David Vulcano

Opinion: What Do the U.S. Election Results Mean to the Clinical Trials Industry?

Undoubtedly, the actions and inactions of the U.S. Congress have direct and indirect effects on the clinical trials industry. Also undoubtedly, anxiety is heightened at times after elections, especially when they result in changes of the administration. Times like these result in the struggle between those on their way out having last-minute opportunities to complete or build […]

Ron Waife headshot

Operating Assumptions: Visiting the Urgency Room

One of my friends in the biotech industry explained the business with this metaphor: Working in biotech was like running full speed at a brick wall, and at the last possible second, the brick wall would disappear, only to be replaced by another brick wall farther ahead.

Those brick walls, of course, represented […]

Building an Internal Quality Assurance Program: From the Ground Up

Central to the principles of Good Clinical Practice (GCP) are steps taken to protect human subjects' rights and safety, as well as to ensure the validity and accuracy of data generated from clinical trials to support regulatory submissions.In this light, any academic medical center (AMC) nurturing a research program must implement reasonable measures to safeguard […]

Risk-Based Monitoring: Changing Roles, Changing Mindsets

The adoption of any new concept or technology in organizations is generally slow and usually meets with some resistance from the intended end-users. Some of the issues with adoption of new technologies are the users' comfort level (mindset), the time needed to make changes, the costs involved, the strength of the proof of value/concept presented […]