Blog
Tufts releases report on causes of drug development failures
On September 10, 2013, the Tufts Center for the Study of Drug Development released a report concerning the leading causes of failures in drug development. Based on a study of products that entered clinical development from 2000 through 2009, the study found that Phase...
FDA issues final guidance on risk-based clinical trial monitoring
The final FDA guidance entitled "Guidance for Industry Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring," issued early August is similar to the draft guidance published in 2011. FDA encourages risk based remote monitoring, electronic tracking...
FDA issues new Guidance for IRBs, Clinical Investigators and Sponsors – August 27, 2013
FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing...
Psoriasis patients providing insights and driving research
Check out this intriguing article by Noe Baker in www.biotech-now.org about a new community called Citizen Pscientists. Formed by the Psoriasis Foundation, their hope is to create a community "who are helping impact the future of psoriatic disease research." By...
American Chemical Society national meeting features Gretchen Bowker, COO
Gretchen Miller Bowker, Pearl IRB COO, will be a featured speaker at the ACS annual meeting. The conference will be held September 8 - 12th, 2013. To register and see the full agenda, click here. Date/time: September 9th, 9:45 - 11am...