In a bid to ease the administrative burden on the scientists who run clinical trials, J&J’s Janssen Research & Development is today unveiling a global initiative to standardize and share key information that drug companies require to vet clinical trial sites and ensure they meet industry requirements.
The effort is part of a broader attempt to accelerate drug development that ten of the world’s largest pharmaceutical companies recently disclosed. Streamlining clinical trials is considered one of the first steps.
Janssen R&D, based in Raritan, NJ, says it has established an “Investigator Databank” that is intended to serve as a repository for data about clinical trial sites. Merck and Eli Lilly have joined the project, and have been working with Janssen to ensure that information scientists submit to the database also will satisfy their requirements for prequalifying clinical trial sites.
No patient data will be stored in the database. DrugDev.org, an independent organization with expertise in clinical trial information technology, will host the Investigator Databank. Over time, Janssen R&D says
Author: Bruce V. Bigelow
In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here.
Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University.
Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.
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