…sites need to negotiate terms with their sponsor. Unfortunately, many sites aren’t comfortable with the prospect of negotiating a budget – either because they don’t feel confident in their negotiating abilities, or they don’t know the right tools to use for the best leverage. (Forte Research.com)
Data-gathering implantable chips to be tested in schizophrenia trial
Although wearables have yet to establish themselves as a mainstream clinical trial technology, some research teams are already looking to the next big thing: implantables. Pierre Fabre has moved itself to the front of the field by striking a deal to test a chip in a schizophrenia development program. (FierceBiotechIT)
Patient-centric trials to give CROs competitive edge, say sponsors
A more patient-focused approach will expedite clinical trials and responsive CROs will have the competitive advantage, say AstraZeneca, EMD and Bayer. (Outsourcing-Pharma.com)
Learn from Theranos’s mistakes: an analysis of the Form 483s (Part 1)
Startups should heed the Theranos warning: When you raise millions of dollars to develop a product, remember the processes that help get that product to market, including proper implementation of a robust quality management system. (MDDI Online)
U.S. plans to require trial consent publication
The U.S. government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human services (HHS). (Outsourcing-Pharma.com)
Using technologies and innovative methods to conduct Food and Drug administration-
A Q&A on the FDA’s new rare disease drug development guidance
The FDA issued its expected guidance on rare disease drug development in late August, 2015, and public responses are due in October. Behind the scenes is the buzz of collaboration between patient advocacy groups and drug developers as we analyze, exchange thoughts, and prepare our responses to this important document. (Geeks Talk Clinical)
Reform of clinical research regulations, finally
“…Fortunately, in November 2009, while working at the White House Office of management and Budget, I was able to convene representatives of HHS and other departments to develop reforms to enhance participant protections and make the oversight process more efficient. Those meetings led to an Advance Notice of Proposed Rulemaking in 2011 and release of a Notice of Proposed Rulemaking (NRPM) this September. The end of this process is now in sight.” (The New England Journal of Medicine)
Scientists urge national initiative on microbiomes
Scores of leading scientists on Wednesday urged the creation of a major initiative to better understand the microbial communities critical to both human health and every ecosystem. (New York Times online)
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