Wingspan Offers eTMF Readiness Assessment
Wingspan Technology now offers an eTMF Readiness Assessment program to help sponsors and CROs assess their level of readiness for implementing eTMF.
Wingspan Technology now offers an eTMF Readiness Assessment program to help sponsors and CROs assess their level of readiness for implementing eTMF. Completion of the Readiness Assessment will help organizations to learn about best practices, identify gaps, plan resource needs, and move towards risk-based decision making. The assessment can be tailored to best support an organization based on its size, previous experience, partnering approach, and more.
The process begins with a workshop that focuses on reviewing lessons learned from relevant case studies and discussing key elements of eTMF readiness with a cross-functional team. Wingspan’s experts facilitate the discussion, emphasizing the impact that decisions made in early project phases will have in optimizing processes, increasing efficiency and decreasing regulatory risk. The organization then completes a detailed questionnaire covering 11 key aspects of eTMF readiness. Wingspan analyzes the responses and produces a report interpreting the results, benchmarking the organization against industry wherever possible, and provides recommendations for areas of emphasis and return on investment.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
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.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
