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.

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!

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.

 

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.

 

 

“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!

Victoria Kurbanova birthday

Today  our dear colleague Victoria Kurbanova, GCT CRA, celebrates her birthday!

Victoria, we all are very happy to have you in our team and appreciate your work greatly! May all your wishes come true and let the years ahead of you be interesting, exciting and joyful!

Thank you for working with GCT and Happy Birthday!

GCT at BIOTECHMED 2018 in Gelendzhik, Russia

The third annual BIOTECHMED conference has started at Grand Hotel Kempinski in Gelendzhik, Russia. One of the main missions of BIOTECHMED is facilitation of the export potential of Russian pharmaceutical, medical and cosmetic industries. The conference also addresses the issue of business – government interrelations.

Another hot topic discussed widely during the event is digitization in healthcare industry, particularly digitization and personalization in medical assistance.

The plenary session held yesterday was focused on Healthcare development in Russia and Worldwide – key directions, current tasks and strategies for biotechnology in the horizon of 2030-2035.

GCT Deputy Director Business Development, Aleksandr Stiblo, is representing GCT at the conference.

If you are interested in arranging an introductory meeting and discuss your plans for successful collaboration in the field of clinical trials, please contact us at bd@gctrials.com

Alina Mitrofanenko Birthday

Our wonderful colleague Alina Mitrofanenko, GCT Project Manager, celebrates her birthday today!

Dear Alina, we are so happy to work alongside such an enthusiastic and proactive person like you! Your ability to find time and resources to support every team member is incredible. We wish you best of luck, tons of success and a happy year ahead!

 

GCT team enhances QA capabilities

It is never enough when it comes to quality. GCT quality assurance system is meant to increase customer confidence and company’s credibility. Throughout the years we have passed over 65 internal and external audits with no major findings and are not going to slow down.

This month we are happy to welcome the accomplished pharma business professional as a new member of our dedicated Quality Assurance team in Russia.

GCT conducts independent vendor/facility audits in compliance with ICH guidelines and other applicable regulatory requirements. Our QA Department is in close contact with QA experts in the region and we are happy to engage professionals with a profound clinical research experience in our work. Our team of highly professional QA experts with 18+ years of experience in clinical research and a solid record of audits and inspections will ensure the integrity of your clinical trials.

To order an independent GCP audit for reasonable price please contact us by bd@gctrials.com

Natalia Krupina Birthday 2018

Yesterday our amazing colleague and financial manager  Natalia Krupina had her Birthday. Natalia, we hope your special day was as great as you are! We want to watch your smile bloom every day when you come to work and we thank you for always making time to help everyone in the office! Wishing you tons of success and prosperity in your life! Happy Birthday!

GCT at the 4th St. Petersburg International Oncology Forum “WHITE NIGHTS 2018″

Alina Mitrofanenko, Irina Ryzhkova and Aleksandr Stiblo at White Nights Oncology Forum

4157 participants visited the forum organized by the National Research Institution of Oncology last week to discuss issues of epidemiology, screening and prevention of cancer.

While pharmaceutical companies presented on the latest drugs and formulations, leading investigators were interested to learn more about latest trends in clinical research. Many of PIs that attended the forum have immense experience in clinical research and participated in international multicentre trials manages by GCT. Russian clinical sites are fully equipped and qualified to conduct clinical trials in various oncology indication.

Irina Ryzhkova, Deputy Director Legal Affairs at GCT-Russia spoke on “Protecting Investigators’ Rights” topic, which triggered heated debates among participants at the round-table discussions that followed. Irina identified parties that investigators interact during their work (Sponsors, CROs, sites, patients and regulatory authorities), typical reasons for raising a claim, and the ways how the rights of investigators can be protected.

Certificate of attendance White Nights Oncology Forum

Interested to learn more? Please contact us by bd@gctrials.com

Fourth St. Petersburg International Oncology Forum “WHITE NIGHTS 2018″

Irina Ryzhkova, GCT corporate lawyer, will give a speech on the topic “Protecting Investigators’ Rights” at the Fourth St. Petersburg International Oncology Forum “WHITE NIGHTS 2018.

The Forum will take place in Park Inn Pribaltiyskaya Hotel, St. Petersburg, Russia on July 5—8.

This is the one of the largest events in the field of oncology that unites a wide range of specialists from Russia, CIS and far-abroad countries; the main objective of the Forum is to consolidate the forces of the medical community to share the latest professional information in order to improve health care quality and reduce cancer incidence and mortality rates.

Polina Bushkovskaya Birthday 2018

Today GCT wishes Happy Birthday to beautiful member of our GCT Russia team, Polina Bushkovskaya!

Dear Polina, thank you for the support you provide to all of us! Today is a perfect day to let you know how much we all appreciate you and the work you do. May you succeed in achieving all your dreams. Have a wonderful Birthday!

White Nights XXIV International Ophthalmology Congress 2018 in St. Petersburg, Russia

The “White Nights” International Ophthalmology Congress takes place this week, May 28 — June 1, 2018 in St. Petersburg, Russia. This is a Russia’s leading event for local, regional, and international Ophthalmology professionals.

(more…)

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…)

Victory Day – May 9th

GCT Russian office celebrated Victory Day on May 9th. Together with our family and friends we have marched in ‘Immortal Regiment’ procession in St. Petersburg carrying flowers and portraits of relatives who fought in World War II. This march was just one of many held in at least 50 countries. The prosession followed by an impressive display of fireworks to commemorate the heroes of the war.

RakFond founding meeting

GCT at RakFond meeting

Aleksandr Stiblo, GCT Business Development Manager, attended the founding meeting organized by The Foundation for Cancer Research Support (RakFond), non-profit organization located in Moscow, Russia.
On April 26th founders, board members and partners of RakFond shared the latest news related to the development of new methods and tools for the prevention, diagnosis and treatment of cancer in Russia and worldwide.

Subscribe to our mailing list

Marketing Permissions

Please select all the ways you would like to hear from Global Clinical Trials (GCT):

You can unsubscribe at any time by clicking the link in the footer of our emails. Please see our Privacy Policy. We use Mailchimp as our marketing platform. By clicking below to subscribe, you acknowledge that your information will be transferred to Mailchimp for processing. Learn more about Mailchimp's privacy practices here.

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.

Go social with us

Follow us on social networks:

Privacy policy, Terms of service, Site map, Employees login

 

GCT

© 2001—2019 Global Clinical Trials, LLC

All rights reserved.