Global Clinical Trials is adding yet another COVID-19 clinical trial to its Infectious Disease portfolio. As a part of a multi-national project, GCT will manage the double-blind Phase III study in adult patients with COVID-19 in Russia. After a thorough feasibility analysis, GCT clinical team together with the Sponsor selected the clinical sites with the most enrollment potential.
As the COVID-19 pandemic is still ongoing and the mortality is considerable, the global population is in need of new treatment options to mitigate the virus. The safety and efficacy of the investigated drug has previously been confirmed during the phase II trial. The phase III study aims to further support the product efficacy claims.
The project is currently in the active start-up phase, with regulatory submissions ongoing. All site selection visits have successfully been performed by the GCT clinical team. “Doing our part in helping fight the consequences of the virus is extremely important to us and is the mission of GCT. We are thrilled to be working on another project with our long-term partner,” – said Dr. Jeffrey Apter, GCT President.
Updated: August 30, 2021
The enrollment was completed for a phase IV, multicenter, randomized, non-inferiority trial by reaching the study-wide goal of including 360 patients. GCT is responsible for managing project in Russia where the patient enrolment began in August 2020.
From the start of the trial, Russian sites selected by GCT showed an encouraging recruitment rate resulting in the decision to open additional sites in the country. Initially, Russian sites were to recruit 156 out of 356 subjects in the study with the enrollment being competitive between 3 countries. While the recruitment in other countries dropped due to the global pandemic, GCT Russian team rescued the study by eventually enrolling 256 instead of 156 patients.
“We are proud of the recruitment speed that the sites in Russia were able to achieve, despite the pandemic. Strategic partnerships between sponsors and CROs assuring the most effective patient enrollment approach is implemented, and the important milestones are achieved on time or beforehand,” said Jeffrey T. Apter, GCT President.
Updated: July 29, 2021
GCT has just been awarded a new clinical study related to SARS-CoV-2.
It is a double-blind, randomized, placebo-controlled, phase II study in hospitalized patients infected with severe acute respiratory syndrome-coronavirus-2. The Sponsor is a Swiss Biotech.
For this study, 150 patients will be enrolled at the Russian sites.
Coronavirus infection COVID-19 affects different groups of people to different degrees. Some of the patients with moderate to severe cases require hospitalization.
“For over a year now we have been in a difficult situation due to the pandemic. We are grateful to be a part of many СOVID-19 trials aiming to improve it,” said Dr. Eugene Selivra, GCT CEO. GCT has built up a solid portfolio of COVID-19 trials. Contact us at firstname.lastname@example.org to find out more and discuss your project.
Updated: July 28, 2021
The first patient has been included in this clinical trial in Russia. The study is a Phase 2, Multi-Centre, Open-Label, Single-Arm Trial Investigating the Safety, Efficacy of IP aiming to help those suffering from IPF.
Idiopathic pulmonary fibrosis is a chronic, progressive lung disease. When it occurs, scar tissue (fibrosis) is accumulated in the lungs, making it very difficult for the lungs to transport oxygen efficiently into the bloodstream.
“It is great news for the project and a milestone for GCT. Due to the pandemic, it has become increasingly more complicated to conduct pulmonary studies as these sites are often prioritizing COVID-19 patients. Moreover, eligible patients pool narrowing as many protocols are being amended now to include only vaccinated patients. We are proud to say that our Russian team with collaboration with the site and Sponsor was able to deliver despite the changing requirements.” – Dr. Jeffrey Apter, GCT president.
Updated: July 13, 2021
Global Clinical Trials announces the first successful screening in the endometriosis study.
It is a Phase III double-blind, three-arm superiority study in 200+ subjects that is being conducted in Ukraine. The study aims to assess the safety and efficacy of the Investigational Product (IP) for treatment of endometriosis in women of reproductive age.
