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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…)

GCT Anniversary reception, Philadelphia, June 28, 2016

We would like to thank everybody who came to GCT party to celebrate our 15th anniversary during the DIA meeting last month, and especially our Partners and Clients – without you we wouldn’t be here. Cheers and we look forward to many successful years together! (more…)

Award of a new observational study

This first week of July GCT is pleased to announce a new deal to execute a non-interventional study in the area of preterm birth prevention. The research is to be performed throughout 39 clinical centers across Czech Republic, Hungary, Russia and Ukraine. (more…)

GCT announces services expansion to additional countries

The Danube river in Budapest

The Danube river in Budapest

GCT has established clinical operations in three new countries: Hungary, Czech Republic and Slovakia. In these countries GCT now offers its clients full assistance for clinical trials, including feasibility studies, clinical monitoring, project management, regulatory support.

(more…)

Approval granted by Bulgarian Drug Agency

Bulgarian Drug Agency building in Sofia

Bulgarian Drug Agency building in Sofia

GCT is delighted to announce that we received the approval to conduct a Phase III epilepsy trial in Bulgaria for our long-term partner, a US pharmaceutical company. (more…)

Submissions update

Following the award of a new ulcerative colitis project, GCT regulatory team has performed the documents submission to the Russian Ministry of Health for obtaining the clinical study approval.

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Romania, device trials updates

GCT team in Bucharest has performed the submissions to the NMA and Central Ethics Committee for the approval of a medical device trial in CNS area. (more…)

Happy Holidays!

Christmas market in Sibiu, Transylvania, Romania.

Christmas market in Sibiu, Transylvania, Romania.

As the year draws to a close, GCT would like to thank the ones who made our success possible in 2015 and wish a very happy Holiday Season to all.

May the coming 2016 be filled with joy, happiness, peace and prosperity! (more…)

Last patient screened

Drawing showing lesions in brain stem and spinal cord.

Drawing showing lesions in brain stem and spinal cord.

GCT team is pleased to announce the end of subject screening for a relapsing-remitting multiple sclerosis trial in Russia. (more…)