Advarra is set to acquire Forte in a bid to expand its offerings to include an integrated suite of standards-based trial management products and services – a platform for ‘an interconnected clinical research ecosystem,’ says CEO.
As CROs (contract research organizations) and sponsors look to shave off time from their clinical trial start-up phase, which is where delays occur most frequently, companies may want to look away from local IRBs (institutional review boards), an expert...
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.
Calls for a comprehensive reform of the system of Institutional Review Boards to protect patients in clinical trials have been voiced at a hearing of the House Subcommittee on Oversight and Investigations in the US.