Important facts about Glaucoma:
Glaucoma is one of the leading causes of vision loss and blindness worldwide.
Glaucoma is caused by damage of the optic nerve.
Vision loss caused by glaucoma is permanent.
Glaucoma has no symptoms at its early stages.
Early treatment can stop the further damage caused by glaucoma.
Regular comprehensive sight examinations are the best way to protect yourself against developing glaucoma.
Global Clinical Trials focuses on conducting clinical research in Ophthalmology: https://gctrials.com/white-papers/nosology/ophthalmology/. For more information, contact us at bd@gctrials.com.
Updated: January 22, 2021
GCT Business Development Director, Aleksandr Stiblo is participating in China Focus Global Life Science Summit 2021.
The event brings together the pharma and biotech industry professionals and investors to facilitate valuable business connections. It is a great platform to learn more about opportunities and market in China.
The virtual event takes place from 10th to 14th of January. Contact us at bd@gctrials.com to schedule a call.
Updated: January 13, 2021
GCT has been selected to run a new project in patients diagnosed with PMM by its long-term Client. This Phase 2, multicenter, double-blind, placebo-controlled study will be managed by GCT team in Czech Republic and Hungary.
Primary Mitochondrial Myopathies are a group of genetic disorders affecting the skeletal muscle. The main symptoms of PMM are muscle fatigue, weakness, and exercise intolerance. The severity of these symptoms varies greatly from one person to another, and always affects the quality of life. It is caused by a mutation in genes of the mitochondria, and is one of the most common metabolic diseases. The new treatment aims to prove its safety and efficacy against the main symptoms of PMM.
GCT is responsible for a wide scope of services ranging from feasibility analysis and regulatory support to monitoring, site contracting and management. The trial is currently in startup in both countries with the sites already selected.
Updated: January 11, 2021
Global Clinical Trials first established its operations and a physical office in Ukraine in 2006. Ever since then, the country has been a highly fruitful addition to the company map. It has facilitated and accelerated enrollment of patients significantly for both local and global clinical trials.
Projects in various indications, including oncology, ophthalmology, CNS and others were successfully carried out during the years of operation in the country. Despite the global pandemic, Ukraine remained the country with much activity in clinical research in year 2020. We launched 2 new gynecology studies in Endometriosis and a Phase II study in idiopathic pulmonary fibrosis (IPF), a rare pulmonary indication. GCT team was also awarded a trial in COVID-19 infected patients to contribute to the global search for treatment options.
Among other projects, we are presently in the active start-up phase and opening 25 sites for a large global study in non-small lung cancer patients.
It is our pleasure to announce that we are moving to a new location to create an appropriate environment for our growing operations and headcount in the country.
Please update your records with our new address:
UCT Global, LLC
36а Verkhovynna vul.,
03115, Kyiv, Ukraine
Updated: January 7, 2021
Last Saturday, January 2nd, GCT Director and Project Manager in Hungary, Csilla Léka, MSc celebrated her birthday. We value Csilla’s professionalism and daily support, and would like to use this opportunity to express our gratitude for all her work at GCT.
Wishing Csilla a memorable year ahead from all of us!
Updated: January 5, 2021
On this beautiful day, GCT global team wishes a Happy Birthday to Prathyusha Thummala, our US-based Clinical Research Assistant.
Wishing you a day full of joy and happiness and a year that brings you much success!
Updated: December 29, 2020
We have endured unprecedented changes in the way we live, interact with each other, and work. This year more than ever, we are committed to remaining a reliable partner by advancing GCT processes both through traditional approaches and with the introduction of more virtual and remote solutions. As the winter holidays are celebrated all over the world and the New Year is just around the corner, our global team wants to take a moment to say thank you for your support and partnership. It motivates us to carry out our mission. Since the beginning, it has always been our priority making lives healthier. We wish you a warm and happy 2021. We look forward to continuing our collaboration in the upcoming year. Wishing you Happy Holidays!
From all of us at Global Clinical Trials
2020 CORPORATE
In 2020 we enhanced the global presence with:
2020 PROJECTS
In 2020 Global Clinical Trials was awarded new projects in the USA, the EU, India, Asia, Russia, and Ukraine. Our Clients entrusted GCT studies in various therapeutic areas: CNS, Oncology, Ophthalmology, Gastroenterology, Infectious Diseases, Rare Diseases, Pulmonary, Women’s Health.
The first local project in the country of Georgia was initiated by GCT in 2020. The observational Phase IV clinical trial in Multiple Sclerosis is a multinational study that was awarded by the US international Big Pharma.
Within the GCT Client base, there are big and medium-size Pharma, Biotech, and Device companies from the USA, Europe, Asia, the Middle East, and Russia.
