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 email@example.com.
Updated: September 1, 2020
GCT has been awarded a new Phase I clinical trial in patients with breast cancer. It aims to prove the safety, tolerance and pharmacokinetics of the Investigated Medical Product (IMP) using the dose escalation method. The study will be conducted in Russia with enrolling 60 patients who suffer from palindromic or refractory metastatic breast cancer. The project is sponsored by a Russian biotechnology start-up company specializing in oncology research.
The clinical trial is now in the active start-up process, and the regulatory submission is expected in early September. Global Clinical Trials is currently in the process of performing medical and regulatory review of documents prior to the RA submission. GCT monitors will soon be performing Pre-Study site visits (PSVs).
Updated: August 3, 2020
GCT is proud to announce successful enrollment of the first patient in Russia in the Chronic Pancreatitis clinical trial. The multinational Phase II randomized double-blind Gastroenterology trial is aiming to enroll over 160 patients in total. GCT is managing the study in Russia and Ukraine and covering the full-service clinical support.
The 1st randomized patient was recently screened and approved for the study. In general, the sites in Russia have preliminarily shown a higher enrollment potential in comparison to sites in other countries. There are several dozen potential subjects who currently are in the pre-screening stage. These patients will be randomized for the study in the upcoming few weeks.
The pre-study and start-up activities for this study have been accomplished on time despite the restrictions and obstacles due to the COVID-19 pandemic. GCT team is looking forward to reaching the further milestones.
Updated: July 15, 2020
GCT has been awarded a new clinical trial in Ukraine and Russia. A Phase II multinational study in subjects with Idiopathic Pulmonary Fibrosis (IPF) is designed to investigate the safety, efficacy, and pharmacokinetics of the investigational product. IPF is a disease that is characterized by scarring of the lungs. As condition develops, it becomes harder and harder to breathe. There’s no cure for this disease, however medications can help manage the symptoms.
We are providing full-service clinical support in both countries, including feasibility analysis and site identification, regulatory support, monitoring, site management and financial management. The trial is currently in the start-up stage in Ukraine and Russia. Regulatory submission preparations and pre-study visits to the selected sites are in progress.
“Idiopathic Pulmonary Fibrosis is a serious and devastating disease, often with poor prognosis. We look forward to conducting this important trial aimed at improvement of patients’ quality of life. It enhances our extensive experience in rare diseases and, ultimately, will provide patients with more treatment options,” – Dr. Jeffrey Apter, GCT President.
Updated: July 7, 2020
Global Clinical Trials, LLC is awarded to run the rare disease project globally. The trial is already ongoing and managed by GCT in India. In addition to that, the sites will now open in Western and Mediterranean Europe, Western Asia, and Great Britain. GCT is providing regulatory, clinical trial management, EU Legal representation and GDPR support for this study.
The indication under research is an extremely rare genetic disease inherited as an autosomal recessive trait. It is characterized by variety of gastrointestinal and neurological symptoms that will result in complications, which heavily affect the lives of patients and their families.
“To manage such an important and geographically diverse project is a significant milestone for GCT. We are thrilled to be supporting the Sponsor across the globe using our on-the ground personnel,” – Dr. Eugene Selivra, GCT CEO.
Updated: June 25, 2020
Global Clinical Trials has been awarded a randomized, double-blind, placebo-controlled phase II clinical study in patients with COVID-19, SARS CoV-2 infection. GCT will manage project in Ukraine and Russia targeting to enroll about 50 hospitalized subjects in 1,5 months. The objective of the trial it to evaluate the drug safety and its effect on inflammation.
“On behalf of the Global Clinical Trials team, we are grateful and enthusiastic to contribute to the development of treatments against the Coronavirus Disease. I look forward to seeing what this project can bring to the global blueprint for patients affected by the virus,” – Dr. Eugene Selivra, GCT CEO.
The study has been contracted out to GCT this month, and our team is progressing quickly with start-up activities to ensure accelerated submission for this highly prioritized trial.
Updated: June 24, 2020
The “White Nights” International Ophthalmology Congress, taking place annually in St. Petersburg, Russia in late May, is one of the leading Ophthalmology events in the region. Every year the Congress attracts over 2 000 participants from all over Russia, Europe, the Middle East, and the Americas. For over a decade GCT has been the Exclusive Information Partner of the Congress, running the Congress website, providing organization and participant registration services.
This year, due to the global pandemic, the congress has been held as a hybrid event, with the speakers joining from the traditional congress venue rooms or remotely, and the registered participants accessing the video streams being broadcasted from the venue. Communication with the speakers was facilitated through an interactive chat in the member’s area on the congress website.
The virtual Congress has seen substantial growth in the participant numbers reaching over 5,400. GCT is proud to support the Congress in these challenging circumstances. We share our organizational expertise and technical capabilities to aid the delivery of the most recent and promising developments and updates in treatment to the medical professionals and the ophthalmic community.
Pictured: Plenary session of the Congress, 2019
Updated: June 2, 2020
Global Clinical Trials, LLC is initiating a new project in India. It is a Natural History Study of a rare congenital disease to be conducted at several clinical sites across the country.
GCT will provide clinical trial solutions for the study including the project management activities, site management activities, full regulatory support and clinical monitoring. The study is expected to initially last over 2 years. The project will be managed by Umakanta Sahoo, PhD, MBA who has an extensive background and over 20 years of experience in clinical research.
