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Approval received by GCT for an international Phase III cardiac surgery study

GCT is delighted to announce that the approval for an international double-blind Phase III cardiac surgery study was granted by the Russian Ministry of Health.

We manage the Russian part of the clinical trial that will be performed by a dedicated team of Investigators at the leading Cardiology Institute. Our team is responsible for regulatory, clinical and drug logistics services.

 

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GCT announces last patient enrolled in Phase III clinical study in women’s health

GCT study team is proud to announce a huge milestone achievement – the last study subject has been randomized in multinational Phase III clinical study in patients with a previous preterm delivery – the largest obstetrics/gynecology study conducted so far.

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GCT Central-European office relocation

GCT is already managing 5 multicentre clinical trials in Hungary and GCT team is set up for further expansion.

The steady growth has made it necessary to relocate GCT team in Budapest to a larger office.

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Enrollment is completed in a late-stage anaesthesiology trial

Close-out visits are scheduled to be performed by GCT team in Russia for a Phase III multi-center double-blind anaesthesiology study sponsored by a leading Russian pharmaceutical company. (more…)

GCT initiates a phase II clinical trial in patients with Non-Hodgkin lymphoma in Ukraine

A multi-center phase-II study is currently ongoing in 5 countries.  Last week GCT was awarded a contract to expand the study and include 2 additional sites in Ukraine.

At the moment our Ukrainian office has already submitted study documents to Regulatory Authority. (more…)

New study for non-invasive device for coronary stents

An innovative medical device company appointed GCT to perform clinical trials for the state registration of a non-invasive device for coronary stents. GCT is proud to be a part of the team which will bring this cutting-edge technology on the market. For the successful conduct of clinical trial in the future we are initially providing Sponsor with the vital segment of clinical research – medical writing services. (more…)

GCT Enhances Its Presence In EE With The Addition of Clinical Operations In Moldova

Growing steadily, GCT has extended its network and strong coverage of the EE region by establishing clinical operations in the Republic of Moldova.

We now offer full support for clinical trials in Moldova, including feasibility, clinical monitoring, project and site management, and regulatory services.

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GCT is one of the most promising clinical trial solutions providers in India

Source: https://healthcare.siliconindiamagazine.com/ranking/10-most-promising-clinical-trial-solutions-providers-2018-rid-292.html

Silicon India Healthcare Magazine has put GCT in the top 10 most promising clinical trial solutions providers-2018 in India.

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GCT Announces the valuable addition to its U.S. Clinical Operations Team

As of the beginning of 2018 GCT has appointed Michael Wamil, J.D., M.S., as Director of Clinical Operations, U.S., to lead and expand the company’s therapeutic and service portfolio. (more…)

Eastern European Investigators’ Meeting held in Budapest, Hungary

GCT is proud to be conducting the extensive international Phase III clinical study in women’s health. Our full-time in-house teams are responsible for the enrollment of over 1,000 patients in CEE region including Ukraine, Russia, Hungary, Czech Republic and Bulgaria. (more…)

Hungarian Regulatory Approval Received for Diabetic Macular Edema Study

We are proud to announce that Global Clinical Trials (GCT) has gained EC and RA approval last week in Hungary for the ongoing ophthalmology project. This approval allows GCT to continue to demonstrate its well-established knowledge and experience in conducting clinical trials across various ophthalmic indications. The clinical sites in Hungary are part of a large multinational, phase II diabetic macular edema clinical study being conducted within the European Union. (more…)

GCT warehouse has successfully passed the annual internal audit

Today Vladimir Seredyuk, MD, Quality Assurance Director conducted internal on-site audit of GCT warehousing facility in Saint-Petersburg, Russia. We are happy to announce that no major findings were revealed. (more…)

Happy New Year 2018!

GCT team in 2017

As the year draws to a close, GCT team would like to take the opportunity to thank you, loyal supporters, for your continued dedication to experiencing the real difference with our high-quality clinical trials. GCT continues to expand in 2017 and has currently local offices across 10 countries in Central and Eastern Europe, Russia and India.

We always listen and appreciate your feedback and will certainly implement all the comments you made, as we believe that there is always a room for improvement.

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GCT welcomes Margita Tothova, MD, Senior CRA in Hungary

Dr. Tothova has joined the GCT team this September as a Senior CRA based out of our Hungarian office. Margita is a Medical Doctor with over a decade of experience in the clinical trials industry. After graduation from the Comenius University of Bratislava Margita started her medical career from working as a pediatrist at the General Hospital of Komarno. A few years later she joined one of the biggest pharmaceutical companies as their local representative.  Once Dr. Tothova entered the world of clinical trials, she continued to gain valuable experience and soon became a countries lead for Slovakia, Hungary and Czech Republic.

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GCT receives a sky-scraping score by Dun & Bradstreet Rating

GCT was recently rated based on the business credit information by the world’s most credible and comprehensive source of commercial data.

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Diabetic foot ulcer study award in Europe

We are proud to announce that GCT was selected as the contractor by the Polish Pharma company in connection with their participation in the Operational Program Intelligent Development 2014-2020, which is organized by the National Center for Research and Development in Poland.

During the tender, GCT has gained the highest score based on the strict selection criteria. It is always a goal for us to meet the requirements of our Sponsors and we look forward to start yet another successful collaboration.

A randomized multicenter controlled Phase IIa clinical trial on a novel pharmaceutical topical gel for wound healing will be performed by GCT in several European countries with participation of 15 clinical sites. (more…)

Approval is granted for invasive medical device study in Slovak Republic

We are delighted to announce that both EC and RA approvals to conduct clinical trial in Benign Prostatic Hyperplasia patients were received by GCT team earlier this week. We are preparing for the site initiation in order to start screening and enrollment procedures in November.

Benign Prostatic Hyperplasia is the non-cancerous enlargement of the prostate, affecting about 50% of men above 60 years of age and more than 70% of men ages 70 and above. Please contact us at bd@gctrials.com to navigate through the clinical, regulatory and logistical aspects of conducting device and pharmaceutical trials in Slovakia and other EU countries. (more…)

GCT team is launching two phase II ophthalmology studies in EU

In September GCT was awarded a program of wAMD in Europe. Two studies will be conducted to investigate therapeutic effects and safety of a treatment regimen in patients with wet form of Age-related macular degeneration.

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GCT names Tatiana Fedorova, MD, PhD a Head of Clinical Department 

 

Dr. Fedorova has joined GCT team this July as a Head of the Clinical Department in Russia. She has a unique combination of training and higher education in medical field, research and pedagogy. She is an MD, PhD, MPH, ASSC PROF and has more than 20 years of direct clinical trial experience at the country and on a global level.

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GCT team welcomes new medical device registration project

 

Inventive medical device company granted GCT a many-sided task of diversified consulting and comprehensive regulatory support in obtaining license for their revolutionary product to be marketed in Russia. (more…)