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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

GCT to provide regulatory support for Novel Wet Age-related Macular Degeneration Treatment

GCT has been awarded a new regulatory project — an ophthalmological study for a Korean biotechnology company.

A novel wet age-related macular degeneration (Wet-AMD) treatment is to be investigated. The sponsor has requested GCT to provide the regulatory support services for the IND application prior to the clinical trials.

GCT’s regulatory group will perform the necessary activities to file the IND and proceed with required clinical trials in US and globally.

June 8, 2021

Approval for Endometriosis study in Ukraine obtained

Global Clinical Trials has been recently awarded to run a new project in Women’s Health. The goal of the study is to assess the efficacy and safety of the Investigational Product (IP) for the treatment of endometriosis in women of reproductive age.

On March 23rd, 2021, the State Expert Centre of MOH of Ukraine has issued approval to begin the enrollment.

April 6, 2021

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Upcoming meetings

CPhI North America

Hybrid / Pennsylvania Convention Center
Philadelphia, Pennsylvania
2021, July 26 — August 12

World Orphan Drug Congress USA 2021

Gaylord National Harbor Hotel,
Oxon Hill, Maryland
2021, August 25—27

Advanced Therapies Congress and Expo 2021

ExCel,
London, United Kingdom
2021, October 5—6

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About

GCT is a CRO experienced in performing clinical research in the USA, Europe, Russia and India.

We are a full-service clinical development provider, offering feasibility analysis, regulatory submission, site selection, project management, monitoring, data management, logistics, and more.

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