Contract Research Organization with 15+ years expertise in Russia, Central and Eastern Europe

FDA/EMEA/GCP compliant clinical trials in all therapeutic areas, phases I-IV

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CRO with 15+ years expertise in Russia, Central and Eastern Europe

FDA/EMEA/GCP compliant clinical trials in all therapeutic areas, phases I-IV

Request a free feasibility

Providing our clients with high-quality clinical development services since 2001

  • 2017 Office opened in Poland
  • 2016 Expansion to Slovak Republic
    Office in Budapest opened
    Russian office successfully passes a regulatory inspection by Russian FHSS
  • 2015 Ukrainian office successfully passes a regulatory inspection by Ukrainian MOH
  • 2012 GCT supports the first Russian government-sponsored pharmaceutical clinical development program
  • 2011 Expansion to Hungary and Czech Republic
  • 2008 FDA inspectors visit GCT facilities in Russia while examining investigative sites participating in a GI Phase III project, with no major findings reported
  • 2007 Offices opened in Ukraine and Romania
  • 2006 Clinical operations office opened in Bulgaria
    GCT becomes the exclusive partner of “The White Nights” international ophthalmology congress
  • 2003 US headquarters opened in Princeton, NJ
  • 2001 First office opened in St.Petersburg, Russia
    GCT initiates first local clinical trial
  • 7 offices
  • 9 ongoing studies
  • 15+ years of experience
  • 50+ audits passed
  • 60+ full-time employees
  • 65+ completed trials
  • 80% repeat busines
  • 400 sq. m. logistics facility

Providing our clients with high-quality clinical development services since 2001

  • 7 offices
  • 9 ongoing studies
  • 15+ years of experience
  • 50+ audits passed
  • 60+ full-time employees
  • 65+ completed trials
  • 80% repeat busines
  • 400 sq. m. logistics facility

A full-service solution for clinical trial sponsors

  • Study start-up
  • Regulatory services
  • Project management
  • Safety, medical monitoring
  • Clinical monitoring
  • Patient recruitment

Locations

Corporate headquarters in Princeton, NJ, USA
Clinical operations throughout CEE region:
Russia, Ukraine, Poland, Hungary, Bulgaria, Romania, Slovakia and Czech Republic

GCT coverage and offices

Locations

Corporate headquarters in Princeton, NJ, USA
Clinical operations throughout CEE region:
Russia, Ukraine, Poland, Hungary, Bulgaria, Romania, Slovakia and Czech Republic

Therapeutic expertise

We are a team of professionals with diverse therapeutic backgrounds pursuing one goal - to smoothly guide biopharmaceutical industry through time, cost and hassle of clinical trials

Neurology and Psychiatry expertise

GCT’s core staff and top-management have Neurology and Psychiatry 20+ years background of managing 40+ trials in the U.S. and throughout Europe. It helps us maintain strong and solid relationships within clinical research community with KOLs and high-recruiting investigative sites in Russia and Eastern Europe.

The quality of clinical research data is proven by the percentage of FDA/EMA approved drugs studied within international clinical trials placed partially in Russia is increasing (from 21% in 2012 to 62% in 2015). In the EMA 2013 report, Russia stays among 5 top-enrolling countries in clinical research worldwide.

We have the experience performing clinical trials for the indications including:

  • Alzheimer’s Disease
  • Epilepsy
  • Multiple Sclerosis
  • Schizophrenia
  • Acute Ischemic Stroke
Request CNS experience, incidence rates and regulatory summary
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Neurology and Psychiatry expertise

We have the experience performing clinical trials for the indications including:

  • Alzheimer’s Disease
  • Epilepsy
  • Multiple Sclerosis
  • Schizophrenia
  • Acute Ischemic Stroke
Request CNS experience

Gastroenterology expertise

Central-Eastern Europe has recently reported an altered pattern in digestive system diseases: while the rise in quality of life has reduced infectious diseases rates, the prevalence of autoimmune diseases has in turn increased – such as Inflammatory Bowel Disease, considered to be a major burden in developed countries. Taking into account the trajectory of morbidity of digestive diseases, the development of new drugs and therapies for treatment is becoming more and more vital.

