Insights Blog

Paul Baechtold

Paul Baechtold works with clinical research sites and institutions to maximize workflow efficiency and compliance. As a continual learner and business development professional, he is passionate about education and making meaningful connections with colleagues across many industries and from different backgrounds to challenge the status quo.
Find me on:

Recent Posts

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.

Read More

Topics: eRegulatory, Standardization, Automation

Subscribe to Email Updates

Recent Posts

About Complion

Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

Contact Us