technology yet – only about 10% of clinical trials are currently done electronically. But the results of our survey certainly show a readiness to embrace an electronic trials process, unsurprising given the immense pressures on pharma companies from the courts, regulators, investors and the public at large. Paper trials, it seems, must end.Two recent quarterly reports from small EDC companies support the idea that biopharma is getting serious about efficient drug development…

Phase Forward and Datatrak both posted solid revenue gains, with Phase Forward showing a 17% jump in third-quarter revenue to $22.2 million and Datatrak growing revenue by 36% to $4.1 million.

EDC companies bear watching for what they say about how pharma is re-engineering the drug development processes around EDC. We all know that developing a new drug is expensive. This software helps when pharma’s clinical research processes are reworked to reflect its adoption. One of the primary benefits for pharma from EDC is being able to make drug safety decisions on quality data early in the development process in real time.

Sure, these companies are small, and there are some hurdles they’ll need to clear to become viable large-scale solutions. Most EDC companies, for example, still don’t offer enterprise-wide solutions. Competition is also fierce among a number of public companies, including eResearchTechnology and soon-to-be public etrials, and small private companies such as Medidata Solutions and Datalabs, not to mention software giant Oracle. That is part of the confusion for pharma. With 20 vendors in this space, there are simply too many choices.

We will be watching investigators and small EDC companies for signs of which biopharma companies are getting their drug development processes right. Because the drug researchers that do may be recording the kinds of profit gains pharma companies posted regularly in the bygone era of blockbuster drugs.

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