News

The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Outlining the three concerns communicated the most when it comes to implementing an FSP outsourcing strategy.

Clinical research sites feel growing pressure to perform work in a compliant manner while keeping pace with stakeholder information exchange workstreams, but lack the consistent processes to do so.

ICH E6-R2 has taken another leap forward as quality-focused personnel have shifted focus to vendor oversight plans, essential document management, and evaluating quality tolerance limits in more depth.