SGS Increases Capacity for Human Challenge Studies
In collaboration with University Hospital Antwerp, SGS is building a new unit with a total capacity of 110 beds. This also includes a separate quarantine unit with 45 beds for CHIM studies. The move to the new unit is planned in mid-2021.
Annick Van Riel, Director Clinical Pharmacology Unit, SGS, said, "Challenge studies will continue to play a key role in the development of medicines and vaccines against infectious diseases in the future. These studies can be a crucial time saving in the clinical development of anti-viral drugs, among other things, by demonstrating efficiency and safety in a controlled environment in a fast and safe manner. That's why we've also decided to invest further in expanding our quarantine capacity in our new CPU. This will allow us to carry out more efficient and faster studies with large numbers of study participants."
Read the full release, here.
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.
