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.

Project in Czech Republic Awarded

Global Clinical Trials was selected to provide intense monitoring support for a 3-week study in Czech Republic. Not only did GCT organize the study handover within a week, but also proposed a CRA with relevant and comprehensive experience. Specific CRA expertise is a crucial requirement for the monitoring of the in-vitro diagnostic device trial that will be performed at a specialty lab in Prague.

Investigator Meetings recently held by GCT in Europe

Two investigators meetings were organized to support the start-up of the projects awarded to GCT. The first one took place in Warsaw, Poland, and gathered over 20 sites from 3 European countries for the Phase II Ophthalmology study discussion.

The second was organized in Saint-Petersburg, Russia in early October, and was devoted to the training of sites personnel involved in the pediatric Phase III trial in patients with a rare neurological disorder.

Both studies are in the active start-up.

Approval Received for Clinical Study in Romania

This month, an approval was granted by Romanian National Agency for Medicines and Medical Devices to conduct the study in patients with inoperable liver cancers non-responding to standard therapy. Promising research is being carried out by GCT team in Romania and sponsored by a EU based company. The patient enrollment is expected to start shortly following the Investigator Meeting in Bucharest.

GCT has an extensive Oncology expertise in EU, Russia, Ukraine and USA, and this project is another opportunity for the company to enhance it.

Pictured: Monument of Rebirth in front of the MOH building in Bucharest, Romania, image courtesy by Dennis Jarvis under CC BY-SA 2.0

New office in Hungary

GCT Hungarian team had their first day working at the new office yesterday. Due to the continuous growth in operations and the number of employees, GCT decided to move to a larger, more comfortable facility.

Our new location is:

Fehérvári út 44.,
1113 Budapest

Congratulations to our colleagues in Hungary, and hope you are enjoying the new place!

 

MOH approval received for Rare Genetic Disorder study in Russia

The regulatory approval to conduct CNS Pediatric study in Russia was received by GCT in under 60 days.

This Phase III study in children and young adults with a rare genetic mutation in the X-chromosome was awarded to GCT earlier this year. Study aims to recruit up to 20 patients with this rare and debilitating disease in Russia alone. GCT is responsible for the site management, providing the full service clinical operations support, logistics and regulatory services.

On average, regulatory approval in Russia may take 3 – 3,5 months. We look forward to the first site initiation for this significant and exciting project.

New office in Poland

As our coverage grows and our local teams expand, Global Clinical Trials office in Poland has moved to a new, larger location on Wednesday, 28th of August 2019.

The new address in Poland is:

Mlądzka 10, 04-136

Warsaw

We look forward to new changes and congratulate our colleagues in Poland on the exciting news!

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GCT is a CRO experienced in performing clinical research in the USA, Europe, Russia and India.

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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