Features

eCOA: Keep It Simple, Exec Argues

July 16, 2018

Clinical trials have not yet fully entered the digital age. Despite a revolution in consumer electronics that has built libraries of real-time personal health data, sites and sponsors seem to regard digital technology the same way Saint Augustine prayed for chastity and continence: “Grant them to me, O Lord — but not yet.”

Finding Good Sites in Today’s Competitive Site Landscape

July 9, 2018

The biopharmaceutical industry now spends $500 million on Big Data in the hopes of finding great investigators and streamlining trials — and yet 23 percent of sites never enroll a single patient and 80 percent of all trials are still delayed.

HHS Delays Common Rule Another Six Months and Adopts Three Exceptions

June 25, 2018

In a widely expected move, HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period.