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.

Clinical Trials Day

Congratulations to all colleagues involved in drug development! GCT also expresses gratitude to patients all over the world participating in clinical trials. Without them, providing safe and effecting medication would be impossible. We are proud to be part of this global community driving clinical research forward.

Mental Health Month

Always an important subject, Mental Health is crucial during the time like this. May is the Mental Health month, and we can’t underestimate the immense of an effect it can have on our well-being.

In order to reduce stress and anxiety, and adapt better to social distancing, we need to take greater care of ourselves. This can include putting extra effort into keeping a healthy diet, practicing various types of meditation, exercising and connecting with others via the means available. Find out what works best for you. If you are struggling to maintain a positive perspective, be sure to reach out for support.

Mental Health affects each aspect of our lives, including work and family relations. That is why we should do our best to minimize the negative outcomes of the circumstances we deal with today.

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. 

Meet GCT at the COVID-19 Virtual Partnering Conference

GCT is participating at the COVID-19 Virtual Partnering Event to be held on 4-6 May 2020! We can’t wait to meet with potential partners in development of treatments for COVID-19. GCT is a full-service CRO offering clinical trial solutions in the USA, Europe and Asia.

If you are attending, please look for Global Clinical Trials at the Inova partnering platform and request a meeting. Look forward to meeting you online!

World Intellectual Property Day

Clinical Research performs a vital function of generating new drugs for the market. However, the process is not only extremely complex and lengthy but also very costly. Drug development relies on the Intellectual Property Rights laws, which are strictly guided and foster the further advancement of the industry.

Happy Birthday to Dmytro Mnozhynskyy!

General Director of GCT Ukraine operations, Dr. Dmytro Mnozhynskyy is celebrating his birthday today. Dmytro has been an irreplaceable part of our global team for more than a decade. All of us at GCT are lucky to work alongside Dmytro, who brings his professionalism, experience and positive attitude to our daily work.

We hope you have a wonderful day and a great year ahead! Happy Birthday!

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.

April: Cancer Control Month

April is the Cancer Control Month, so let’s raise awareness together. Cancer is the second leading cause of death globally with lung cancer being both the most common and deadly type.

Sometimes cancer can be hard to diagnose. However, leading a healthy lifestyle can lower the risk. The major risk factors are poor diet, tobacco and alcohol use and physical inactivity. Keeping a healthy diet and doing exercise regularly is an effective way to keep your immune system strong and lower the chances of getting cancer.

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.

World Health Day

World Health Day is a great opportunity to emphasize the importance of global health and functional health systems available all over the world.

Today we would especially like recognize the hard work that nurses and midwives do for our global community. Their devotion and courage is inspiring, and the daily work they perform is truly irreplaceable!

At these times, we hope that everyone is staying healthy and doing everything in her or his power to keep the community safe.

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.

Happy Birthday to Irina Ryzhkova!

Saturday, April 4th Irina Ryzhkova, GCT Deputy Director and Corporate Lawyer celebrated her birthday!

Irina has been with GCT for over 8 years now. We feel very lucky to have her on our global team, and we wish her a happy year full of accomplishments and beautiful memories!

National Doctors’ Day

A huge THANK YOU to all the doctors for their dedication and daily hard work! We are lucky and grateful for your professionalism and care.

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.

Happy St. Patrick’s Day!

We hope you enjoy your St. Patrick’s Day!

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.

Happy Holi!

Happy Holi to the colleagues from our Indian Office today. We hope everyone is having a fantastic day of celebration!

Dr. Apter at GAP Foundation

GCT President, Dr. Jeffrey Apter recently participated in the Global Alzheimer’s Platform Foundation event. The Site-Optimization Conference took place 26-28 of February in Orlando, Florida. It is a great platform for sharing knowledge in Alzheimer’s research among the renowned researchers, sponsors and other industry professionals.

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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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