Celerion Expands Early Phase Clinical Pharmacology Units

Pimicotinib, an investigational colony stimulating factor-1 receptor inhibitor being developed by Abbisko Therapeutics and licensed by Merck KGaA, met MANEUVER’s primary endpoint of objective response rate.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

Five- and eight-year trial data to be presented at ASCO demonstrate durable survival outcomes with Xtandi (enzalutamide) plus ADT, reinforcing its role as a frontline standard in metastatic hormone-sensitive prostate cancer.