FDA Shows No Letup with New Biomarker Guidance

Traditionally, the workplace pace slows as the holiday spirit overtakes us in December. Days are a little less productive. Employees take vacations. It’s a time usually reserved for office parties and long lunches. Tell that to the U.S. Food and Drug Administration (FDA). Yesterday (December 12), the agency released another clinical trial–related guidance—this one providing […]

What Do Sites Really Want from Sponsors and CROs? ACRP/Avoca Survey Explains

The Association of Clinical Research Professionals (ACRP) and The Avoca Group surveyed nearly 300 clinical trial study site staff earlier this year to determine the most important factors for advancing quality in studies from their perspectives. What follows is a conversation about the results with Jim Kremidas of ACRP and Dennis Salotti of The Avoca […]

Revisiting Ethics and Human Subject Safety in Clinical Research

Clinical Researcher—December 2018 (Volume 32, Issue 10) PEER REVIEWED Maribelle Guloy, MSHS, CCRP   Academic institutions have, on occasion, been found to be in gross violation of the norms for ethical conduct of clinical research by subjecting human volunteers to experiments involving untoward risks to their safety and lives. Similarly, pharmaceutical companies have sometimes demonstrated […]