PAID MESSAGE - Save to PDF, print, copy, file, repeat. Sound familiar? For those handling and managing the regulatory documentation at clinical research sites, it's a common workflow full of paper and redundancy. Maintaining a Regulatory Binder is a task that hasn't changed much over the years. Stacks of documents, protocols, amendments, IRB approvals, correspondences, […]
With the touch of a few computer keys you can tell the world via platforms like Yelp that a vaunted local brew pub’s seasonal draft is flat, a hotel’s beds are lumpy, and the pricey luggage set you just purchased at a certain upscale department store looks more worn out than you after just a […]
The U.S. Food and Drug Administration (FDA) has unveiled a reorganization of the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER), coupled with corresponding changes in the Office of Translational Sciences and Office of Pharmaceutical Quality. The approved changes in OND will create offices that align interrelated disease areas and […]
Chronic principal investigator (PI) turnover and shortages will continue to hold the clinical trial industry back until we do a better job educating and training vital new entrants, says Christina Brennan, MD, MBA, vice president for clinical research at Northwell Health Feinstein Institute for Medical Research. “It’s a real problem in our industry.” The so-called […]
"Sites are overwhelmed with too many solutions and ballooning login credentials," said Jim Kremidas, executive director, ACRP. "Instead of engaging with patients, an inordinate amount of time is spent learning new systems, completing redundant required training and reentering the same data multiple times. Simultaneously, pharmaceutical companies and CROs are left with a fragmented ecosystem of software, hardware, […]
