PharmaVigilant
, a clinical trial technology provider, has enhanced its InSpire Electronic Data Capture (EDC) system to support multiple languages for the management of even more complex, large-scale global clinical trials. InSpire now supports Italian, Spanish, Portuguese, French, German, Dutch, English, Danish, Swedish, Norwegian, and Icelandic as well as Malay and Swahili languages, with additional languages to be added in a multi-phased approach. These updates allow sponsors to easily build multilingual studies, and support data entry and reporting in any of these languages for easier and more compliant data capture.
PharmaVigilant’s InSpire EDC system addresses the evolving complexities of clinical development by bringing together technologies that support the needs of both the industry and end-users throughout the entire clinical development process. With PharmaVigilant’s integrated approach, InSpire eliminates the need for separate systems and ensures fast study start up and data lock by providing, role-specific work flow tools empowering sites to enter and review data with minimal training. Now available in multiple languages, the system features customized study tabs with real-time information on enrollment, data entry, data monitoring, sign off and data lock.
PharmaVigilant offers a full suite of clinical trial technology offerings including InSpire EDC, I-Warehouse, I-Builder, I-Vault electronic Trial Master File (eTMF), I-Vault remote Source Document Verification (rSDV), study administration and PaySite - an automated site payment system. PharmaVigilant focuses on Phase I-IV clinical trials, registries and other post-marketing studies. The technology has supported more than 200,000 patients in 14 countries across North America, South America, Europe, Asia and Australia.
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.