GCT has just opened a new, GMP, GDP, FDA, EMA, and Russian national regulations -compliant pharmaceutical warehouse in St. Petersburg, Russia.
It has passed a thorough state inspection and received a license to store registered drugs and medicinal products.
The facility is a newly refurbished block of 243 m. sq. located in a 24/7 guarded logistical complex. It has a digital climate control system, digital online temperature and humidity monitoring and logging system, walk-in and stand-alone refrigerators, backup power supply, and a modern office with a digital inventory, labeling, and accountability tools. The staff is experienced and highly competent. The warehouse is ready to store and process shipments in multiple temperature regimes, including ambient, refrigerated and frozen. At GCT clinical warehouse, it is also possible to re-label IPs for clinical studies.
Updated: December 10, 2021
Global Clinical Trials is managing a Phase I clinical study in Breast Cancer. The project has recently been approved by the Russian Ministry of Health. This is the first drug created based on the modified oncogenic virus. Pre-clinical studies have shown that the Investigational Product is successful at eliminating cancer cells. The scientists have reason to believe it can also identify and target metastases. The drug has been developed by the Institute of Chemical Biology and Fundamental Medicine SB RAS, State Research Center of Virology and Biotechnology VECTOR in partnership with Oncostar, LLC.
During the clinical trial, it is planned to evaluate the safety, tolerability, and pharmacokinetics of the drug in patients with recurrent and/or refractory metastatic breast cancer.
GCT is providing full-service management of the project, including regulatory support, clinical site monitoring and management and the drug logistics.
“It is great excitement for us as a team to work on the break-through therapy aimed at fighting the most common type of cancer,” – said Dr. Eugene Selivra, GCT CEO.
Updated: December 9, 2021
GCT has been awarded a multicenter flu vaccine clinical trial in Russia. It will be carried out with participation of approximately 500 pregnant women at screening, and with a follow-up extension to babies. GCT possesses previous experience in conducting multinational studies in pregnant women with participation of 1000+ subject.
The sponsor, one of the largest research institutes in the country set strict requirements for CRO qualification process and challenging study parameters. Hence, GCT is proud to be the only local CRO eligible for the study conduct after the public tender procedure.
“GCT possesses solid resources and proven capabilities in Russia. We are confident to support this important study in cooperation with the client at the highest international standard of quality,” – said Dr. Eugene Selivra, GCT CEO.
The regulatory approval has already been obtained, and the study will be managed by GCT full-service onward. GCT logistics department will also support the supply and import of the comparator vaccine from oversees, utilizing the warehouse facilities owned in Russia. In order to minimize the number of onsite subject visits during COVID-19, the team considers using ePRO solutions for data collection at follow up visits.
Updated: November 10, 2021
Last week, GCT has been selected to conduct a bioequivalence clinical trial in a calcium channel blocker, Manidipine. The randomized, two treatment, two sequence, two way cross over, bioequivalence study of Manidipine Dihydrochloride tablets will be performed in Ukraine with participation of 30 healthy volunteers.
GCT will manage the full-service study support including medical writing, clinical and medical monitoring, regulatory, project management, site and vendor management, data management and biostatistics.
“We are thrilled to enhance our cardiovascular trials portfolio in Ukraine and to build strong partnership with our new client,” – said Dr. Jeffrey Apter, GCT President.
GCT has deep experience in the management and execution of BE / BA / PK clinical trials, in Ukraine and globally.
Updated: November 9, 2021
GCT has recently passed a sponsor audit in St. Petersburg, Russia. The sponsor company is one of the leading vaccine developers with a rapid clinical pipeline. The remote audit was conducted in order to confirm GCT’s adherence to GCP, the Declaration of Helsinki, the Rules of proper clinical practice of the Eurasian Economic Union, the local Russian regulations, and the sponsor’s policies. No major findings were identified. Following the audit, GCT was approved as a vendor of category “A” and authorized to participate in the sponsor’s commercial tenders.
Updated: September 28, 2021
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 bd@gctrials.com 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 bd@gctrials.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.”
About GCT
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
GCT has been awarded a new regulatory project — an ophthalmological study for a Korean biotechnology company.
A novel wet age-related macular degeneration (Wet-AMD) treatment is to be investigated. The sponsor has requested GCT to provide the regulatory support services for the IND application prior to the clinical trials.
GCT’s regulatory group will perform the necessary activities to file the IND and proceed with required clinical trials in US and globally.
Wet age-related macular degeneration develops when abnormal blood vessels grow into the macula. The main risk factor for this disease is early vision loss. It’s important to have routine eye exams to identify early signs of macular degeneration.
Nevertheless, the progress does not stand still, and some forward-looking companies are developing treatments for patients with Wet-AMD.
“We appreciate the interest and trust of our clients, especially when it comes to ophthalmological studies, which GCT is very experienced in conducting,” said Eugene Selivra, MD, Chief Executive Officer.
Having conducted ophthalmology trials since early 2000s, both for big pharma and domestic biotech, GCT is well familiar with the key opinion leaders and fastest recruiting clinical sites in this therapeutic area. GCT will apply its expertise to ensure the successful completion of the client’s planned clinical program.
Updated: June 8, 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
Global Clinical Trials has been awarded a Phase I study in COVID-19 patients by a U.S. sponsor. Proud to have 80% of the projects as repeat business, GCT is currently collaborating with the sponsor on another clinical trial in the U.S.
The Investigational Medicinal Product (IMP) is designed to ease the symptoms and reduce SAR COVID-19 viral load. The study will be performed in 30 patients at 2 sites in the U.S.
GCT is proving full-service support for the trial, including project and site management, medical writing, data management and biostatistics. The team is looking forward to the prompt start of the activities.
Updated: March 30, 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
Recently GCT was awarded a new regulatory project by a Greek Pharmaceutical company. It aims to develop a novel fixed-dose combination of the currently approved active substances doses into an immediate release film-coated tablet. The intended indication is “common cold with fever and nasal congestion”.
It was important to the Sponsor to receive advice from the Russian regulatory authority – Ministry of Health – on the best approach to clinical development. GCT expertise was requested to obtain the regulatory feedback on the clinical studies strategy, and marketing authorization path of the medicinal products in the Russian Federation.
Contact bd@gctrials.com, if you need help with clinical trials and marketing authorization for drugs and medical devices in Russia.
Updated: February 25, 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?
Dedication.
- 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
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
