Wingspan announces that Actelion Pharmaceuticals, a top 20 biopharmaceutical company, has selected Wingspan eTMF as its official electronic trial master file.
Wingspan announces that Actelion Pharmaceuticals, a top 20 biopharmaceutical company, has selected Wingspan eTMF as its official electronic trial master file. The company, based in Switzerland, outlined specific goals of the trial master file implementation including providing key management metrics, increasing inspection readiness, saving time, reducing costs and increasing eTMF quality. Wingspan eTMF allows Actelion access to comprehensive metrics and reports in real time and integrates with the company’s existing applications. Because Wingspan eTMF is cloud-based, Actelion’s clinical trial specialists will have 24-hour access to trial related documents managed by Wingspan eTMF and easy external access from any location for all users, including CROs and partners.
Additionally, Actelion selected Wingspan given the technology company’s specialized focus on eTMF and strong client references from Pfizer and ICON, plc.
Wingspan Principal and CEO, Troy Deck said, "We are thrilled to have Actelion as a client and extraordinarily excited to be able to support their worldwide research through the use of our eTMF platform. Wingspan’s technical excellence and focus on trial efficiency aligns well with Actelion’s core values of Innovation and Results-Driven approach. Working together, we will continue to shape and improve the TMF landscape through refinement and expansion of our powerful and distinct capabilities."
After signing contractual agreements last week, Wingspan project managers joined the Actelion team in Switzerland to kick-off the implementation project. Wingspan will work with Actelion to launch its pilot project in mid-February with a larger rollout in June.
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.