The hidden costs of eCTD transition.....

Sometimes a lead paragraph is too good not to borrow. Check this one out:

"It's been six months since the Center for Drug Evaluation and Research (CDER) division of FDA started requiring all electronic submissions to use the electronic common technical document (eCTD) format, and all is not well."

That's the take of Virginia Ventura of the FDA according to Bio-IT World. It's to be expected - I think. The technology used to produce eCTD's is new, the compilation and presentation procedures are new too. Anytime a whole lot of people have to change what they do at the same time, problems are a given.

What's the cost of failure?

The costs of a faulty drug submission (which means that drug approval is delayed, which means that the public doesn't get access to therapies that have been developed, studied, and tested, and whose claims of efficacy in treatment or prevention of health problems) are substantial. Stockholders and/or investors lose as well; years and years of time and huge sums of money have been spent on drug deelopment and there's no payoff until the approved product hits the market.

There may be other losers (in the short term) as well. The vendors in the Documentum/SharePoint game. Why do I say this? Because at another time end-users at Life Sciences and Biotech firms would be chomping at the bit to implement MOSS which offers a more elegant integration with the front end Office applications than does Documentum or OpenText.

The good news for companies like EMC/Documentum might be that the bugs in their 21 CFR 11 compliant integrations with SharePoint will have been worked out by the time the eCTD transition headaches are gone. The danger to traditional ECM Life Sciences vendors is that Microsoft will develop a robust-enough compliant solution in the interim.

Comments

[fda clinical trial]

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