FDA Logo

FDA Awards Grants to Stimulate Rare Diseases Trial Development

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 […]

Doug Schantz, Executive Director, US Site Management and Monitoring, AstraZeneca

AstraZeneca Harnesses Standards to Advance Internal Monitoring Program

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 […]

Ron Waife headshot

Operating Assumptions: The End is the Beginning

“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 […]