GCT has been running Women’s Health clinical trials since 2001, and it is one of GCT’s main–focus therapeutic areas. GCT is well–familiar with Key Opinion Leaders (KOLs) and clinical sites, and utilizes this expertise to ensure an effective enrollment of patients for its projects.
“GCT is proud to achieve this milestone in such a short time. Together, GCT, sites, and the Sponsor’s team engaged all their efforts to make it happen, “ said Dr. Eugene Selivra, GCT CEO.
Endometriosis is an incurable but manageable gynecological condition. It occurs when endometrial implants, comprised of tissue normally found within the uterus, are present in other areas of the body. It is a long-term condition that can have a significant impact on the life of the patient.
To plan a new endometriosis clinical trial with GCT, please contact us at email@example.com.
Updated: July 6, 2021
PRINCETON, N.J. JUNE 22, 2021
Global Clinical Trials, LLC (“GCT”) is a premier contract research organization providing clinical services in the U.S., Europe, and Asia. The company is delighted to announce the celebration of 20 years helping small and large pharma, biotech and medical device companies run their clinical studies. In the following months, GCT will be publishing media content, including the stories of GCT employees and empirical lessons that contributed most to the growth of the company and its service offerings.
Founded in 2001, GCT transitioned from a well-known local provider in Central-Eastern Europe, to a global CRO with operations in 11 countries through offices in Bulgaria, Georgia, Hungary, India, Kazakhstan, Lithuania, Poland, Romania, Russia, Ukraine, and the U.S. GCT fully supports projects in various therapeutic areas from phase I through IV, providing targeted, flexible and cost-effective solutions.
“It has been a fantastic journey since we started literally from the scratch. Our team has grown both professionally and in number, and now we are able to support clinical trials globally. The driving force for all of us has always been changing needs of the customers” – shared GCT President, Dr. Jeff Apter.
During its 20 years on the market, GCT has achieved a number of milestones:
- Increased the number of full-time employees from <5 to 100+
- Established 11 clinical offices worldwide
- Managed clinical trials in Bulgaria, Czech Republic, Estonia, Georgia, Germany, Hungary, India, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Russia, Slovakia, Ukraine, and the U.S.
- Opened internal Data Management, Biostatistics and Medical Writing departments
- Enhanced the project portfolio with 200+ clinical trials
- Earned repeat business from the same clients
Eugene Selivra, CEO of GCT said, “GCT’s main objective has always been and remains the patients’ safety and well-being. Our business grew gradually: both by answering new opportunities and demands for particular country or service, and by relaying on the expertise and drive of local professionals pushing to add their countries to the map of clinical trials. After all, behind all our success, stand the people who are talented, passionate, and devoted professionals. Our biggest achievement is the customers’ confidence and trust in GCT. What used to be an idea is now a reality.”
Founded in 2001 by Jeffery Apter, MD and Eugene Selivra, MD, GCT is a premium contract-research organization (“CRO”) supporting Phase I-IV clinical studies and post-marketing activities for international and local Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions. GCT guarantees a tailored approach for every project and provides its clients with both standalone services as a functional service provider (FSP) and excellent full-service support during study start-up, active project phase and study close-out. GCT stays fully-compliant with the latest GCP, EMA and FDA guidelines, and local regulations.
Updated: June 23, 2021
Global Clinical Trials has been recently awarded to run a new project in Women’s Health.
A Phase III double-blind, three-arm superiority study in 200+ subjects with endometriosis will be conducted by GCT in Ukraine. The goal of the study is to assess the efficacy and safety of the Investigational Product (IP) for the treatment of endometriosis in women of reproductive age.
On March 23rd, 2021, the State Expert Centre of MOH of Ukraine has issued approval to begin the enrollment.
Endometriosis is one of the most common diseases of the female reproductive system; when it occurs, the cells of the endometrium (the layer lining the uterus from the inside) grow outside it. Endometriosis can affect women of any age. It is a long-term condition that can have a significant impact on one’s life. Fourteenthly, nowadays there are a number of treatment options that may help.
