Meet us at the events

Pick an event to arrange a meeting:

  1. DIA 52nd Annual Meeting

    Pennsylvania Convention Center

    Pennsylvania Convention Center,
    booth #2427
    Philadelphia, PA, USA
    2016, June 26—30

  2. AAIC Annual Conference

    Miami

    Metro Toronto Convention Center
    Toronto, Canada
    2016, July 24—28

  3. CTIP USA 2016

    Miami


    Miami, FL, USA
    2016, July 28—29

Contact us

+1 609 921 6868 US
+7 812 703 0008 Russia
info@gctrials.com

More contact info here.

Anniversary highlights

We are proud to announce that this year our company turns 15! We are grateful to everyone who helped us get there: our clients, partners and employees.

To celebrate this accomplishment, throughout the year we will feature 15 publications devoted to our team members. Our success is due to their day-to-day contribution and effort. Thank you, GCT team, and keep up the good work!

Vladimir Seredyuk Meet GCT team
Vladimir Seredyuk, MD, Quality Assurance Manager

Dr. Seredyuk has joined GCT QA team in 2014. Vladimir is a licensed physician with 10 years of experience in different areas of clinical research. Following the award of his medical degree in the Medical-Military Academy n.a. S.M. Kirov in St.-Petersburg, Vladimir has accomplished a special course of English at Defence Language Institute and then an Officer Basic Course at US Army Medical Center & School in San Antonio, Texas. After a few years he decided to start a career in clinical research and became CRA for one of the Eastern European CROs. Holding different positions, Vladimir has successfully passed a number of EMEA and FDA inspections and completed the auditing course to become a QA professional.

Vladimir is currently in charge of overseeing all components of the quality process related to clinical trials that GCT conducts. During his time with the company, Vladimir has improved the existing and added new standard operating procedures for trial execution and overall company operations, provided regular trainings on ICH GCP and study specific trainings; he is closely involved in investigator and site pre-assessments and selection process for all projects. He has just the set of skills that are highly valuable in the compound process of clinical research: he is ready to multitask, reacts rapidly towards finding the solution to any situation, is creative and determined yet carefully contemplating the consequences. Dr. Seredyuk is not only carrying out internal audits for company’s trials, but is also engaged as an independent auditor by Sponsor companies to inspect the work of other CROs and sites. Whenever necessary, Vladimir is able to provide Project Management support to GCT clinical team due to the experience in wide range of therapeutic areas, including the company’s core areas of Neurology, Oncology and Gastroenterology.

“GCT is a dedicated team of professionals whose mission is raising the quality of life for people by providing access to new medicines and therapeutic options via conducting clinical trials in the regions of Eastern Europe and Russia. I am very happy to be a part of our team and to be able to help improve my colleagues’ performance by staff training and assurance of highest quality standards of their job on each level”.

Vladimir is multilingual; he speaks Ukrainian, Russian, English, Esperanto and knows some German. He likes to spend free time with family, playing and exploring new places with his 13 years old daughter and 4 years old son. He is keen on active sports such as mountaineering, while after a good hike entertains his friends and family by singing and playing guitar next to the fire under the stellar sky.

Continue to GCT team members:
Nataliya Katsnelson
Sergiy Nayda
Roxana Darie
Velislav Zarev
Anton Romanov
Alina Mitrofanenko

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June 3rd 2016
St. Petersburg, Russia

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GCT announces services expansion to additional countries

Budapest

The Danube river in Budapest

GCT announces expansion of clinical research services into additional European countries.

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.

CEE region is known in the biopharma sector as an advantageous destination to place clinical trials. Compliant and motivated patient population, highly skilled and trained investigators, centralized healthcare system – all these factors contribute to fast patient enrollment and steady retention rates. Combined with the short regulatory timeline, they constitute the reasons to use the opportunities this region offers.

By spreading the geographical coverage, GCT gains the position to offer its clients a more extensive range of services and utilize all benefits of the region.

Dr. Eugene Selivra, Chief Executive Officer of GCT stated: "The expansion of GCT operations to Hungary, Czech Republic and Slovakia will allow us to increase our capabilities in key areas that align with current and future growth plans. These Central European countries are a perfect addition to our existing locations in both cultural and operational sense. We feel that this step will strengthen our ability to deliver high-quality clinical development services to our existing and new Sponsors.”