In spite of the pandemic, GCT was able to achieve the enrollment goals for all studies this year. Remote monitoring and Investigator’s Meetings were in demand this year and played an important role in assuring the safety of patients, GCT employees, and site staff, as well as data integrity.
We provided the diverse scope of clinical trials services, including project management, site selection and management, full regulatory support in different regions, clinical monitoring, EU Legal representation and GDPR support, Medical Monitoring and Pharmacovigilance, logistics of the IMP, and clinical supplies, vendor management and other. In addition, GCT has implemented a number of patient recruitment tools, as well as provided the solution of local booster visits for Sponsors and CROs that do not have local resources and were restricted with travel.
With the emergence of new projects, we were also delivering on our ongoing projects. It is a pleasure to share with you some milestones that have been achieved during 2020:
- First Patient In Acute Infection Clinical Trial In Russia
- Database Lock for the Rare Disease Pediatric Study
- Regulatory Approvals for Chronic Pancreatitis Study in Russia and Ukraine
- First Patient In Chronic Pancreatitis Study
- 4 Sponsor Audits
- Enrollment Start for Phase II Ophthalmology Trial in Europe
- Enrollment Completion for POAG study
- End of Enrollment for Pediatric Phase III Trial
- Regulatory Approval for COVID-19 study in Russia
- Regulatory Approval for Rare Pulmonary Study in Russia and Ukraine
- Schizophrenia Scientific Project in Russia initiation
2020 CONFERENCES & EVENTS
Despite all the complexity of 2020, we utilized the opportunities that this year gave us.
GCT managed to attend several face-to-face events before they all got switched to virtual platforms, including SCOPE Summit in Orlando, the 16th Annual Scientific Meeting organized by ISCTM, Global Alzheimer’s Platform Foundation event, the 13th Clinical Trials on Alzheimer’s Disease Congress (CTAD).
Our global team shifted to virtual platforms and attended many events and conferences dedicated to innovation in the pharmaceutical industry, CNS area advances, updates in drug development, etc.
In May 2020 GCT participated in the COVID-19 Virtual Partnering Event.
Oleg Kurilov, General Director of GCT in Kazakhstan, attended the Virtual Pharmaceutical Marathon.
Represented by Nataliya Katsnelson, Senior Director of Business Development, and Elizaveta Medvedeva, BD Associate, GCT exhibited at the DIA 2020 global annual meeting.
Aleksandr Stiblo, GCT Director of Business Development participated in meetings, panel discussions, round tables, and keynote presentations at the World Vaccine Congress Europe 2020 and Eurasia Pharmaceutical Forum dedicated to the Clinical Research in the region.
Most recently, Dr. Dmytro Mozhynskyy, General Director of GCT in Ukraine participated in the sixth international scientific conference “Clinical Trials of Drugs in Ukraine”, which was a partially virtual and partially face-to-face meeting in Kyiv, Ukraine
Stay tuned and see what 2021 updates we will share. Global Clinical Trials invites you to follow us on social media:
We look forward to more exciting projects
and fruitful partnerships in 2021.
Happy Holidays!
Updated: December 24, 2020
Belated happy birthday to Anton Romanov, GCT IT Manager. Anton is one of the few employees that are working at GCT from the very day company was established.
Anton, we are all grateful for the work you do on the background, overseeing IT for a global company. We know we can count on your excellent support day and night. We wish you prosperity, health and happiness!
Updated: December 21, 2020
On December 20th our newest Business Development team member celebrated her birthday. Dearest Maria, we all wish you a very Happy Birthday and a great year ahead!
Your enthusiasm and bright smile sets the mood in the office. We wish you the great success in work and personal life! Happy Birthday!
Updated: December 21, 2020
December is full of celebrations. Today we are wishing a Happy Birthday to Anita Bereczki, GCT Clinical Research Assistant in Hungary.
Your dedication to work inspires us every day. Thank you for being an irreplaceable part of the GCT global team. Happy Birthday!
Updated: December 17, 2020
Today GCT office in Russia is celebrating the birthday of our wonderful colleague, Anastasia Kaylova, GCT Office Manager.
Anastasia’s appearance in the office brightens up the workspace and makes it more comfortable every day. Thank you for being so helpful, Anastasia!
We wish you lots of happiness and many great memories ahead. Happy Birthday!
Updated: December 16, 2020
Yesterday Aleksandr Stiblo, GCT Business Development Director, started his participation in the China Focus Virtual Conference.
The event offers a great opportunity for professionals in the pharmaceutical industry, investors and innovators to meet potential partners from China and all over the world.
Please contact us at bd@gctrils.com with any questions or to schedule a meeting.
