Archive for September 2024
Complex Spinal Deformities: Medical Imaging in Clinical Trials
Deformities of the spine, in which the spine is abnormally curved or aligned, can often seriously impact mobility, cause debilitating pain and negatively affect a patients overall quality of life. Patients with complex spinal deformities often require continuous pain management, spinal bracing, or in advanced cases, surgical intervention. Deformities of the spine, in which the…
Read MoreWCG’s 2024 Clinical Research Site Challenges Report
This content is password protected. To view it please enter your password below: Password: The post WCG’s 2024 Clinical Research Site Challenges Report appeared first on WCG. Source: Drug Industry Daily
Read MoreFDA Roundup: September 27, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Source: FDA Press Releases
Read MoreCoverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success
Coverage Analysis for Oncology SlidesDownload The post Coverage Analysis for Oncology Trials: Understanding the Nuances and Keys to Success appeared first on WCG. Source: Drug Industry Daily
Read MoreStreamlining Site Feasibility and Start-up: Overcoming Challenges and Embracing Innovation in Clinical Research
In the ever-evolving landscape of clinical research, site feasibility and start-up processes remain critical yet challenging aspects that can significantly impact study timelines, costs, and overall success. In a recent episode of WCG Talks Trials, Michelle Yu, associate director of clinical strategy dove into these challenges with Trevor Cole, director of client delivery, site and…
Read MoreFDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia
FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors. Source: FDA Press Releases
Read MoreCancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators
This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products for the treatment of cancer. Specifically, this guidance includes recommendations for sponsors and/or IRBs regarding the appropriate use of washout periods and concomitant medication exclusions. Quick takeaways for sponsors: Some eligibility…
Read MoreFDA Approves New Drug to Treat Niemann-Pick Disease, Type C
FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg Source: FDA Press Releases
Read MoreFDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
Listen to an audio podcast of the September 12th, 2024 FDA Drug Safety Communication on rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Source: FDA Drug Safety Podcasts
Read MoreBTS Research Successfully Completes USDA Inspection with Zero Findings
BTS Research Successfully Completes USDA Inspection with Zero Findings San Diego, CA — August 28, 2024 — BTS Research, a leading contract research organization specializing in preclinical research services, is proud to announce the successful completion of its USDA inspection with zero findings. The inspection was triggered by the recent acquisition of BTS Research by…
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