TFS Trial Form Support International (TFS; Lund, Sweden) and Karolinska University Hospital, based in Stockholm, have extended their public-private partnership until 2016 and expanded the early clinical research facilities at the hospital's Karolinska Trial Alliance (KTA). An additional 16 beds have been added to the research unit, which mainly conducts microdosing, first-in-man (FIM), and proof of concept studies as well as PET imaging studies.
“With a total number of 30 beds, we now have extended our capacity which means that we can shorten timelines for certain studies by running more studies in parallel," said Eva Lundqvist, MSc, ML, Director Academic Alliances at TFS, in a company press release. "The expanded facility is a fully state-of-the-art equipped FIM research unit and has been designed so that it suits all different types of early clinical development studies."
With the additional space (850 square meters) and beds, TFS reports that KTA now has the largest Phase I unit in Northern Europe.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.