PRA Opens Office in Romania
PRA recently opened a new office in Bucharest, Romania to further strengthen its coverage of the Balkan region’s burgeoning markets. The Bucharest office will also support projects in the neighboring Republic of Moldova.
Since 2006, when PRA began conducting clinical trials in Romania, the PRA staff has steadily increased and now includes both product registration and early phase professionals. The number of studies initiated by PRA in this region has more than doubled over the last two years.
“By being based in the Balkan region’s key business and life sciences hub, the Bucharest staff has convenient access to top universities, academic research sites, and most of the country’s major hospitals,” said Ludger Langer, PRA’s Vice President of Clinical Operations in Europe, Asia-Pacific and Africa.
The Bucharest location is the 12th office PRA has opened worldwide since 2009, demonstrating its commitment to meeting its clients’ diverse needs in a dynamic clinical trials environment.
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.
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.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
