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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 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.

Please contact our BD department to obtain detailed and personalized information on the list of services of GCP/FDA compliant warehousing in Russia.




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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…)

First patient is randomized in a late-stage anaesthesiology trial

Phase III multi-center double-blind anaesthesiology study outsourced to GCT by a leading Russian pharmaceutical company gets off the ground within the projected timelines.

Following screening procedures and randomization, first subject successfully underwent a complicated abdominal surgery,  with the use of an inhalational anesthesia this Monday.  Patient feels well now, and GCT team was happy to contribute to his fast recovery.

The study is being conducted at two investigative sites in Russia each aiming to enroll 60 subjects within the aggressive timelines.

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GCT Announces New Office in Mumbai, India

GCT local office in Mumbai operating under the name “GCT Pharma Research (India) Pvt Ltd” (GCT-India for short) will assist global pharmaceutical companies in performing clinical trials in India. GCT-India will also support the local biopharma community willing to conduct clinical research within CEE countries and Russia, thus helping them to market their products in that attractive region.

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GCT expands clinical operations to Poland

 

Following the direction set last year when GCT established clinical operations in three new countries – Hungary, Czech Republic, and Slovakia, – in May 2017 the company moved further into Central Europe and opened an office in Warsaw, Poland. GCT presently offers its clients full assistance for clinical trials conduct in Poland, including feasibility studies, clinical monitoring, study management, and regulatory support.

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Strengthening GCT ophthalmic experience

GCT team in Budapest has started training for the newest ophthalmic project which we were recently awarded by our long-term partners. The study is an EU multinational Phase II clinical trial involving patients with diabetic macular edema.

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Benign Prostatic Hyperplasia study award

Inventive device, designed to provide permanent relief of the obstructions in patients with prostatic enlargement, will be tested in Slovakia. GCT is eager to apply and deepen our expertise in managing Urology and Medical Devices clinical trials in EU.

Benign prostatic hyperplasia (BPH) is a common condition in men 50 years and older that can be clinically observed as lower-urinary tract symptoms. There are several treatment options that include pharmacotherapy, minimally invasive therapies and surgery. The gold standard for surgical intervention has been transurethral resection of the prostate (TURP), but in recent years, as technology emerges, men tend to choose those less invasive options with fewer side-effects and morbidity. The new investigative prostate retraction device is intended to reduce most of the known side effects and complications caused by the usage of urethral stents. (more…)

GCT successfully passed another audit

This week our QA team has got an audit certificate issued by Formalis confirming that GCT systems and processes were successfully audited in relation to Phase III study. The 2-day audit took place at GCT Russian office in Saint-Petersburg in November 2016. We are proud to share yet another proof of the high quality work GCT does. (more…)

Oncology project launch

Another new project from an EU Sponsor is in start-up stage at GCT Romanian office. Earlier this month GCT has participated in a kick-off meeting, involving Sponsor team, their investors and leading Bucharest oncologists. Currently a regulatory package is in preparation with study submissions scheduled for August.

The project will investigate an innovative radiopharmaceutical agent and enroll patients with inoperable liver cancers non-responding to standard therapy.  It will allow GCT to demonstrate our expertise in oncology clinical research, strengthen the ties within the local investigator community, and provide therapy access to patients with no conventional treatment options.

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