GCT passed Sponsor Audit with no findings
GCT has recently passed a sponsor audit in St. Petersburg, Russia.
The sponsor company is one of the leading vaccine developers with a rapid clinical pipeline. The remote audit was conducted in order to confirm GCT’s adherence to GCP, the Declaration of Helsinki, the Rules of proper clinical practice of the Eurasian Economic Union, the local Russian regulations, and the sponsor’s policies. No major findings were identified. Following the audit, GCT was approved as a vendor of category “A” and authorized to participate in the sponsor’s commercial tenders.
September 28, 2021
GCT to Manage Phase III COVID-19 Study
Global Clinical Trials is adding yet another COVID-19 clinical trial to its Infectious Disease portfolio. As a part of a multi-national project, GCT will manage the double-blind Phase III study in adult patients with COVID-19 in Russia.
After a thorough feasibility analysis, GCT clinical team together with the Sponsor selected the clinical sites with the most enrollment potential.
August 30, 2021
End of Enrollment for the Sore Throat Trial
The enrollment was completed for a phase IV, multicenter, randomized, non-inferiority trial by reaching the study-wide goal of including 360 patients.
GCT is responsible for managing project in Russia where the patient enrolment began in August 2020.
July 29, 2021
First Patient in Idiopathic Pulmonary Fibrosis Study
The first patient has been included in this clinical trial in Russia. The study is a Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy of IP aiming to help those suffering from IPF.
Idiopathic pulmonary fibrosis is a chronic, progressive lung disease. When it occurs, scar tissue (fibrosis) is accumulated in the lungs, making it very difficult for the lungs to transport oxygen efficiently into the bloodstream.
July 13, 2021
GCT to Participate in a New Global COVID-19 Study
GCT has just been awarded a new clinical study related to SARS-CoV-2.
It is a double-blind, randomized, placebo-controlled, phase II study in hospitalized patients infected with severe acute respiratory syndrome-coronavirus-2. The Sponsor is a Swiss Biotech. For this study, 150 patients will be enrolled at the Russian sites.
July 28, 2021
First Patient In Endometriosis Clinical Trial in Ukraine
Global Clinical Trials announces the first successful screening in the endometriosis study.
It is a Phase III double-blind, three-arm superiority study in 200+ subjects that is being conducted in Ukraine. The study aims to assess the safety and efficacy of the Investigational Product (IP) for treatment of endometriosis in women of reproductive age.
July 6, 2021
GCT Celebrates 20 Years of Successfully Managing Clinical Trials
Global Clinical Trials, LLC (“GCT”) is a premier contract research organization providing clinical services in the U.S., Europe, and Asia.
The company is delighted to announce the celebration of 20 years helping small and large pharma, biotech and medical device companies run their clinical studies.
In the following months, GCT will be publishing media content, including the stories of GCT employees and empirical lessons that contributed most to the growth of the company and its service offerings.
June 23, 2021
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