Multisystem Rare Disease Study in India
Global Clinical Trials, LLC is initiating a new project in India. It is a Natural History Study of a rare congenital disease to be conducted at several clinical sites across the country.
GCT will provide clinical trial solutions for the study including the project management activities, site management activities, full regulatory support and clinical monitoring.
May 21, 2020
Sponsor Audits Passed Successfully
This year GCT successfully passed 2 Sponsor audits. They were performed by independent auditors employed by the sponsor companies.
From GCT side both audits were led by GCT QA expert and director – Vladimir Seredyuk, MD. Audits included review of project-specific topics, the company’s general procedures, capabilities, and the organizational structure. Neither audit yielded any critical or major findings.
May 5, 2020
Regulatory Approval Granted for Chronic Pancreatitis Study in Russia
GCT has successfully obtained Regulatory Approval in Russia for a multinational Phase II randomized double-blind Gastroenterology study. The official approval from the Russian Ministry of Health (MoH) was received on March 20, 2020.
The GCT team is fully operational and continues to support our clients without interruption, despite the COVID-19 pandemic.
April 15, 2020
Enrollment Commences for Phase II Ophthalmology Trial in Europe
GCT is conducting a Phase II multi-center, double-blind, placebo-controlled dose-ranging study in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in Poland, Hungary and Germany.
April 10, 2020
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Upcoming meetings
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DIA 2020
Walter E. Washington Convention Center
Washington, DC, USA
2020, June 14-18 -
CPhI North America
Pennsylvania Convention Center
Philadelphia, PA, USA
2020, September 09—11