GCT has extensive experience in planning and implementing Phase I-IV programs for gastroenterology studies across multiple countries and sites. Our team has effectively worked on numerous trials in the following indications:

  • Ulcerative Colitis
  • Crohn’s disease
  • Gastric Intestinal Reflux
  • Duodenal Ulcers
  • Functional intestinal symptoms
  • Constipation
  • Diarrhea
Request Gastroenterology experience, incidence rates and regulatory summary
Requested. Get it now or continue

Gastroenterology expertise

We have the experience performing clinical trials for the indications including:

  • Ulcerative Colitis
  • Crohn’s disease
  • Gastric Intestinal Reflux
  • Duodenal Ulcers
  • Functional intestinal symptoms
  • Constipation
  • Diarrhea
Request Gastroenterology experience

Oncology expertise

Oncology is the second most important cause of mortality in the Eastern European Region, contributing to 11% of the disease burden and around 20% of all deaths. Reported raising cancer incidence stipulates the expansion of clinical trials in the area and currently Russia and Central-Eastern European region are regarded by global pharmaceutical companies to be most important strategic locations for clinical research.

According to the WHO, just around 445 clinical trials of cancer are in progress in Russia, Ukraine, Romania, and Bulgaria annually, therefore these countries still have a lot of unfulfilled recruitment potential. Just Russia by itself has more than 50 cancer centers which run domestic and international clinical trials and can be rightfully considered a primary destination for oncology research.

GCT possesses strong knowledge of the leading institutions and investigators in the area. Over the years we successfully conducted various international clinical studies in indications as:

  • Ovarian Cancer, Fallopian Tube and Primary Peritoneal Cancers
  • Prostate Cancer
  • Metastatic Breast Cancer
  • Small Cell Lung Cancer
  • Advanced Solid Tumors
  • CINV
  • Non-Hodgkin’s lymphoma
Request Oncology experience, incidence rates and regulatory summary
Requested. Get it now or continue

Oncology expertise

We have the experience performing clinical trials for the indications including:

  • Ovarian Cancer, Fallopian Tube and Primary Peritoneal Cancers
  • Prostate Cancer
  • Metastatic Breast Cancer
  • Small Cell Lung Cancer
  • Advanced Solid Tumors
  • CINV
  • Non-Hodgkin’s lymphoma
Request Oncology experience

Ophthalmology expertise

Clinical trials in patients with eye diseases constitute an important part of GCT experience. Close ties to the corresponding community in the region has led us to being an exclusive informational partner for the annual “White Nights” ophthalmology congress, a leading event for more than 2000 local and international ophthalmology professionals. The event provides our team with a unique access to the database of potential investigators, gives an opportunity to stay on top of the industry research trends and maintain relations with the regional KOLs.

Our clients are top-ranked Japanese, European and US pharmaceutical companies, for which we have performed late-stage clinical research in a number of main ophthalmic indications:

  • Diabetic macular edema
  • Age-related macular degeneration
  • Dry eye
  • Cataract surgery
  • Ocular hypertension
  • Open-angle glaucoma
  • Pathologic Myopia
  • Conjunctivitis
Request Ophthalmology experience, incidence rates and regulatory summary
Requested. Get it now or continue

Ophthalmology expertise

We have the experience performing clinical trials for the indications including:

  • Diabetic macular edema
  • Age-related macular degeneration
  • Dry eye
  • Cataract surgery
  • Ocular hypertension
  • Open-angle glaucoma
  • Pathologic Myopia
  • Conjunctivitis
Request Ophthalmology experience

Rare Diseases expertise

Each year more and more attention is drawn to the modern world’s unmet medical needs, many of which represent the field of orphan diseases. Guided by scientific progress and regulatory incentives, biopharmaceutical industry has increased their input to the complex process of orphan drug development.
The most obvious challenge for rare diseases clinical research is the small number of patients available in each indication. A typical orphan drug trial includes multiple sites worldwide, often with just a few patients enrolled at each location. CEE countries and Russia together come close to 300 million people population, making it a geographic area that cannot be ignored within this type of clinical trials.

