The Food and Drug Administration (FDA) just doled out $22 million over the next four years in the form of 15 new clinical trial research grants designed to spur development of new produces for patients with rare diseases. “Given the often small number of patients facing certain rare diseases, there can be limited resources devoted […]
AstraZeneca (AZ) leveraged a robust standards program to help bring its clinical trial monitoring force in-house—speeding the process and helping to get it right the first time, says Doug Schantz, Executive Director, US Site Management and Monitoring. “We decided to use competencies proactively, rather than applying them reactively,” he explains. A year ago, AZ didn’t […]
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 […]
