Rare Disease Project in Russia

A multi-center rare disease Phase 3b clinical trial has been recently awarded to GCT. Managed globally by our long term Spanish CRO partner, the study will be also conducted at 2 clinical sites selected in Russia. New trial is designed to assess the safety and the efficacy of the innovative treatment for rare metabolic condition.

Cardiac Study Expansion in Russia

GCT is happy to announce the expansion of the Phase III Cardiac Surgery Study in Russia. It is an international study aiming to recruit over 1000 patients worldwide. GCT Russian team is managing regulatory, clinical, and logistics part of the trial. Since 2017 and up until now 1 site from Russia was participating in this multi-national trial sponsored by EU Pharma company, now it will be conducted at 5 Russian sites in total.

Database Locked for the Women’s Health Study

We are glad to announce that the database for the Phase III Women’s Health Study was locked on February 4th after 7 years of trial duration. This is a multi-center, randomized, double-blind study conducted in patients with a previous preterm delivery, for its further prevention. GCT is proud to be managing this trial in Russia, Ukraine, Bulgaria, Hungary and Czech Republic, with a total of 1018 patients randomized in our countries.

GCT would like to thank every one of our team members, that worked hard to achieve this milestone!

 

Phase-III Ophthalmic Study is Approved within 44 Working Days

The end of the year was marked for GCT team with yet another achievement. Clinical trial approval was received ahead of official timelines for Phase III study, – the whole review process, including Q/A with competent authority, lasted 44 working days.

A multi-centre, randomized, investigator-masked study is designed to evaluate the investigational drug in patients with ocular hypertension or primary open angle glaucoma – conditions in which the measured eye pressure is consistently greater than normal.

GCT team’s proactive approach during the submission and the review stages led to this rapid result.

End of Enrollment for Phase II UC trial

Enrollment has just been accomplished for a study in patients with moderate to severe Ulcerative Colitis, a global double-blind, placebo-controlled, parallel group multicenter study designed to evaluate the safety profile of the investigational product.

Our team is currently working towards the completion of this challenging and complex study aimed to enhance treatment methods for the patients.

Pictured: Histopathological image showing moderate ulcerative colitis, by CoRus under CC:BY-SA

Happy Holidays!

Annual summary 2018

2018 has come to the end, and we are glad to look back to what was achieved and to share GCT year in the Highlights!

We would like to thank our long-term partners for the credibility, trust and loyalty, and we hope for the new accomplishments together in the coming year!

We thank all GCT employees for the great contributions made this year to the advancement of the global healthcare. Wishing you and your family a Happy New Year!

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New CNS Study Awarded to GCT in USA

A randomized, double-blind, placebo-controlled phase II trial will be conducted at U.S. sites under GCT management. Study design assumes enrollment of patients with mild to moderate Alzheimer’s Disease, randomized in 3 treatment groups.

GCT team is conducting qualification of pre-selected professional Alzheimer’s Research Centers and will be ultimately responsible for crucial study activities, including regulatory support, local project management and monitoring.

Investigator meeting completed for Phase 1-2 study in adult participants with relapsed or refractory PTCL

This month GCT has successfully conducted Investigator’s meeting for the international multicenter Phase 1-2 study in adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL). The study will be conducted across 17 study sites by GCT in the U.S., Russia and Ukraine.

Over 60 participants from Investigator Sites, Sponsor, GCT and Vendors met at Kempinski Hotel Corvinus in Budapest, Hungary to discuss the study design and the standard of care between the different countries, as well as the benefits that trial medication could potentially bring to the patients.

Nataliya Katsnelson will participate in CTFM summit expert panel

The Clinical Trial Financial Management summit takes place in Philadelphia on December 5-6, 2018. Sponsors, CROs, AMCs and sites will discuss the management of financial aspects of clinical trial agreements.

On Thursday, December 6, 2018, Nataliya Katsnelson, GCT Director, Business Development, will participate at the multi-stakeholder panel – Establish Best Practices for CTAs. Nataliya will be representing CRO and sharing best practices used at GCT alongside with the Sponsor and Site representatives that will be speaking on the subject from their perspectives.

Nataliya will also be a facilitator at the closing roundtable discussion later that day (Avoid Change Orders and Anticipate Amendments for the Protocol).

GCT accomplished patient enrollment for a Phase II wAMD program

We are delighted to announce patient recruitment completion for two parallel Phase II Age-Related Macular Degeneration studies in EU.