“This project is a wonderful opportunity for GCT to use its expertise and to enhance its experience in Women’s Health trials. The team is looking forward to the next milestone,” said Dr. Eugene Selivra, GCT CEO.
Updated: April 6, 2021
GCT has been awarded the international multicenter phase III clinical trial of a tumor-starving (anti-angiogenic) therapy. The global enrollment target is 608 patients diagnosed with Non-Small Cell Lung Cancer. The first patient was randomized by GCT in the U.S. beginning of 2021.
Lung cancer is the leading cause of cancer death in the United States and worldwide. NSCLC is a group of lung cancers that behave similarly, such as squamous cell carcinoma and adenocarcinoma.
GCT has identified and qualified over 100 sites globally. Our regional teams have been initiating start-up activities: while working closely with sites on feasibility, SQVs, and agreements, submission dossiers were completed and submitted to several regulatory authorities’ review last month.
“We are honored to run this project, which we hope will get our client’s product to the very competitive market of biosimilars. We did feasibility in 30+ countries and believe that the selected regions will be able to deliver maximum results within the required timelines”, Eugene Selivra, MD, Chief Executive Officer.
The services are being provided by GCT include ex-US regulatory affairs, IRB and local ethics committee submissions, clinical monitoring, project management, vendor management, safety and pharmacovigilance support, medical monitoring, clinical supply logistics support.
Updated: March 29, 2021
Global Clinical Trials has been selected to conduct a Phase I study in COVID-19 patients. The Investigational Medicinal Product is a nasal antiseptic formulation designed to ease the symptoms and reduce SAR COVID-19 viral load. It will be available over the counter for anyone in need.
The project is now in active start up with GCT medical writing team developing the needed documentation. GCT is responsible for the full-service clinical support including project and site management, medical writing, data management and biostatistics.
Updated: March 11, 2021
2021 is a very special year for GCT. We have been serving pharmaceutical and biotechnology companies since 2001.
This fall, GCT turns 20!
We are thrilled by the success of our clients and partners, that we achieved together throughout these years.
We grew from the first office in Russia to running 11 operational offices across the globe offering full-service clinical trial solutions in Bulgaria, Czech Republic, Estonia, Georgia, Hungary, India, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Russia, Slovakia, Ukraine, and the USA.
We strongly believe that our employees are the reflection and the main reason behind our success. So, on this special occasion, we would like to celebrate by telling a little bit more about who we are.
Our first employee to participate is Roxana Darie, GCT General director and Director for Legal Affairs.
- When did you join GCT and how long have you been at the company? Which office are you located at?
I joined GCT in 2015. I am located in Bucharest, Romania.
- Was the job what you expected it would be?
Well, yes! I expected it to be extremely exciting and variate, and it did not disappoint at all. I love working on multiple fronts and being involved in different activities across the departments and work with a lot of people. Keeps one on his/her toes.
- What’s changed at the company since you’ve joined?
I like to think that the legal department has changed in the EU since I have arrived. I know for sure that the GDPR implementation was a success, as well as the centralization of the legal activities and negotiations. We are also preparing to transition to Voluntary Harmonization Procedure (VHP) to facilitate the application for our global trials, where multiple member states are participating.
- What is the most important part of the company culture for you?
Knowing the people behind the positions is extremely important. And I love that at GCT people are well connected.
- Can you describe an event that was particularly memorable during your career at GCT?
I guess it might have been at the last IM that was done face-to-face, where I met both old colleagues and also new faces and it was as if we knew each other for half our lives.
- What have you learned working at GCT?
- What is different compared to other places you have worked for?
I found a place where professionalism is amplified by humanity, and passion by know-how. Also, it feels like a family where everyone has their place.
- From your point of view, what does GCT’s contribution to people’s lives look like? What is the most relevant thing that we do?
