Collaboration is the key to improving the clinical trial process

Last month at Partnerships in Clinical Trials (PCT) in Barcelona, Spain, TransCelerate Biopharma CEO, Dalvir Gill explained to contract research and pharma industry representatives that working together to fix issues is the key to simplifying and expediting the...

Industry responds to FDA’s informed consent draft guidance

In response to FDA’s recent draft guidance on informed consent, industry affiliates such as the Association of Clinical Research Organizations (ACRO) and the Dana Farber Cancer Institute have provided detailed feedback in anticipation of the final guidance....

The issue of dual enrollment in clinical trials

The frequency of dual enrollment, in which participants enroll in multiple clinical trials at the same time in order to benefit from increased healthcare or payments, is up for debate among the Association of Clinical Research Organizations (ACRO) and industry...

Research organizations question FDA draft guidance on IRBs

In November 2012, the FDA published a draft guidance, entitled “IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed,” which outlines recommendations for the...