Ugly Numbers
Massive Job Loss Ahead
Ruminations on the unknown dimension of job cuts in clinical trials and the broad pharmaceutical industry
Last week’s 2012 Post-Approval Summit had one theme in common with the events of prior years. It’s the flip side to the rising importance of patient registries and observational Phase IV studies. Like it or not, there is diminishing faith in randomized clinical trials (RCT) on the part of the industry and regulatory agencies. So what greets the majority of untold tens of billions of dollars in industry-sponsored R&D is basically a ... shrug. A sigh. At least at the Harvard-located event last week, there was a triumphant trumpet blast to meet the small slice of science that happens after drugs are on the market. All of the speakers at the 2012 Summit were in agreement. They concurred that industry will be reliant on some combination of traditional RCT, registries and healthcare databases. MediGuard Update Quintiles supplied a textbook example of the value of a good database. Quintiles acquired the conference's…more...
Are there truly singular contract research organizations (CRO)? Or are CROs interchangeable, like airlines? It's not an academic question in an era when drug, biotechnology and device firms are offloading large…more...
So far, the contract research organization (CRO) industry has been in an enviable place. The fortunes of most CROs have been healthy despite the ailing dynamics of the economy and the…more...
Is giving away electronic data capture (EDC) a viable strategy? Yes. Even as the top suppliers of EDC get even larger, some of the smaller providers are still prospering. A case in point is Akaza Research, which created the free OpenClinica solution and prospers by selling additional services and support. This week, the company released a new…more...
It's a great debate, and far from over. Some analysts predict the large contract research organizations (CRO) will eventually manage the bulk of industry-sponsored research. Others predict that mid-tier and specialty CROs will command a greater share of clinical trials as the giants struggle to take care of small customers as well as they pamper megaclients. Or…more...
Have contract research organizations (CRO) turned the corner? Is the current downturn about to pass? Those were the questions we put to Michael Martorelli, director, Fairmount Partners. Martorelli is a savvy Philadelphia-based observer of the CRO industry. By constitution, he is a plain-speaking and numbers-oriented guy who helps to find buyers and sellers for CROs; his firm…more...
Les Rose appreciates the complexity of calculating costs in clinical trials. Principal of PharmaVision Consulting, a small consulting firm, he has been helping to run trials for a few decades, both independently and at his own small contract research organization (CRO). Rose says sponsors have learned to be tolerant of delay, indulgent of budget overruns. "Lateness is…more...
Ruminations on the unknown dimension of job cuts in clinical trials and the broad pharmaceutical industry
A demo of ClearTrial software and an exploration of the roots of tolerance for imprecision.
Jules Mitchel discusses the lack of any rationale for 100 percent source document verification
Should pharma still be modeling a key R&D process on the construction industry?
An executive from Merge tries to reset industry expectations for radiology-related trials in the age of the internet.
The company discusses what makes Phase IV projects different.
The big CRO discusses a proactive and data-driven approach to managing trials.
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