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).

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).

Aleksandr Stiblo attended VIII Life Sciences Invest. Partnering Russia forum

Last week Aleksandr Stiblo, GCT Deputy Director Business Development, participated at the VIII International forum “Life Sciences Invest. Partnering Russia” in St. Petersburg, Russia.

It is a great opportunity to enhance the business contacts of companies and investors within life sciences industry in Russia.  The Forum aims at supporting current federal initiatives to develop the pharmaceutical market as one of the key areas that provide a comfortable life and stability, creating the basis for a dynamic economic growth of the country.

Thanks to its biggest population in Europe and high qualification of investigators, Russia has a great potential for clinical trials. FDA and EMEA inspections confirm the high quality of clinical data. The government continues to reduce administrative barriers and simplify registration procedures in the Russian Federation.

GCT has 17 years of experience on the clinical trials market in Russia in different phases and indications. To discuss potential project, please write to bd@gctrials.com.

 

Happy Thanksgiving Day 2018!

GCT team wishes Happy Thanksgiving Day to all our US followers!

 

 

 

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

Victor Litvinskiy birthday

Today GCT Russian office celebrates the beginning of one more amazing year of Victor Litvinskiy, Junior Clinical Research Associate. Working alognside such an optimistic and helpful colleague is a great pleasure. Dear Victor, we wish you only the best in everything that you do!

GCT Signs A Contract With US Pharma Company To Conduct Global Phase 1-2 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.

 

 

GCT President, Dr. Jeffrey T. Apter, at CNS Summit 2018 in Florida, USA

GCT President, Dr. Jeffrey T. Apter attended CNS Summit 2018 in the The Boca Raton Resort & Club, Florida, USA. It is a great opportunity for pharma and biotech R&D leaders, the top tech companies, investigator sites, service companies, and the regulators from US FDA and EMA to recognize industry trends, lessons and experiences of the year. The Summit is known for its innovative content and format, building the community passionate about shaping the future, with a focus on collaboration, innovation, and technology.

Over the years GCT has gained a great experience of conducting clinical trial in CNS field in United States, Central-Eastern Europe and India. We are closely familiar with key opinion leaders in this therapeutic area, as well as experienced investigative sites and patient organizations and we will gladly apply this knowledge to assure the successful completion of your next planned clinical program.

“The real way from research and development to medicines” in Moscow, Russia

The International Conference “The real way from research and development to medicines” was held on November 1-2, 2018 in Moscow, Russia. GCT Regulatory Manager, Irina Golovacheva, participated in the conference and shared her knowledge and expertise in clinical research in pediatrics, new patient-based technologies in clinical trials, and modern trends in the scientific development of medicines, biomedical cellular products and medical products.

GCT is proud to maintain 100% successful regulatory track record in Russia. This is a shared achievement of GCT Regulatory team that gives a personalized attention to each of the submission packages and carefully evaluates the Sponsor’s dossier for the Russian Ministry of Health (Minzdrav) requirements.

 

Yuliya Pavlenko Birthday

The warmest birthday greetings go today to Yuliya Pavlenko, GCT Project Manager!

Dear Yuliya, your determination and enthusiasm is a great source of inspiration to everyone of us. Wishing you a wonderful day and prosperous life!

GCT President, Dr. Jeffrey T. Apter, at CTAD-2018 in Barcelona, Spain

Dr. Jeffrey T. Apter, GCT President, is now at 11th Clinical Trials on Alzheimer’s Disease which takes place on October 24-27 in Barcelona, Spain.

The aim of the conference is to overcome the hurdles and speed the development of effective treatments. These days clinical trial teams from worldwide centers report on their efforts to identify new biomarkers of Alzheimer’s disease as well as more sensitive clinical assessment tools to identify those at risk for AD, to predict progression, and assess the effectiveness of new treatments.

Eugene Selivra at EM-Phases 2018 in Prague

Today was the opening day of the EM-Phases Conference in beautiful Prague, Czechia.

This 2-Day event serves as a professional platform for all parties involved in improving and advancing clinical trials in Central, Eastern & Southern Europe, Turkey & MENA, Russia & EAEU. The representatives from regional Pharma, Biotech, CRO’s, clinical sites and investigators are discussing the specifics of multi-regional clinical trials, expedited and secure regulatory pathways, recruitment and retention challenges, site engagement and best practices for effective local and global project management.

Our CEO, Eugene Selivra, MD delivered his presentation “Do you need a local partner to speak the local language?” about benefits of working with locally based CRO when bringing a clinical trial to the unique regions across CEE.

GCT is proud to be one of the key Sponsors for this year event.

Eugene Selivra MD and Michaela Vancova, Clinical Operations Director, Slovak Research Center S.R.O

About

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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