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Editor's Note: Bracket is a company focusing on clinical research data services and technology based in Wayne, Pa. Q: There are many initiatives to make clinical research more efficient through technology. What initiatives are you most excited about? A: My move to Bracket has allowed me to strategically shift gears as an innovator. I am […]
“Begin with the end in mind” is one of those classic business phrases which is no less valuable for the number of times it is ignored. Clinical research sponsors are guilty of often fatal forgetfulness of this key concept when planning the development, implementation, and use of new software applications or major organizational change. Clinical […]
I admit it. Over the span of more than 20 years as a clinical research professional, I have become what I affectionately refer to as a “Regulatory Geek.” While I learned the criticality of compliance with regulatory requirements early in my career as a research monitor, my appreciation and understanding of the concept evolved as […]
The more things change, the more they stay the same. Three years ago, I wrote a column for the Clinical Researcher titled “Global Regulatory Insights: Why Do We Have Regulatory Compliance Professionals?” Three years later, the U.S. Food and Drug Administration (FDA) has become more open and communicative, and regulatory bodies are acknowledging that change […]