GCT Opens New Warehouse Facility
GCT has just opened a new, GMP, GDP, FDA, EMA, and Russian national regulations compliant pharmaceutical warehouse in St. Petersburg, Russia.
It has passed a thorough state inspection and received a license to store registered drugs and medicinal products.
December 10, 2021
RA Approval for Breast Cancer Study Received
Global Clinical Trials is managing a Phase I clinical study in Breast Cancer.
The project has recently been approved by the Russian Ministry of Health. This is the first drug created based on the modified oncogenic virus. Pre-clinical studies have shown that the Investigational Product is successful at eliminating cancer cells. The scientists have reason to believe it can also identify and target metastases.
December 9, 2021
Flu Vaccine Trial in Pregnant Women Awarded
GCT has been awarded a multicenter flu vaccine clinical trial in Russia. It will be carried out with participation of approximately 500 pregnant women at screening, and with a follow-up extension to babies.
GCT possesses previous experience in conducting multinational studies in pregnant women with participation of 1000+ subject.
November 10, 2021
GCT to Manage Bioequivalence Study in Healthy Volunteers
Last week, GCT has been selected to conduct a bioequivalence clinical trial in a calcium channel blocker, Manidipine.
GCT will manage the full-service study support including medical writing, clinical and medical monitoring, regulatory, project management, site and vendor management, data management and biostatistics.
November 9, 2021
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
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