GCT is proud to offer the opportunities of our region of operations combined with local expertise and unique access to KOLs. Some of our recent projects included work in the following indications:

  • Immune Thrombocytopenic Purpura (ITP)
  • Wegener Granulomatosis
  • Fabry Disease
  • Congenital Fibrinogen Deficiency
  • Atypical hemolytic-uremic syndrome
  • Paroxysmal Nocturnal Hemoglobinuria
Request Rare Diseases experience, incidence rates and regulatory summary
Requested. Get it now or continue

Rare Diseases expertise

We have the experience performing clinical trials for the indications including:

  • Immune Thrombocytopenic Purpura (ITP)
  • Wegener Granulomatosis
  • Fabry Disease
  • Congenital Fibrinogen Deficiency
  • Atypical hemolytic-uremic syndrome
  • Paroxysmal Nocturnal Hemoglobinuria
Request Rare Diseases experience

Reproductive Health expertise

Such medical conditions as ovarian cancer, endometriosis, inflammatory diseases, arterial hypertension, and many others affect women's reproductive health, particularly during pregnancy and childbirth. While it is highly essential to develop new drugs and diagnostics in reproductive endocrinology and infertility, the major players who reached the clinical development stage are facing a number of problems, including ethical issues, lack of experienced investigators and equipped sites.

According to EMA "Cooperation in the field of clinical trials" report, Russia is one of the top-enrolling countries in clinical research worldwide, whereas the quality of data coming from Russia and CEE region compared to Western Europe and US is quite high based on the statistics of recent FDA inspections. Those facts make our region an attractive destination to place clinical studies, especially in the sensitive area of male and female reproductive health.

In years of clinical operations, GCT has gained solid experience in the following indications:

  • Mixed Bacterial Vaginosis
  • Pre-Term Birth
  • Erectile Dysfunction and/or Low Libido
  • Endometriosis
  • Prostate Cancer
  • Ovarian Cancer
  • Fallopian Tube and Primary Peritoneal Cancers
Request Reproductive Health experience, incidence rates and regulatory summary
Requested. Get it now or continue

Reproductive Health expertise

We have the experience performing clinical trials for the indications including:

  • Mixed Bacterial Vaginosis
  • Pre-Term Birth
  • Erectile Dysfunction and/or Low Libido
  • Endometriosis
  • Prostate Cancer
  • Ovarian Cancer
  • Fallopian Tube and Primary Peritoneal Cancers
Request Reproductive Health experience

Extended experience

For more than 15 years GCT has been gaining experience in multiple therapeutic areas to respond the needs of our Sponsors.

We are proud to be established as a CRO of choice by many KOLs and leading medical institutions in various therapeutic areas.

We have the experience performing clinical trials for the therapeutic areas including:

  • Anaesthesiology
  • Dermatology
  • Endocrinology
  • Haemotology
  • Immunology
  • Rheumatology
  • Pediatrics
Request Extended experience, incidence rates and regulatory summary
Requested. Get it now or continue

Extended expertise

We have the experience performing clinical trials for the therapeutic areas including:

  • Anaesthesiology
  • Dermatology
  • Endocrinology
  • Haemotology
  • Immunology
  • Rheumatology
  • Pediatrics
Request Extended experience

Executive management with decades of experience

GCT Management is closely involved in each project that we take charge of and puts into practice personal oversight every step of the way until successful study completion

Jeffrey Apter, MD, President

With 30+ years of executive oversight, management and conducting experience in over 300 clinical trials in Eastern Europe, Russia and USa, 40+ years of practice in Psychiatry and Neurology, and dozens of publications, Dr. Apter has internationally renowned expertise in clinical research.

Being the founding member of numerous professional associations and research institutions, he has the knowledge, authority and enthusiasm to navigate clinical research programs in various regions and therapeutic areas.

Eugene Selivra, MD, CEO

Having received his medical degree from Pavlov Medical School in St. Petersburg, Russia in 1985 and followed by heading a department at the prestigious Bekhterev Psychiatric Institute, making over 10 publications in CNS clinical research, Dr. Selivra has 25+ years of experience conducting and managing multi-therapeutic trials in US, Europe and Russia.

As a recognized expert in CNS field he retains a solid authority within clinical research community in the region.

