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25 September 2024 from 4:00PM to 5:30PM (CEST) Webinar Overview It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the […]

Applied Clinical Trials Online ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial intelligence (AI)? Lacroix: There is a lot of opportunity across the life cycle to assist with this and it’s interesting because historically it was always: we want to throw people at some of […]

Fiercebiotech Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years prior to launch. This strategy should focus on addressing the nuanced market access challenges for such treatments, including but not limited to, distribution network design, tailored commercial site engagement, […]

Biopharm International FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, […]