More trials. Bigger trials. More technology and services firms supporting each trial. More types of data. More silos. More entrenched egos defending the silos. All of the above should be driving the adoption of the approach of the Clinical Data Interchange Standards Consortium (CDISC). But pockets of resistance to standards remain.…more...

The software that ordinary people prefer is getting simpler. Easier. And it’s increasingly running not on a desktop computer, like Microsoft Word, but online. Last year, the web ratings firm comScore estimated in this Powerpoint deck that, in the U.S., an impressive 78 percent of users had tried a small, internet…more...

First they said it couldn’t be done. Then they said there was no business reason for it to be done. Trouble is, Landen Bain went and did it anyway. As liaison to health care for the Clinical Data Interchange Standards Consortium (CDISC), Bain has been working for four years to tie…more...

Say your institutional review board (IRB) is stumbling, bungling paperwork, taking too long to approve—or not approve—your trial. It’s time to pick a new one, but you’ve had this IRB so long you have no idea how to start looking. There’s not much literature offering a method. But Sue Hocker has…more...

Are traditional software companies dinosaurs? How many of the top 100 firms on this list will be thriving in 2019? Their most dangerous rivals have moved online, using the web, following the path blazed by Salesforce.com. The buzzword is software as a service (SaaS). Adobe, to take one example, said last…more...

The regulatory process in Brazil, previously seen as complicated and convoluted, just got simpler and more logical. The country has been a familiar destination for sponsors for at least a dozen years. It ranks up there with China, India and Russia. But Brazil’s regulatory structure has been slow, rigid, and some…more...

Editor’s note: A friend in Chicago knows someone. That someone was so concerned about this strongly-worded inter-office email from the Obama transition team that they passed it along. It does not represent the thinking of ClinPage, L.L.C. or its staff. Hey Dawg, “Mr. President-Elect” still sounds ... offffficial? Is there a…more...

In recent years, the industry has made massive investments in how it gathers data. Electronic data capture (EDC) and patient diaries have pushed growing amounts of data into digital formats. But what of the other end of the process—where such data emerge for regulatory purposes? To an unfortunate degree, even the…more...

Like the industry it regulates, the FDA finds itself in a slowly closing vise—squeezed between a mission that never seems to get much narrower and a budget that never gets much bigger. So we were interested to hear the comments of Douglas Throckmorton, deputy director in the FDA’s office of the…more...

In the end, clinical development comes down to biostatistics and words—words in the protocol, the study report, the regulatory filings, the drug label. In a global world, getting those words right can be no small matter. “There are a lot of translation companies out there. Only a handful specifically specialize in…more...