Ms. Csilla Leka, MSc. has been appointed by GCT executives to provide oversight and management of clinical operations in Hungary, Czech Republic and Slovakia. Csilla will be based in Budapest office. She joins GCT with 6-year experience as project leader in a European CRO, having accumulated the knowledge of on-site monitoring activities, financial and management aspects of clinical trials.

June 10th 2016
Princeton, NJ, USA

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Approval granted by Bulgarian Drug Agency

Bulgarian Drug Agency

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.

The task was completed in just 50 working days.

April 14th 2016
Sofia, Bulgaria

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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.

April 14th 2016
Moscow, Russia

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Romania: device trial 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.

Four investigative sites have already been selected to participate in this advanced project.

Following the highly positive results of the qualification visits to Romanian sites, the Sponsor increased the number of involved institutions up to eight.

February 29th 2016
Bucharest, Romania

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Happy Holidays!

Christmas market in Sibiu, Transylvania, Romania.

Christmas market in Sibiu, Transylvania.

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!

December 25th 2015
St. Petersburg, Russia

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Last patient screened

Drawing showing lesions in multiple sclerosis 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.

In total 243 patients were screened by 21 participating sites in 9-month period.

December 4th 2015
St. Petersburg, Russia

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Milestone achieved for Global Anti-Epileptic program

We are happy to congratulate first site-participant of epilepsy trial opened in Russia last month under GCT management. It officially launches the enrollment for the Phase III multinational study in patients with drug-resistant partial-onset seizures.

December 3rd 2015
St. Petersburg, Russia

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BIT’s IDDST congress on Innovation Driving R&D

GCT President Dr. Jeffrey T. Apter has attended an Annual Congress of International Drug Discovery Science and Technology in Beijing October 20-22, where he presented on “Outsourcing Clinical Trials in Eastern Europe with Regional CROs” business track.

November 8th 2015
Princeton, NJ, USA

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Forum and Technology Show Open Innovations 2015

Panel

"The cradle of futuristic medicine" showcase

The Open Innovations Forum, one of the largest events in Russia, this year was held in Moscow in the end of October and focused on future technologies in the modern human society, economy and everyday life.

GCT CEO Dr. Eugene Selivra was invited to present the CRO segment as a part of the showcase "The cradle of futuristic medicine: biomedical startup infrastructure" during the Health section.

November 1st 2015
Moscow, Russia

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Regulatory inspection in Ukraine

Ministry of health building in Kiev

Ministry of Health building in Kiev

GCT is proud to announce that our Ukrainian team has successfully passed an audit on September 9th, 2015 in Kyiv office.

The audit was conducted by the State Expert Center of Ministry of Health of Ukraine and resulted in no findings, confirming GCT compliance with local laws, as well as ICH GCP standards.

September 28th 2015
Kiev, Ukraine

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State-of-the-art device for patients with ischemic stroke

As a part of the multinational clinical trial, an innovative device for ischemic stroke patients will be tested under GCT management in Russia and Romania.

GCT and Sponsor have jointly conducted a series of site qualification visits during the past two months.

As a result, a number of competent sites were selected to participate in the project and our teams are currently preparing for the regulatory submissions.

September 27th 2015
St. Petersburg, Russia

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Women's health trial expansion

Belgrade University Medical School

Belgrade University Medical School

Phase IIIb preterm delivery study expands to additional locations in Serbia, Romania, and Bulgaria under GCT management, making our team responsible for this project at 45 sites in 7 countries.

The Sponsor, a US pharmaceutical company, thus shows confidence in GCT international capabilities and local expertise.

August 28th 2015
Belgrade, Serbia

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Alzheimer’s disease: therapy updates

The article on the latest therapeutic breakthroughs in Alzheimer’s disease research by GCT President Dr. Jeffrey T. Apter was published in Geriatric Psychiatry report last month.

The paper provides an overview of current trends in AD clinical trials and analyses data on promising drugs that can prevent the formulation of amyloid-a-beta and tau protein.

August 5th 2015
Princeton, NJ, USA

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Completion of the enrollment

Alexandrovska

Alexandrovska Medical University Hospital in Sofia.

GCT team is proud of yet another achievement in the CNS therapeutic area — recruitment of 150 patients in 19 sites in Russia and Bulgaria for the Phase IIb multicenter epilepsy trial was successfully completed this month.

