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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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New cardiac surgery study is awarded to GCT

 
An innovative European pharmaceutical company appointed GCT for management of its international multi-center double-blind Phase III study in Russia.
According to the research made by the Sponsor, there are currently no drugs on the market that have been shown to reduce the risk of postoperative complications for patients undergoing invasive cardiac surgery. Therefore, if previously collected data is proved by this clinical trial, its implications will go far beyond the realm of cardiac surgery for patients, the community and pharma business.

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RRMS study close-out meeting

GCT is proud to announce that Phase II clinical trial was successfully completed!
Last week Dr. Eugene Selivra, CEO, and Dr. Alexey Vinogradov, Project Manager, participated in the investigator meeting in Sochi, Russia devoted to the successful Phase II Multiple Sclerosis project completion. During the formal part of the meeting an overview of promising study results was given by the Sponsor and a dynamic discussion on the future application of the study drug took place. After the official part was over, all participants proceeded to a lavish gala-dinner organized by the Sponsor to celebrate the project success. Informal and very animated conversations continued, revolving around current standards of care, breakthrough therapies and market potential for the studied product.

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GCT team completes project training with MAPI Group

As the start-up stage of an observational infant study is actively progressing, our multinational study team has attended a project-specific training held in Budapest by our colleagues from MAPI Group. GCT clinical department members from Russia, Ukraine and Hungary gathered to hold discussions on protocol-specific questions, study timelines and milestones overview, and a round table on enrollment strategies and investigator motivation tools.

The study is a follow up to an international Phase III clinical study in pre-term delivery which GCT is responsible for in CEE countries. The Sponsor for both projects has been our long-term partner, awarding studies to GCT since 2004. We believe this to be a perfect demonstration of the high quality of our work which maintains the trust of our clients for years and makes 80% of our business repeat.

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Relapsing-Remitting Multiple Sclerosis (RRMS) study completion

GCT Russian team has performed all close-out visits for a double-blind multicenter placebo-controlled study of treatment naïve patients with relapsing-remitting multiple sclerosis. This Phase II study was conducted in Russia with participation of 21 sites which enrolled 227 subjects within 9 months.

For this project GCT provided a full cycle of services: project management, clinical monitoring, regulatory support, drug supply management, local safety reporting, site contracting and payments, central laboratory oversight, data management and statistical analysis.

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GCT is awarded new anaesthesiology study

A leading Russian pharmaceutical company appointed GCT as the CRO of choice for managing their government-sponsored program aimed at bringing a generic inhalational anaesthetic to the local market.

This Phase III multi-center double-blind study is to be conducted in patients undergoing abdominal surgery and is currently in final stages of the Ministry of Health review. (more…)

First patients in IBD trial

GCT announces first subjects screened in the Russian part of a multinational ulcerative colitis trial. Locally, the study is conducted in 6 investigative sites on behalf of a US Sponsor developing an innovative biologic product to treat this debilitating condition. (more…)

GCT Russian office successfully went through a routine inspection by Roszdravnadzor

Today we are very glad to announce that no major findings were revealed during the comprehensive audit by Roszdravnadzor – subordinate to the Ministry of Health of the Russian Federation. (more…)

Happy New Year 2017 from GCT Team!

2016 has been a remarkable year for our company: we started our own operations in Hungary, Slovakia and Czech Republic, celebrated our 15th anniversary, and made valuable additions to our team. We want to express our gratitude to everyone who made that happen – thank you and let us continue our valuable partnerships!

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GCT randomizes first patient into Phase III Women’s health study in Bulgaria

First two patients were screened last week and one already has been randomized to participate in a global multicentre study which is managed by GCT in Central-Eastern European region. (more…)

GCT President made presentations at International Drug Discovery Science & Technology Conference

Dr. Jeffrey Apter gave a talk on «Outsourcing Clinical Trials in Central-Eastern Europe and Russia with local CRO» during the BIT’s 14th Annual Congress last month in Nanjing, China.
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GCT hosts Investigators meeting for the gastroenterology trial in Russia

GCT training

The final part of the meeting: investigators receiving a refresher GCP training

This month GCT has conducted the IM for our long-time US Pharma Client in St. Petersburg. Following the green light received from the Ministry of Health and this successful gathering of Investigators, CRO team and Sponsor representatives, we are now on track with the subsequent study activities. (more…)

GCT receives approval for ulcerative colitis project in Russia

GCT is pleased to announce that the approval for a Phase II UC clinical trial was granted by the Russian Ministry of Health. The Investigator meeting will take place first week of October to gather all parties involved in the trial for a thorough training on the protocol and specific study procedures. (more…)