Being able to offer treatments and hope to people by presenting them with the newest technologies and medicines is what is relevant in our line of work.
- What motivates you to come to work each day?
My team. Be it local, or international, I love to meet with them face-to-face and in video calls, it is always nice to see and hear them.
- What are some of your favorite activities outside of work?
I write fantasy novels, for children and not only. I love discovering foreign cultures, going to classical concerts, and would not say no to a hike any given day.
Updated: February 10, 2021
GCT started the new year with conducting an Investigators’ Meeting on behalf of the European Sponsor – NanoGun Technology (NGT). NGT is an innovative company certified by the French government in nanomaterial biotechnology. IMDENDRIM is an experimental in situ anticancer treatment of solid tumors nonresponsive to conventional therapy.
The IM for IMDENDRIM study, which will be performed in Romania in patients with inoperable liver cancers non-responding to standard therapy, was organized to train investigators and their clinical staff on trial related activities, discuss the protocol, study design, standard operating procedures, GCP, GDPR and other topics. The meeting was held online due to travel restrictions. Attendees from France, Germany, Belgium, Romania, and China participated in the meeting, including the Sponsor representatives, Investigator site team and the CRO team.
“IMDENDRIM is an intelligent nanomedicine device that is ideal in situ treatment for inoperable and non-responding to conventional therapy tumor,” – Pr. SADEG Nouredine, PhD, Chairman of NGT.
“GCT has a vast experience in conducting clinical trials in oncology, and this exciting project is an opportunity to enhance it. Our team will be closely working with the study site to meet the recruitment goal, which will allow the Sponsor to continue with the technology registration in the EU and other regions,” – said Dr. Eugene Selivra, GCT CEO.
Within the study, GCT is responsible for the regulatory support, project management, clinical monitoring, medical writing, data management, biostatistics and CSR. In addition to conducting the trial, GCT will be supporting NanoGun Technology (NGT) with gap analyses and registration in the USA, China and the EU.
Updated: January 25, 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
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
In 2020 we enhanced the global presence with:
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.
Updated: December 24, 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 firstname.lastname@example.org with any questions or for a free feasibility analysis for your planned clinical program.
Updated: December 9, 2020
The Sponsor is running an international phase III trial in Crohn’s disease. Study recruitment is challenged by initial low incidence of the disease, combined with a big number of competing trials, as well as COVID-19 impact. As an escalation strategy and to reengage sites that are behind on the enrollment, the Sponsor decided to perform booster visits, including on-site visits by GCT team in Russia.
Patient recruitment and retention strategy is a huge part of proactive contingency planning of any the trial. Booster visit is an important component of the planning that allows sites and Sponsors/CROs to get together and develop an action plan to reach the enrollment projections.
“We are struggling with patient recruitment in this trial, and under normal circumstances we as a Sponsor make individual visits to each of our sites to boost patient recruitment. Still, the horrid COVID-19 pandemic is keeping us from making individual visits by ourselves, thus forcing us to find alternatives – booster visits made by local CRO. It is the fact that local CROs are more likely to have pre-existing strong relationships with PIs or other personnel who can positively affect patient recruitment. Our aim is to make booster visits to those sites by GCT (with pre-existing relationships and rapport) and to have positive effect in patient recruitment that we are having a hard time with.”
GCT is a full-service clinical research organization operating in Russia since 2001. The company have established strong relationships with PIs and sites countrywide. GCT has scheduled face-to-face meetings with Investigator site teams in Kazan, Irkutsk, St. Petersburg, Moscow, Tomsk and Samara. Moreover, the first visit has already been conducted.
“Nowadays, it has become complicated for Sponsor to closely oversee the process of clinical trials due to travel restrictions. Having a reliable and experienced partner who is able to provide a high-level service and engage the study team is the key to solving this problem” – said Dr. Eugene Selivra, GCT CEO.
Updated: November 30, 2020