Tools for Clinical Trials Professionals
Package integrates smoothly into existing business enterprise software formats
Fast Track Systems Inc. (Conshohocken, PA) has a new enterprise solution for advancing the clinical development process. According to Fast Track Systems, TrialSpace Designer improves quality by ensuring protocol consistency and accuracy, and eliminates operational ambiguities at the trial design stage.
The solution is tailored to a life science company's specific therapeutic areas to adhere to individual corporate processes, SOPs, and standard text, plus it incorporates existing Word templates. With TrialSpace Designer, clinical trial professionals have access to indication-specific industry benchmark data on procedures and costs from the company's proprietary databases. Fast Track Systems says that the package delivers better operational efficiency with faster trial startup and completion and reduces avoidable operational costs. Among other benefits are quicker and cleaner trial summations for regulatory submissions and shorter trial timelines.
TrialSpace Designer
Fast Track Systems Inc., (215) 358-1400, www.fast-track.com
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
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.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.