New Phase I Breast Cancer Study Awarded in Russia

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).

Chronic Pancreatitis Study: First Patient In (FPI)

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.

GCT to Conduct a Rare Pulmonary Disease Study

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.

Multinational Natural History Rare Disease Study Extension

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.

COVID-19 study to be conducted in Russia and Ukraine

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.

GCT supports the White Nights Ophthalmology Congress going virtual

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

Multisystem Rare Disease Study in India

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.


Sponsor Audits Passed Successfully

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. 

Regulatory Approval Granted for Chronic Pancreatitis Study in Russia

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.

Enrollment Commences for Phase II Ophthalmology Trial in Europe

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.

GCT to perform eTMF merge in the USA

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.

A message from Global Clinical Trials LLC about the operations during COVID-19 Pandemic

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.

Best Regards,

Eugene Selivra, MD

Chief Executive Officer

Global Clinical Trials

GCT Awarded a Rare Genetic Epilepsy Study in Pediatric Patients

A new Neurology Study has been awarded to Global Clinical Trials. It is a trial for children living with a rare epilepsy syndrome characterized by seizures and cognitive delays. The condition is due to a mutation of a gene on the X chromosome.

This study will be managed at several Russian sites by GCT. We will perform a wide scope of services including all the activities associated with the project management, monitoring and logistics. Presently, the trial is in the active start-up phase. We look forward to reaching the first study milestone.

Enrollment Completed by GCT for POAG study

Enrollment goal was reached for the Phase III study in ocular hypertension or primary open angle glaucoma managed by GCT. POAG is a serious condition in which the measured eye pressure is consistently greater than normal, which leads to optic nerve damage and vision loss.

The trial designed as a multicentre, randomised, cross-over type and is conducted in Russia. The regulatory approval was obtained in the minimal period of time, which helped to meet the Sponsor’s timelines. All patients are enrolled in the trial now, and the treatment phase will continue per protocol. GCT looks forward to facilitating the achievement of the next milestone for this study.

New OB/GYN Study in Ukraine

GCT has been awarded a new randomized, double-blind, three-arm, parallel-group, multicenter superiority study in Ukraine. The goal of the trial is to assess the efficacy and safety of the drug in women suffering from endometriosis. This is a global study currently run in more than 5 countries. In Ukraine alone GCT will enroll 150 patients at 11 investigational sites.

For this project, GCT is responsible for the wide range of services including the regulatory support, site management, remote and on-site monitoring and the full cycle logistics management of the IMP, lab kits and biosamples. The project lead in Ukraine is Dmytro Mnozhynskyy, MD; he has more than 15 years of experience in clinical trials. Having successfully managed numerous women’s health clinical trials, GCT will transfer the accumulated expertise for the smooth and timely study completion.

GCT Expands Operations to Kazakhstan

Oleg Kurilov, MD – GCT General Director in Kazakhstan

As 2020 begins, GCT expands its operations in Asia, adding the Republic of Kazakhstan to its map. Dr. Oleg Kurilov is appointed the GCT General Director in Kazakhstan. He specializes in surgery, urology and nephrology and has a broad expertise working in clinical trials.

Located in Central Asia, Kazakhstan has a population of over 18 million people. It is the world’s largest landlocked country and the ninth largest country in the world. Kazakhstan is part of The Eurasian Economic Union (EAEU). Among many economic and political areas, the union regulates and unifies the pharmaceutical and clinical trials industry. This includes an easier registration of drugs and medical devices, accelerated approval timelines, and a simplified customs and logistics process in other member countries. These advantages make Kazakhstan attractive for both regional and global companies.

In December 2019, the government of Kazakhstan approved the state program for the development and improvement of the country’s Healthcare System for 2020-2050. A significant part of the program is devoted to increasing the number of clinical trials and bringing international clinical trials into the country. Currently, it takes 1 month to receive the approval for a clinical study from the Regulatory Authority. The submission to the Ethics Committee is performed in parallel. This allows study sites to open in just 1.5 months, providing no questions are raised by either authority. It is also worth to mention that all regulatory documentation can be submitted in the Russian language.

“Providing the high quality clinical trial services is always our top priority, and expanding to new regions enhances our operational capabilities. Kazakhstan is a rapidly developing country that is fully compliant with GCP. It is a great option to consider Kazakhstan for a global study to have a diverse patient population and fast enrollment. We are excited to offer this new region to our clients,” – GCT CEO, Dr. Eugene Selivra.

End of Enrollment for Pediatric Phase III Trial

GCT has successfully concluded enrollment for the Phase III pediatric study of rare neurological disease in Russia. Reaching the exact recruitment number, as predicted and in under 1.5 months marks an important milestone for our company and the Sponsor – US Pharma and GCT long term partner. Together, we were able to meet the projected deliverables despite the demanding timelines, sensitive patient group and limited number of sites that treat this devastating condition in Russia. The treatment phase of the study is now well underway according to the protocol schedule.

Phase IV Study in Russia Awarded

GCT is awarded a phase IV study to compare the efficacy and safety of two methods of IP administration in patients with acute sore throat. GCT will be managing study in Russia with aim of enrolling up to 160 patients. Apart from clinical monitoring and site management, GCT will be responsible for the full regulatory support and drug importation. The project is currently in the active start-up stage.

It’s the Holiday Season across the globe…

GCT Photo Collage 2019

… and at this special time of year, we are looking back with appreciation to our partners and friends for their ongoing support. Our global team feels grateful for your trust and loyalty, as we invite you to reflect on the 2019 together with us. Thank you for the opportunity to serve you and work with you. We wish you all the best as you embark on 2020!

From all of us at Global Clinical Trials

(more…)

Investigator Meeting held for study in Chronic Pancreatitis

Last month, GCT held the Investigator Meeting for the gastroenterology project sponsored by a U.S. Pharma company. The event took place in Warsaw, Poland with 100% attendance from all the 20 Ukrainian and Russian sites. Recruitment is planned to open shortly after the first regulatory approval is received.

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We are a full-service clinical development provider, offering feasibility analysis, regulatory submission, site selection, project management, monitoring, data management, logistics, and more.

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