Premier Research and InSilicoTrials have partnered to create safer, faster, and more efficient pathways to regulatory approval for rare disease treatments.
As part of the R&D lifecycle, in silico trials enable simulated synthetic control or treatment arms, inform strategies for patient enrollment, and more efficiently predict the safety and efficacy of novel drugs and medical devices. Synthetic control arms generated using in silico CM&S techniques represent a tool for enabling preclinical and clinical research that otherwise might not be feasible, particularly in rare disease research.
The partnership between Premier Research and Italy-based InSilicoTrials will emphasize smarter in silico study design resulting in more effective pre-clinical review of trial design parameters and faster submission-ready studies.
Premier Research and InSilicoTrials Partner to Leverage In Silico Modeling and Simulation and Optimize Regulatory Pathways for Rare Disease Therapies. (2023, March 13). Cision PR Newswire.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.