Across 12 participating sites 56 patients were enrolled in 5 months in two studies.

Majority of the patients have now completed the treatment; the remaining patients will finish trial procedures during upcoming weeks.

With the patient PK samples being analyzed, GCT and Sponsor are working closely towards studies’ completion.

 

Image credit: Ralf Roletschek by CC BY-SA 3.0

GCT signs a contract with US pharma company to conduct global phase I-II trial in patients with Peripheral T-Cell Lymphoma

GCT has been awarded the international multicenter Phase 1-2 study in adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL). The planned study will be conducted across 17 study sites by GCT in the U.S., Russia and Ukraine.

The study is designed to identify and characterize the safety, tolerability, efficacy, and the PK profile of Investigational Product in patients with relapsed or refractory PTCL. Phase 1 will explore multiple dose levels and select a single dose level in Phase 2 to more effectively assess efficacy in the PTCL population.

Consequently, up to approximately 55 participants will be treated in the study as a whole.

GCT has identified and qualified 17 sites across all countries to accomplish enrollment goals. Our regional teams have rapidly initiated start up activities: while working closely with sites on feasibility, qualification and agreements, submission dossier was also completed and submitted to all regulatory authorities review last month.

Image by Paulo Henrique Orlandi Mourao

First patient randomized in an international double-blind Phase III cardiac surgery study

An international double-blind Phase III cardiac surgery study, sponsored by a European biopharmaceutical company and managed by GCT in Russia has got off the ground.  Recently, the leading Russian Cardiology Institute has randomized the first patient in the study.

GCT Russian team is managing regulatory, clinical, and logistics part of the clinical trial.  We are proud to contribute to this pivotal international study aimed at recruiting more than 1000 patients worldwide.

 

 

SWIFT ENROLLMENT COMPLETION FOR A PHASE II STUDY

We are pleased to announce that the enrollment for International Multicenter Phase II study in patients with Non-Hodgkin lymphoma was successfully completed in September. Due to the efficient work of Ukrainian sites, which were included in the study this summer, the required number of participants was randomized within very short period.

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Enrollment launches for Phase II study in patients with Non-Hodgkin lymphoma

An International Multicenter Phase II study in Patients with Non-Hodgkin lymphoma is currently ongoing in 6 countries, including Ukraine that was recently initiated by GCT.

Ukrainian sites were activated and started screening procedures last week, bringing 5 randomized patients and 2 more at screening only a week later! (more…)

Enrollment commences in Phase II Age-Related Macular Degeneration program in EU

GCT has worked closely with the Sponsor on reaching this important milestone and over the past months has secured Regulatory and EC approvals, conducted site initiation visits and managed shipments of required supplies to the sites. We have successfully progressed to the enrollment start on schedule in the two participating countries – Hungary and Poland.

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Approval received by GCT for an international Phase III cardiac surgery study

GCT is delighted to announce that the approval for an international double-blind Phase III cardiac surgery study was granted by the Russian Ministry of Health.

We manage the Russian part of the clinical trial that will be performed by a dedicated team of Investigators at the leading Cardiology Institute. Our team is responsible for regulatory, clinical and drug logistics services.

 

(more…)

GCT announces last patient enrolled in Phase III clinical study in women’s health

GCT study team is proud to announce a huge milestone achievement – the last study subject has been randomized in multinational Phase III clinical study in patients with a previous preterm delivery – the largest obstetrics/gynecology study conducted so far.

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GCT Central-European office relocation

GCT is already managing 5 multicentre clinical trials in Hungary and GCT team is set up for further expansion.

The steady growth has made it necessary to relocate GCT team in Budapest to a larger office.

(more…)

Enrollment is completed in a late-stage anaesthesiology trial

Close-out visits are scheduled to be performed by GCT team in Russia for a Phase III multi-center double-blind anaesthesiology study sponsored by a leading Russian pharmaceutical company. (more…)

GCT initiates a phase II clinical trial in patients with Non-Hodgkin lymphoma in Ukraine

A multi-center phase-II study is currently ongoing in 5 countries.  Last week GCT was awarded a contract to expand the study and include 2 additional sites in Ukraine.

At the moment our Ukrainian office has already submitted study documents to Regulatory Authority. (more…)

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We are a full-service clinical development provider, offering feasibility analysis, regulatory submission, site selection, project management, monitoring, data management, logistics, and more.

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