Updated: December 15, 2020
Today Maria Kokalova, GCT Business Development Associate in Russia, took part in the annual conference “Drug development and registration. Drug research during the COVID-19 pandemic”.
This event was held virtually and organized in cooperation with a scientific Russian journal “Drug development and registration” («Разработка и регистрация лекарственных средств»). The invited speakers highlighted some of the hottest topics in drug development such as “the research of biotechnological drugs” and “drug research in the context of the COVID-19 pandemic”.
It was a pleasure discussing the recent updates in the Russian pharmaceutical industry with fellow professionals.
Updated: December 11, 2020
GCT has been awarded a new multinational scientific project in patients diagnosed with Schizophrenia and other related psychiatric disorders.
There is little knowledge of gene-environment, gene-gene and other relevant causal interactions in the development of schizophrenia. The project aims to identify some of the risk factors predisposing patients, as it is vital for effective prevention and finding a potential cure of schizophrenia.
GCT will manage the whole scope of services for the project including the local biosamples logistics and regulatory support.
Updated: December 10, 2020
With more than 19 years of experience in conducting CNS trials, we are now seeing that studies in Eastern Europe are becoming more and more popular among sponsors worldwide.
Aside from cost-effectiveness and high incidence rates in CNS disorders, there is another important factor that makes clinical research in EE even more attractive. It is lower placebo response rates in patients.
Placebo response in CNS trials is substantial and increasing. High placebo response rates have become an important problem, especially in the trials taking place in the USA.
Last year, Intra-Cellular ran two identical studies in Bipolar Depression. The 401 trial was entirely conducted in the U.S. and did not meet the primary endpoints due to the high rate of placebo response. Intra-Cellular announced the positive top-line results with significantly lower placebo response rate for the 404 trial, which was conducted globally with most patients recruited in Eastern Europe.
Another global study in Schizophrenia was conducted by ACADIA Pharmaceuticals and showed consistent improvement in psychotic syndromes. Even though it failed to meet the primary endpoints, the analysis by region showed consistent positive results for the European population including patients from Bulgaria, Czechia, Hungary, Poland, Serbia, Ukraine and Russian Federation.
Patients’ high placebo response calls the value of many CNS medications into question. Ever since the issue emerged, the sponsors have been in search for methods to mitigate it.
Many of them have found it useful to diversify the trial by adding regions with potentially lower placebo response rates among patients. One of such regions is Eastern Europe, where GCT established full-service operations and have been running clinical trials since 2001.
GCT is your partner in clinical trials in Eastern Europe because it combines global reach with local expertise. Both GCT CEO, Dr. Eugene Selivra and GCT President, Dr. Jeffrey Apter are trained psychiatrists with 50+ years of combined experience in clinical research. Dr. Jeffrey Apter is a Key Opinion Leader (KOL) in Depression and Alzheimer’s Disease. Moreover, GCT has close ties with the international CNS community and is an expert in the latest innovations in CNS clinical research.
“AbbVie partnered with Global Clinical Trials in the conduct of Alzheimer’s disease clinical trials in sites across Eastern Europe. This partnership proved to be invaluable. Trial results have been published; demonstrating statistical separation of positive control (donepezil) from placebo, low placebo response, and low statistical variability on endpoints, including the primary endpoint,” – George Haig, Pharm.D., former Group Project Leader at AbbVie.
Are you planning a clinical trial in the CNS therapeutic area? Contact our BD team at bd@gctrials.com with any questions or for a free feasibility analysis for your planned clinical program.
Updated: December 9, 2020
Today is a very special day as it is the birthday of our two valuable colleagues, Daria Podgorska, MD, MBA, and Roxana Darie, LL.M. Daria and Roxana are GCT General Directors in Poland and Romania, respectively.
All of us here at GCT wish Daria and Roxana a day full of laughter and happiness, and a year that brings you much success. We feel very proud to have such versatile and hardworking persons on our team. Happy birthday!
Updated: December 9, 2020
The National Influenza Vaccination Week (NIVW) is observed from December 6th to 12th to remind us of the importance of influenza vaccination. Those who suffer from asthma, diabetes and heart disease are most vulnerable to developing serious flu complications.
The global COVID-19 pandemic makes NIVW more vital than ever as it can place a huge strain on the health system and lead to a much higher number of illnesses, hospitalizations and deaths than during a normal flu season.
Updated: December 7, 2020
Today, December 3rd, our global team wishes a Happy Birthday to Marta Dominik, M.Sc., GCT Clinical Research Associate in Poland.
We wish Marta much happiness on her special day, and hope she has a wonderful time!
Updated: December 3, 2020
