Investigator Meetings recently held by GCT in Europe

Two investigators meetings were organized to support the start-up of the projects awarded to GCT. The first one took place in Warsaw, Poland, and gathered over 20 sites from 3 European countries for the Phase II Ophthalmology study discussion.

The second was organized in Saint-Petersburg, Russia in early October, and was devoted to the training of sites personnel involved in the pediatric Phase III trial in patients with a rare neurological disorder.

Both studies are in the active start-up.

Approval Received for Clinical Study in Romania

This month, an approval was granted by Romanian National Agency for Medicines and Medical Devices to conduct the study in patients with inoperable liver cancers non-responding to standard therapy. Promising research is being carried out by GCT team in Romania and sponsored by a EU based company. The patient enrollment is expected to start shortly following the Investigator Meeting in Bucharest.

GCT has an extensive Oncology expertise in EU, Russia, Ukraine and USA, and this project is another opportunity for the company to enhance it.

Pictured: Monument of Rebirth in front of the MOH building in Bucharest, Romania, image courtesy by Dennis Jarvis under CC BY-SA 2.0

New office in Hungary

GCT Hungarian team had their first day working at the new office yesterday. Due to the continuous growth in operations and the number of employees, GCT decided to move to a larger, more comfortable facility.

Our new location is:

Fehérvári út 44.,
1113 Budapest

Congratulations to our colleagues in Hungary, and hope you are enjoying the new place!

 

MOH approval received for Rare Genetic Disorder study in Russia

The regulatory approval to conduct CNS Pediatric study in Russia was received by GCT in under 60 days.

This Phase III study in children and young adults with a rare genetic mutation in the X-chromosome was awarded to GCT earlier this year. Study aims to recruit up to 20 patients with this rare and debilitating disease in Russia alone. GCT is responsible for the site management, providing the full service clinical operations support, logistics and regulatory services.

On average, regulatory approval in Russia may take 3 – 3,5 months. We look forward to the first site initiation for this significant and exciting project.

New office in Poland

As our coverage grows and our local teams expand, Global Clinical Trials office in Poland has moved to a new, larger location on Wednesday, 28th of August 2019.

The new address in Poland is:

Mlądzka 10, 04-136

Warsaw

We look forward to new changes and congratulate our colleagues in Poland on the exciting news!

Phase II gastroenterology global study expansion to Ukraine and Russia

GCT has been awarded a new major project by Kangen Pharmaceuticals – a Phase II parallel-group dose-ranging study to evaluate the safety and efficacy of the drug compared to placebo in patients with chronic pancreatitis. Being the experts in the Eastern Europe for 17 years, our team will be responsible for handling the full range of regulatory activities and regional project management in Russia and Ukraine.

In order to enhance the enrollment and to keep up with the Sponsor’s timelines in the US-based study, GCT has conducted feasibility and offered a strategy to facilitate the recruitment of 164 patients.

 

 

Rare CNS Genetic Disorder Study Award

Global Clinical Trials is initiating a new Phase III study in pediatric population in Russia. This important project is the continuation of the existing collaboration between GCT and our long-term partner pharmaceutical company based in the U.S.

It is a double-blind, randomized, placebo-controlled study to be followed by a long-term open-label treatment. The trial will be conducted in children and young adults with a rare genetic mutation in the X-chromosome. GCT is responsible for managing all the centers in Russia, including the full scope of clinical operations, logistics services and regulatory support. The regulatory submission was performed as planned.

The investigational medicinal product has already been studied in more than 1,500 subjects, both adults and children. The studies have shown that it is safe and well-tolerated. Furthermore, the data from the previous Phase II trial, managed regionally by GCT, proves the efficacy of the IP. The majority of the patients qualified for the continued treatment demonstrated reduction in seizures, one of the major symptoms of the disease.

 

 

 

SIVs are completed for the neurodegenerative disease trial

 

This month GCT team has completed all scheduled Site Initiation Visits for the phase II, double-blind, placebo-controlled study in patients with mild-moderate Alzheimer’s Disease.

This USA based clinical trial aims to evaluate the safety, tolerability and preliminary efficacy of the investigational product.

GCT is responsible for the full scope of services: project management, site management, monitoring, IRB interactions and regulatory support in the U.S.

Pictured: a PET scanner
Image credit: Jens Maus, in public domain

Enrollment opens for an Ophthalmology trial in Russia

We are excited to announce the enrollment launch for the Phase III study in patients with ocular hypertension or primary open-angle glaucoma.

This ophthalmology study is multicentre, investigator-masked, and cross-over. Being a non-inferiority and a comparative trial, it aims to evaluate the efficacy and tolerability of an eye drop solution used to treat increased pressure inside the eye.

Global Clinical Trials is responsible for local project management, regulatory services, site management, and logistics services.

Pictured: a diagram showing the visual field in a patient with glaucoma, measured by a campimeter. Image credit: Pignol23, under CC BY-SA 3.0

Database Lock for Non-Hodgkin’s Lymphoma Study

We are delighted to announce the achievement of a huge milestone in the Non-Hodgkin’s Lymphoma Phase II trial. Database for this oncology study was locked last Thursday, 18 April 2019.

This is a randomized, parallel group multicenter international study. Global Clinical Trials has been responsible for the full support of the trial in Ukraine, including regulatory support, site selection, and monitoring at the Ukrainian sites.

Thank you to everyone participating in the study for your hard work and efforts. Now GCT is preparing for study close-out.

Image credit: Kiev, in public domain

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.

Picture credit: Image by Steve Buissinne from Pixabay, in public domain

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!

  (more…)

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

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