July 31st 2015
Sofia, Bulgaria

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Multiple Sclerosis study: 50% of patients goal reached

An important milestone was reached for the RRMS Phase II study.

GCT has randomized half of the required patients on time, thus maintaining the project schedule.

July 30th 2015
St. Petersburg, Russia

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Regulatory approval granted

GCT received the clinical trial approval for a new Phase III epilepsy project in Russia only 7 weeks after submission.

The regulatory and clinical teams' efficient work and experience contributed to the fast turn-around.

July 29th 2015
Moscow, Russia

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Enrollment completed for the Phase III rare bleeding disorder study

Last month GCT completed the recruitment in Russia for an EMA controlled global trial in orphan disease.

Now the 5 year treatment phase has been started.

June 26th 2015
St. Petersburg, Russia

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New CNS achievements

Bekhterev Institute

St. Petersburg Bekhterev Psychoneurological Research Institute

Enrollment complete

A US biopharmaceutical company announced the completion of patient enrollment in its two pivotal Phase III clinical trials in schizophrenia.

Each of these multinational trials enrolled more than 750 patients whereas GCT team provided medical science liaison services.

GCT is proud to be a part of this progress as the key consultant for Sponsor in Russia and Ukraine.

Regulatory submission

Regulatory submission has been completed for an open-label epilepsy study in Russia earlier this month.

June 24th 2015
St. Petersburg, Russia

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Annual Ophthalmology Congress

OCWN

White Nights XXI attracted over 2000 Ophthalmology professionals from 18 countries.

Traditionally GCT acted as the exclusive information partner of the XXI Ophthalmology Congress “White Nights”, which was held in Saint Petersburg from 25th till 29th of May.

GCT has increased its investigators’ database, maintained existing Sponsor contacts and established new connections within the ophthalmology community.

May 29th 2015
St. Petersburg, Russia

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Gastrointestinal disorders study: enrollment completed

GCT is excited to announce the end of enrollment in Russia and Ukraine for the clinical study in patients with functional intestinal disorders.

336 subjects within 21 participating clinical sites have completed treatment with the investigational drug.

May 28th 2015
Kiev, Ukraine

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Oncology project continues in Ukraine

Dnipropetrovsk City Oncology Center

Dnipropetrovsk City Oncology Center

After GCT team in Ukraine successfully completed an oncology trial in patients with ovarian cancer, Sponsor is willing to proceed with the study continuation.

GCT is now in the process of preparing the documents to submit to the country regulatory authorities.

April 29th 2015
Kiev, Ukraine

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New epilepsy study

GCT is excited to announce the award of a new Phase III epilepsy study to be conducted in Russia and Bulgaria, as a part of Global Anti-Epileptic program.

April 29th 2015
Sofia, Bulgaria

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CPhI Russia participation

CPHI

Dr. Selivra (left) making his speech at CPhI & IPhEB meeting

This week Moscow hosted the annual CPhI and IPhEB meeting, where GCT CEO Dr. Eugene Selivra gave a presentation as an invited speaker at the «Harmonization of standards and requirements for clinical studies and pharmaceutical product registration within the Eurasian Economic Union» session.

April 29th 2015
Moscow, Russia

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Bulgarian sites begin recruitment

Pirogov

Pirogov Hospital in Sofia

 

In March GCT started patient enrollment for the epilepsy study in Bulgaria. All the sites are now activated and enrolled their first patients.

March 31st 2015
Sofia, Bulgaria

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Site audits in Eastern Europe

GCT has been requested to conduct several site audits in Bulgaria, Romania and Ukraine for the ongoing trial by US-based pharmaceutical company.

GCT QA personnel is currently in the field inspecting the sites.

March 27th 2015
Sofia, Bulgaria

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Start of enrollment in MS trial

GCT hosted an Investigator Meeting for the multiple sclerosis clinical trial in the beginning of February in St. Petersburg.

Clinical sites' teams had the opportunity to freshen up protocol details and discuss potential issues with the Sponsor and GCT representatives.

Patient enrollment for the study has been initiated immediately after the meeting.

February 23rd 2015
St. Petersburg, Russia

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Previous postings

Older postings are in the archive

RAI Convention Centre,
Amsterdam