David Vulcano headshot

Advanced Communication Skills Help Sponsors, CROs Attract Best Sites

Sponsors and contract research organizations (CROs) hoping to stand out in the crowd and attract the "best of the best" sites would be well advised to keep the lines of communication wide open before, during, and after a clinical trial. “Some studies have provided us with FAQ spreadsheets--the spreadsheets where they track questions regarding the […]

Brent Sorrells, Director of Clinical Operations, Allako

6 Tips for FDA Inspection Prep

It can be the professional equivalent of sitting in your dentist’s waiting room the morning of your root canal surgery. Whether it’s unannounced or you received some notice, U.S. Food and Drug Administration (FDA) inspections can be unnerving experiences for clinical trial sponsors, to say the least. However, there are tools and tactics you can employ […]

In New Survey, Nearly 60% of Clinical Researchers Blame Data Management Hurdles for Trial Delays

Clinical Trial Data Snafus Attract Unwanted FDA Attention

Persistent clinical trial data management problems are slowing trials, sparking U.S. Food and Drug Administration (FDA) audit findings and 483s, and putting patients at risk. That’s the grim assessment of clinical researchers in a new survey report from Oracle Health Sciences and Pharma Intelligence. Nearly 60% of clinical researchers said data management hurdles had delayed […]

Jeff Kingsley headshot

Sponsors and Sites Must Find New Ways to Collaborate

There’s too much “us” versus “them” dividing sites and sponsors as they conduct clinical trials—and patients suffer the consequences, several thought leaders said during a panel discussion at the Veeva 2018 R&D Summit in Philadelphia last month. “There should be more focus on the patient as driving us to one common vision,” said Dawn Fury, […]

FDA Commissioner Scott Gottlieb, MD

FDA Encourages Innovative Clinical Trial Design to Fight High Drug Prices

Two new guidances from the U.S. Food and Drug Administration (FDA) demonstrate the agency’s increasing attempts to inspire clinical trial innovations and the use of advanced trial techniques to help drive down drug costs and bolster consumer choice. A 36-page draft guidance on adaptive design replaces a 2010 document and is broad in scope. A […]