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July 14, 2017
Inventive device, designed to provide permanent relief of the obstructions in patients with prostatic enlargement, will be tested in Slovakia. GCT is eager to apply and deepen our expertise in managing Urology and Medical Devices clinical trials in EU.
Benign prostatic hyperplasia (BPH) is a common condition in men 50 years and older that can be clinically observed as lower-urinary tract symptoms. There are several treatment options that include pharmacotherapy, minimally invasive therapies and surgery. The gold standard for surgical intervention has been transurethral resection of the prostate (TURP), but in recent years, as technology emerges, men tend to choose those less invasive options with fewer side-effects and morbidity. The new investigative prostate retraction device is intended to reduce most of the known side effects and complications caused by the usage of urethral stents.
July 07, 2017
This week our QA team has got an audit certificate issued by Formalis confirming that GCT systems and processes were successfully audited in relation to Phase III study. The 2-day audit took place at GCT Russian office in Saint-Petersburg in November 2016. We are proud to share yet another proof of the high quality work GCT does.
June 29, 2017
Another new project from an EU Sponsor is in start-up stage at GCT Romanian office. Earlier this month GCT has participated in a kick-off meeting, involving Sponsor team, their investors and leading Bucharest oncologists. Currently a regulatory package is in preparation with study submissions scheduled for August.
The project will investigate an innovative radiopharmaceutical agent and enroll patients with inoperable liver cancers non-responding to standard therapy. It will allow GCT to demonstrate our expertise in oncology clinical research, strengthen the ties within the local investigator community, and provide therapy access to patients with no conventional treatment options.