
FEATURED ARTICLES

When I speak with pharma executives on certain topics, it’s amazing to see the difference in where companies stand in terms of implementation. Adaptive trials is one of those topics. I will talk to one executive who will tell me it is one of the trends that will most impact the pharma industry in the coming year, and then talk to another who will tell me it’s old news and something they have been doing for years. Regardless of where you stand with adoption, one thing is clear: Adaptive trials have many advantages, but are also more complex.
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BMS' Opdivo Trials: What They Teach Us About Successful Studies
It’s hard to ignore the news around immunotherapies to treat cancer. Opdivo is a Bristol-Myers Squibb (BMS) medicine that has been approved by the FDA for patients with previously treated advanced non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. Opdivo also provides a textbook lesson for sponsor companies on how to conduct a successful clinical trial.
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Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20%
Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.
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Source Documents And Data Retention In Drug Safety
In late November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. By Bart Cobert