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.
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
July 29th 2025The application is backed by Phase III AMPLIFY trial results showing the oral combination significantly improved progression-free survival versus chemoimmunotherapy in previously untreated chronic lymphocytic leukemia.
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.
J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data
July 29th 2025The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.