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.

 

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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.

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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…)

New study for non-invasive device for coronary stents

An innovative medical device company appointed GCT to perform clinical trials for the state registration of a non-invasive device for coronary stents. GCT is proud to be a part of the team which will bring this cutting-edge technology on the market. For the successful conduct of clinical trial in the future we are initially providing Sponsor with the vital segment of clinical research – medical writing services. (more…)

GCT Enhances Its Presence In EE With The Addition of Clinical Operations In Moldova

Growing steadily, GCT has extended its network and strong coverage of the EE region by establishing clinical operations in the Republic of Moldova.

We now offer full support for clinical trials in Moldova, including feasibility, clinical monitoring, project and site management, and regulatory services.

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GCT is one of the most promising clinical trial solutions providers in India

Source: https://healthcare.siliconindiamagazine.com/ranking/10-most-promising-clinical-trial-solutions-providers-2018-rid-292.html

Silicon India Healthcare Magazine has put GCT in the top 10 most promising clinical trial solutions providers-2018 in India.

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GCT Announces the valuable addition to its U.S. Clinical Operations Team

As of the beginning of 2018 GCT has appointed Michael Wamil, J.D., M.S., as Director of Clinical Operations, U.S., to lead and expand the company’s therapeutic and service portfolio. (more…)

Eastern European Investigators’ Meeting held in Budapest, Hungary

GCT is proud to be conducting the extensive international Phase III clinical study in women’s health. Our full-time in-house teams are responsible for the enrollment of over 1,000 patients in CEE region including Ukraine, Russia, Hungary, Czech Republic and Bulgaria. (more…)

Hungarian Regulatory Approval Received for Diabetic Macular Edema Study

We are proud to announce that Global Clinical Trials (GCT) has gained EC and RA approval last week in Hungary for the ongoing ophthalmology project. This approval allows GCT to continue to demonstrate its well-established knowledge and experience in conducting clinical trials across various ophthalmic indications. The clinical sites in Hungary are part of a large multinational, phase II diabetic macular edema clinical study being conducted within the European Union. (more…)

GCT warehouse has successfully passed the annual internal audit

Today Vladimir Seredyuk, MD, Quality Assurance Director conducted internal on-site audit of GCT warehousing facility in Saint-Petersburg, Russia. We are happy to announce that no major findings were revealed. (more…)

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GCT is a CRO experienced in performing clinical research in the USA, Europe, Russia and India.

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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