Monthly Archives : December 2016

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ALCOA. A framework for quality

Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of him. His personal shortcut for tenets of data quality was ALCOA, but when he ran out of space on a slide one day, he included the acronym. After that, it stuck.

THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.

THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.

Some dread it.

Others create it.

Either way, you know it is inevitable.

Change.

The clinical research industry is no exception. Ever since James Lind’s famous scurvy trial in 1747,1 where he demonstrated the affliction could be cured by the consumption of oranges and lemons, the concepts, tenets, and processes of modern clinical research have been evolving. This is no different today, with the global clinical trials market estimated to grow 7.5% annually to approximately $22 billion USD by the year 2021. Of that, medical device clinical trials are expected to contribute about a third, making transformation of the industry unavoidable.

Global politics, shifting regulations, and technological innovations–all big picture drivers of change– influence not only manufacturers of medicines and medical devices, but the consumers of these products as well. Economic factors affect markets, which drive changes to industry directly and indirectly via changes in regulations. Improvements in technology provide an impetus for changes to processes and efficiency.

These are our top predictions of what is in store for the clinical research industry.

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