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 email@example.com 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
Princeton, NJ, USA, Nov 12, 2020
Global Clinical Trials is initiating a Phase I clinical study in Relapsed or Refractory Lymphoma for a US biotechnology company, OncoTartis, Inc.
“I am excited that clinical trials with our promising drug candidate OT-82 will now include several clinical sites in Russia. In preparation for this trial, our team was impressed by the knowledge, experience, and professionalism of people at GCT. I am confident that everything possible will be done to bring our trial to success despite the tough challenges posed by the Covid-19 pandemic” – Alexander Polinsky, Ph.D., Founder & CEO, OncoTartis.
GCT will be responsible for the local study management throughout all stages of the trial, including start-up activities, regulatory submission to Ministry of Health and Local Ethics Committees, project and site management, clinical monitoring, and the full cycle of the complex study logistics. GCT team will organize the IMP and CTMs import, customs clearance and local distribution to the sites, as well as biosamples export to the central laboratory. The IMP, ancillary supplies, equipment, and biosamples will be stored at GCT depot in Saint-Petersburg under required temperature regimes. In addition, GCT will manage the IMP preparation that must be performed individually before each administration. Our team is looking forward to achieving the first milestone – receiving the regulatory approval.
“We would like to thank OncoTartis for entrusting GCT such an important project. Given the limited number of treatment options available for this indication, we are excited to make our own humble contribution to the development of one,“ said Dr. Eugene Selivra, GCT CEO.
Proving clinical research services to pharmaceutical, biotech and device companies for over 19 years, GCT has gained extensive experience in various oncology studies, including multinational projects for European, US and Asian Sponsors.
Updated: November 12, 2020
Princeton, NJ, USA, Nov 12, 2020
Global Clinical Trials launches new gynecology study in Ukraine. The project is sponsored by young EU biopharma company focused on research in women’s health.
It is a multicenter, open-label, single-arm Phase III study in 160 patients suffering from endometriosis. The study is designed to assess the safety and efficacy of the Investigational Product and will be conducted at up to 13 sites in Ukraine.
GCT team is providing the local support for the study including regulatory affairs, study and site management, clinical monitoring and logistics of IMP and clinical supplies.
“GCT team appreciates the trust of our partners and the repeat business they bring to us. At this time Ukraine is prepared for new studies more than ever with joint efforts of the regulatory authorities, healthcare professionals, and experts in the field,” – said Dr. Eugene Selivra, GCT CEO.
Updated: November 12, 2020
Despite of COVID-19 challenging the routine of clinical trials worldwide, Global Clinical Trials has successfully randomized the first patient into a clinical trial evaluating the efficacy of IP in the sore throat pain relief.
This is a phase IV, multicenter, randomized, non-inferiority trial aiming to enroll over 300 patients globally.
The first patient was enrolled only 4 days after the site activation.
“We are honored to manage this clinical program in Russia and to be able to deliver FPI shortly after site initiation. At the same time, keeping patients, site and GCT staff safe is our ultimate focus. We are hoping the trial will be a success and will improve treatment options for patients in Eastern Europe,” said Eugene Selivra, MD, CEO of Global Clinical Trials.
Updated: October 8, 2020
GCT team is proud of taking part in the achievement of the major milestone for the Phase III clinical trial. The study is being successfully conducted, amidst the present difficult global environment, in pediatric patients suffering from a rare neurological disease. It is a randomized, double-blind, placebo-controlled trial followed by a long-term open label treatment. In January 2020, GCT successfully completed the enrollment of patients in Russia. We have now reached the next milestone – the Database Lock.
Despite all the challenges caused by the pandemic, the GCT team was able to follow each patient closely and ensure they complete all the required assessments, keeping trial participants safe during the treatment stage. This trial required a high level of GCT expertise and involvement, which the team successfully delivered.
“The sponsor of this trial, a US Pharmaceutical company, demonstrated an incredible level of trust in GCT, for which we are extremely grateful. We hope that our professional relationship will continue to grow and develop in the future,” – Dr. Eugene Selivra, GCT CEO.
Updated: September 7, 2020
Global Clinical Trials is managing its first local project in the country of Georgia. It is a recently awarded observational Phase IV clinical trial in Multiple Sclerosis.
GCT team is performing local management of the multinational study sponsored by an international Big Pharma. It includes trainings, regulatory documentation handling, adjustment and submission of amendments, site monitoring and close-out, and the eTMF maintenance.
Georgia is known for the fast regulatory approval of clinical trials, which only takes 30 working days. The submission package is similar to that in the EU countries.
While the clinical trials market in Georgia is still emerging, the key aspect is to find the CRO with local expertise. As a boutique CRO with the focus on CNS and Neurology clinical studies, we are proud to share our insight during this trial. The executive oversight is provided from both GCT President, Dr. Jeffrey Apter and CEO, Dr. Eugene Selivra who are trained psychiatrists with 50+ years of combined experience in clinical research.
For any inquiries about CNS and Neurology clinical trials, and clinical trials in Georgia, please get in touch with GCT BD team at firstname.lastname@example.org.
Updated: September 1, 2020