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
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.