Wingspan Technology released eTMF 2.1 on August 29.
Wingspan Technology released eTMF 2.1 on August 29, featuring integrated scanning capabilities which eliminate the need for manual upload or indexing. The release builds upon eTMF 2.0, a major update released in April 2014 featuring a commercial-style user interface (UI) and user dashboards.
Wingspan eTMF 2.1 provides a streamlined process for high volume scanning of TMF documents by providing printable transmittals that are then attached to documents for scanning. The eTMF uses information from the transmittals to automatically attach metadata to the scanned documents. Once scanned, documents and metadata are released directly into a final Quality Control process in the eTMF, eliminating the need for manual upload or document indexing and metadata assignment. The eTMF scanning integration works with both Captiva InputAccel and Kofax scanning solutions. “Although organizations strive to create as many TMF documents as possible as electronic originals, scanned documents still account for 10 to 40 percent of eTMF content,” said Troy Deck, Wingspan CEO. “We have heard of clients incurring costs of up to six dollars per document in uploading and finalizingscanned content. Using our integration, that cost can be reduced to pennies.”
Wingspan eTMF 2.1 builds on Wingspan’s innovative eTMF 2.0 release. Designed to be more intuitive for end users, eTMF 2.0 features a commercial-style UI modelled on sites such as Amazon and eBay. The new UI allows users to locate documents quickly and minimizes training burden – especially important for health authority inspectors using the system hands-on. Personalized user dashboards provide unparalleled insight and transparency into status and health of ongoing trials and allow users to drill down into potential problem areas to learn more. eTMF 2.0 also includes unique features such as study lock and archive and TMF export.
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.