eShowcase: WebSDM
Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process
Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process
Phase Forward (Waltham, MA) announces a new submission checking service based on its Web Submission Data Manager (WebSDM) application. The hosted service offering produces a comprehensive report detailing all errors identified by WebSDM. Following the report, Phase Forward's CDISC specialists conduct an interactive review session using the customer's data and the same review capabilities that FDA uses.
WebSDM gives organizations a way to test FDA submissions for compliance with the CDISC Study Data Tabulation Model (SDTM) standard for human clinical trials. The Submission Checking System makes WebSDM data validation services broadly available as a hosted service, which enables organizations to quickly confirm if the data from trials conforms to SDTM standards to reduce possible delays from FDA data-related queries.
The service is available now, and current customers can convert to a license for ongoing studies.
Phase Forward, (781) 890-7878, www.phaseforward.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.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
