Insights Blog

Clinical Site Regulatory Processes: The Case for Standards

Posted by Paul Baechtold on Jun 18, 2018 9:00:00 AM
“Uncontrolled variation is the enemy of quality.” 

-- William Edwards Deming 

The concept of standards is not new.

People throughout time, in all eras, geographies, and industries have looked to create standards as a way to improve efficiency and reduce variance of outcomes.

For instance, King Henry I of England standardized measurement in 1120 AD by instituting the ell, which was equivalent to the length of his arm. Another example is that the Egyptians were the first to develop the 365-day calendar and are often credited with logging 4236 BC as the first year in recorded history. In 2009, a cross-section of life science companies, contract research organizations, technical vendors, industry groups and others established the Trial Master File (TMF) Reference Model to develop a standardized taxonomy and nomenclature for organization of TMF content.

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Topics: eRegulatory, Standardization, Automation

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