Schedule a meeting with GCT executives

Executive management with decades of experience

Jeffrey Apter, MD, President

Eugene Selivra, MD, CEO

Schedule a meeting with GCT executives

Business Development team

Meet your first contact with GCT, our Business Development team

Anna Kuzmicheva
BD Director
Russia

Contact Anna

5+ years of experience in clinical trials
10+ years in customer relationship management
Completed multiple ICH/GCP trainings
Executive oversight of commercial agreements
Master of Arts in methodology and teaching of foreign languages and cultures

Natalia Katsnelson
BD Manager
USA

Contact Natalia

3+ years of experience in clinical trials
10+ years in customer relationship management
Completed multiple ICH/GCP trainings
Project budgeting and proposal development
Cross-cultural liaison between Sponsors and regional teams
Public relations specialist

Aleksandr Stiblo
BD Associate
Russia

Contact Aleksandr

3+ years of experience in sales and marketing
Completed multiple ICH/GCP trainings
Project budgeting and proposal development
Business development and partnering opportunities selection
Management specialist

Business Development team

Meet your first contact with GCT, our Business Development team

Anna Kuzmicheva
BD Director
Russia

Contact Anna

Natalia Katsnelson
BD Manager
USA

Contact Natalia

Aleksandr Stiblo
BD Associate
Russia

Contact Aleksandr

Over 60 employees in 9 countries

Meet just some of our team members

Vladimir Seredyuk, MD
QA Director
Global

10+ years in clinical trials
Positive experience with FDA, EMEA, National regulatory inspections

Csilla Leka, MD
Office director, Global PM
CEE

6+ years in Project Management
Experience in various therapeutic areas, CEE regulatory

Veronica Goriachikh
Head of logistics
Russia

Pharmacist/Logistics specialist
Import/export, regulatory, GSP compliance

Irina Golovacheva, MD
RA Manager
Russia

Regulatory in Russia, MoH, EC
100% successful submission track record

Sergiy Nayda, MD
Senior CRA
Ukraine

10+ years of experience in clinical trials
Experience in multiple therapeutic areas

Samer Hilan, MD, PhD
Office director, Global PM
Bulgaria

10+ years of experience in clinical trials
Experience in various therapeutic areas, Bulgarian regulatory

Learn more about our clinical team

Over 60 employees in 9 countries

Meet just some of our team members

Vladimir Seredyuk, MD
QA Director
Global

Csilla Leka, MD
Office director, Global PM
CEE

Veronica Goriachikh
Head of logistics
Russia

Irina Golovacheva, MD
RA Manager
Russia

Sergiy Nayda, MD
Senior CRA
Ukraine

Samer Hilan, MD, PhD
Office director, Global PM
Bulgaria

Learn more about our clinical team

See what our clients and partners say about us

As you have all already know we have completed the patient screening in our study on schedule with total of 710 patients!
This is a huge achievement and would not have been possible without your hard work and contribution and excellent relationship with your investigators.

Clinical Research Manager,
Big Pharma

The management team and the CRAs are physicians, and the lead monitor for our breast cancer trial is an oncologist. The monitoring and reporting of the data are exceptional. The team is extremely responsive to the trial demands and always performs at an optimal level. This is a pleasant change from some of the other CROs we have worked with where the team is not quite as experienced.

Senior Director Clinical Operations,
US Pharma

We are very positive about the performance of GCT. We can summarize as follows: delivery on time of monitoring tasks; well trained staff; low query rate and no major audit findings; very responsive. Additionally we can say that they fully support the study if business-critical demands occur

Global Project Manager,
Global R&D

Request referral letters

See what our clients and partners say about us

We are very positive about the performance of GCT. We can summarize as follows: delivery on time of monitoring tasks; well trained staff; low query rate and no major audit findings; very responsive. Additionally we can say that they fully support the study if business-critical demands occur

Global Project Manager,
Global R&D

Request referral letters

You are one step from making your project a success

  • Over 15 years in business
  • 80% repeat clients
  • Optimal coverage
  • Unique KOL and Site access
  • Strong team
  • True on-the-ground expertise
  • Flexibility

Get in touch

Please take a moment to fill this form. Our representative will contact you soon.





Alternatively, call us at: +1 609 921 6868 (US) or +7 812 703 0008 (Russia),
or email to bd@gctrials.com

Get in touch

Please take a moment to fill this form. Our representative will contact you soon.





Alternatively, call us at: +1 609 921 6868 (US) or +7 812 703 0008 (Russia),
or email to bd@gctrials.com