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

Eating Disorders Awareness Week

Today, Monday the 25th is the beginning of the Eating Disorders Awareness Week.

Raising awareness about eating disorders is crucial. According to World Health Organization, eating disorders have the highest mortality rate of any mental illness. Statistically, only one in ten sufferers will seek and receive treatment. Today, there are numerous hotlines created for people suffering from eating disorders. However, embarrassed of their problem and afraid of being stigmatized, many are hesitant to ask for help.

Let’s fight the stereotypes about eating disorders and learn more about them today, so we and our children can have healthier, happier and longer lives tomorrow!

 

 

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.

66 Years Ago Today…

Today we are celebrating a huge milestone in scientific advances! 21th of February 1953 was marked by the discovery of the double helix, the twisted-ladder structure of deoxyribonucleic acid (DNA). James Watson and Francis Crick, the scientist were awarded the Nobel Prize in medicine for their discoveries.

 

Dr. Apter Attends ISCTM Scientific Meeting

GCT President, Dr. Apter will participate at the ISCTM 15th Annual Scientific Meeting this week. The event will take place in Washington, DC on February 19-21. During the conference, the attendees will discuss current challenges in CNS drug development, strategies for effective data management, as well as other subjects associated with clinical trials and methodology.

GCT looks forward to sharing our knowledge and experience in this challenging yet exciting area of study.

Happy Birthday to Elizaveta Medvedeva!

Today is the birthday of Elizaveta Medvedeva, GCT newest Business Development team member! We wish Elizaveta to enjoy the adventure of entering clinical trials field and to feel great support amongst colleagues at GCT.

Dear Elizaveta, have a wonderful, healthy, fun and exciting year! Happy Birthday!

 

International Epilepsy Day 2019

Neurologic disorders are the leading cause of death and disability in the world. The number of people suffering from them has increased dramatically over the past 25 years. According to the Neurological disorders: Public health challenges report from WHO, nearly 1 billion people worldwide suffer from various neurological disorders, and 50 million suffer from epilepsy.

International Epilepsy Day is celebrated every year on the second Monday of February. It is organized by International Beruea of Epilepsy and League Against Epilepsy, and it aims to promote awareness about the disorder.

Since 2001, GCT has been actively participating in CNS studies. We have gained a substantial experience in clinical trials for numerous neurological disorders. Among them are multiple Phase I-IV studies in Multiple Sclerosis, Alzheimer’s Disease, Schizophrenia and Acute Ischemic Stroke. For example, we recently have completed a Phase IIb and a Phase III trials for resistant partial-onset seizures (Epilepsy) for a US pharma. Both GCT President, Dr. Jeffrey Apter and CEO, Dr. Eugene Selivra are psychiatrists with 25+ years of experience in the CNS field.

Here at GCT we hope that new clinical studies will deliver more effective methods of coping with Epilepsy and other nervous system disorders.

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!

 

And the Winner is…

We just had a raffle at GCT booth for our friends at DIA Europe 2019. Making the most of the conference, Christoffer von Sehested the lucky winner received a really special prize!

Greetings from GCT Team at DIA Europe

It is the last day of the DIA Europe 2019! While enjoying the productive and friendly atmosphere of the conference, do not miss a chance to stop by our booth #B14 and learn how to improve recruitment and data quality by choosing the right partner CRO and the right region for your clinical trial.

GCT team is currently attending the 3-day conference that takes place in Vienna. Dr. Selivra, CEO, Aleksandr Stiblo, Deputy Director Business Development, and Yuliya Pavlenko, Project Manager are sharing their knowledge and connecting with prospective partners.

We look forward to meeting with you!

 

World Cancer Day

 

Most of us do not often think about Cancer in our daily life. This is why Health Awareness Days do make a difference. They can bring our attention to cancer among other medical conditions we may never have encountered or even heard about. Though, they are really significant.

World Cancer Day, first organized by the International Union against Cancer in 2005, takes place on February 4th. “2019 marks the launch of the 3-year ‘I Am and I Will’ campaign. ‘I Am and I Will’ is an empowering call-to-action urging for personal commitment and represents the power of individual action taken now to impact the future.”

We are proud to say that cancer is one of the GCT’s main foci, contributing 21 % to the total number of studies. Conducting clinical research since 2001, GCT has completed cancer studies in indications like prostate, ovarian, breast and small cell lungcancer. At the moment, we are conducting a number of cancer trials for Non-Hodgkin’s Lymphoma (Ph. II), Peripheral T-Cell Lymphoma (Ph. I / II) and Liver Cancer (Device Study).