GCT has conducted numerous clinical studies in Rare Diseases and is familiar with Key Opinion Leaders (KOLs) in many regions, including India, Eastern and Central Europe and the USA. The company’s expertise is reaffirmed by an extremely high percentage of repeat business due to successful and timely completion of our projects.
Updated: May 21, 2020
This year GCT successfully passed 2 Sponsor audits. They were performed by independent auditors employed by the sponsor companies. From GCT side both audits were led by GCT QA expert and director – Vladimir Seredyuk, MD. Audits included review of project-specific topics, the company’s general procedures, capabilities, and the organizational structure. Neither audit yielded any critical or major findings.
The first audit was performed at the end of January in connection with the observational pediatric study that GCT is running in Europe since 2015. Lasting three days, it covered a broad spectrum of activities including: Staff Qualification and Training procedures, Quality Assurance, Project Management, Regulatory Affairs, Site Monitoring, Data Security/Backup practice, IT department policies, and GCT documentation practices.
The second audit occurred this past March in preparation of initiation of a phase IV trial in infectious disease, which is to be conducted by GCT at several sites in Russia. A review of study-related IT inventory, management procedures for handling Medicinal Product and Lab Samples was performed. The auditor also focused on the GCT’s Standard Operational Procedures (SOPs) and study specific documentation review.
The lack of audit findings confirmed our company as a strong global CRO-partner with on the ground expertise in different locations.
Updated: May 5, 2020
GCT has successfully obtained Regulatory Approval in Russia for a multinational Phase II randomized double-blind Gastroenterology study. The official approval from the Russian Ministry of Health (MoH) was received on March 20, 2020.
The goal of the study is to evaluate the safety and efficacy of the Investigational Drug compared to placebo in patients with Chronic Pancreatitis. The disease is characterized by inflammation of the pancreas, which worsens gradually and can cause permanent damage. GCT is managing the trial in Russia and Ukraine which is planning on enrolling over 160 patients.
The GCT team is fully operational and continues to support our clients without interruption, despite the COVID-19 pandemic. Currently, we are preparing for the next steps of the study start-up process including Investigational Drug Import License application, Local Ethics Committees submissions, and finalization of clinical trial agreements with sites.
Dr. Selivra, GCT CEO, expresses his gratitude to the team for all their hard work and dedication in achieving this important study milestone during these challenging times.
Updated: April 15, 2020
GCT is conducting a Phase II multi-center, double-blind, placebo-controlled dose-ranging study in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in Poland, Hungary and Germany.
Subjects will be randomized to one of the 3 treatment groups. The active treatment groups receive one of the two doses of the study drug with three loading doses of anti-VEGF treatment. The placebo treatment group receives anti-VEGF treatment per label for the duration of the study.
The project aims to assess the effects of the study drug on visual acuity and is sponsored by a US based biopharmaceutical company dedicated to developing treatment options for age-related diseases.
GCT is responsible for management of the study globally. Besides Clinical, we provide a comprehensive list of services including Data Management, Biostatistics, Safety, Medical Monitoring, Concomitant Drug logistics and Study Legal Representation in the EU.
Updated: April 10, 2020
GCT has been selected for eTMF setup and maintenance for a clinical study in the US and rest of world (ROW). GCT will perform activities to ensure a smooth merge of the TMF between US sites and ROW. The Phase I/II study has been ongoing in the US for over five years in 45+ sites. At the time, a paper TMF was implemented, however the Sponsor would now like to transition the paper files to an eTMF.
Our team will transfer the files from paper TMF to eTMF to ensure an audit ready Trial Master File. We will check that all files were correctly maintained to identify and resolve any issues. GCT’s responsibilities include but are not limited to maintaining electronic files and original paper copies – where necessary, related to study sites and to third-party vendors contracted by GCT, as well as study-related regulatory Essential Documents and safety-related documentation. The GCT team will be responsible for obtaining, collecting, labeling and filing all documents in the eTMF following an initial QC. Our Project Manager will be also responsible for the regular review of the TMF content.
Once study documents are uploaded to the appropriate section of eTMF, they will be kept in a secure area with limited access. All documents will be readily available and directly accessible for audit purposes.
The selected eTMF system is fully validated and meets compliance with 21 CFR Part 11 and other global regulations. It is available 24/7 from anywhere in the world. Having an eTMF ensures constant inspection readiness by means of automated folders completeness statistics, missing documents reports and various notifications. The validation process is based on GAMP methodology. Fundamental to successful validation technical security and 21 CFR Part 11 required controls are implemented in the system.
Updated: April 6, 2020
During these challenging times, it is important for us to do everything we can to ensure the safety of our patients and the continuity of all ongoing projects. GCT remains fully operational during the outbreak with our employees available in the USA, Europe, and Asia. We are conducting business as usual while adapting, as needed in these unusual and unprecedented circumstances.
We are closely monitoring government regulations and guidelines to stay compliant and help slow the spread of COVID-19. GCT is following the latest recommendations issued by the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). We are working to proactively assess each study’s needs in this fluid situation to keep to our client’s timelines and goals.
I would like to thank our partners for their trust in us and our employees for their dedication. Please do not hesitate to reach out to us with your questions and requests – we remain open and at your disposal.
Eugene Selivra, MD
Chief Executive Officer
Global Clinical Trials
Updated: March 24, 2020