We believe that studying Cancer is crucial. Awareness campaigns are a chance to understand, to relate to, and to help those in need. In our turn, we will continue researching cancer cures and investigating their potential risks and benefits.

Wishing Dr. Selivra a Very Happy Birthday!

Today, Eugene Selivra, GCT CEO is celebrating his birthday, while on the way to the DIA Conference in Vienna.

Dr. Selivra received his medical degree from Pavlov Medical School in St. Petersburg, Russia. He then soon became the Head of Department at the prestigious Bekhterev Psychiatric Institute and submitted over 10 publications in CNS clinical research. He now has 25+ years of experience conducting and managing multi-therapeutic trials in the USA, Europe and Russia.

All of us here at GCT are grateful for the opportunity to work with Eugene. We look up to our CEO, as he is the person most dedicated to and passionate about his job, and his hard work is truly inspirational.

We would like to wish Eugene to achieve all the new goals that he has set out for himself. May new opportunities always open up to him, and luck be on his side! We look forward to seeing GCT continue to prosper and develop under Eugene’s leadership!

Have a Happy Birthday!

Sincerely,

-GCT Team

GCT is exhibiting at DIA Europe 2019

GCT will exhibit at DIA Europe 2019!
February 5-7 come to meet us at booth B14, or schedule a meeting via DIA app.

Eugene Selivra, MD, CEO, Aleksandr Stiblo, Deputy Director Business Development, and Yulia Pavlenko, Project Manager, will be there to connect with GCT’s present and future partners.

We look forward to seeing you in Vienna!

 

GCT President at 17th Annual MCI Symposium

GCT President, Dr. Jeffrey T. Apter will attend the 17th Annual MCI (Mild Cognitive Impairment) Symposium. The event will take place in Miami, FL on January 19-20.

These are some topics that will be discussed during the event:

  • Vascular and AD pathology interaction in MCI and dementia
  • MRI and PET scans in the diagnosis
  • Evidence for the effectiveness of neuromodulation
  • Cognitive training and behavioral intervention in maintaining cognition and everyday function.

GCT has a vast expertise in the CNS area, effectively managing numerous trials in Alzheimer’s disease, Multiple Sclerosis, Epilepsy and other medical conditions. We are always looking for new opportunities to learn more and to share our experience.

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

Bengaluru, India: AAIC Satellite Symposium

On 18-19th of December, Dr. Umakanta Sahoo, Managing Director GCT-India, attended the Alzheimer’s Association International Conference (AAIC)  Satellite Symposium. Together with other professionals in the field, he explored emerging research of dementia in South Asia. The meeting was focused on the role of genetics in developing Alzheimer’s,  emerging therapeutics and developments in Alzheimer’s clinical research, and recent advances in biomarkers.

Indian CNS sites still lack infrastructure for amyloid imaging, while PET and CSF are very expensive. There are still not so many clinical trials in AD being undertaken in India, although there are experienced PIs who are eager to be involved in international clinical trials. Indian pharma industry continues to acquire modern infrastructure and imaging tools and also evaluates other methods, such as biomarkers, to boost AD treatment in India.The importance of all stakeholders to understand the newest tools and techniques for effective and meaningful research in reducing the dementia load in South Asia was emphasized during the conference.

Dr. Sahoo shared that it was a great opportunity to meet up with industry Sponsors, researchers and investigators.

Dr. Umakanta Sahoo Attends AAIC Satellite Symposium, December 18-19, in Bengaluru, India

Dr. Umakanta Sahoo, Managing Director GCT India, will be at the Alzheimer’s Association International Conference (AAIC) Satellite Symposium, December 18-19, in Bengaluru, India.

With his outstanding academic background complemented by 30+ publications in peer-reviewed journals, Dr. Umakanta Sohoo has over 15 years of experience in CRO industry, 5 years of Experience in Food & Nutrition, pharmaceutical and textiles industry. (more…)

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.

Veronika Goriachikh happy birthday

Today Veronika Goriachikh, Head of our Central Depot celebrates her Birthday. Veronika is a passionate and dedicated person, whatever she does, she does with true care and professionalism. Dear Veronika, we wish you a great year ahead! Let it be full of joy and success. Happy birthday!

Nataliya Katsnelson will participate in the expert panel at the Clinical Trial Financial Management summit

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).

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