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).

Happy Birthday to Natalia Isachenko

Yesterday, Natalia Isachenko, M. Sc., GCT financial manager celebrated her birthday. Natalia has been part of the global GCT team for 4 years, and this year she became a mother to a wonderful girl. We are very proud to have Natalia on our team and impressed by the ability to balance life and work.

Dear Natalia, we hope that the year ahead is happy and healthy, and brings you a lot of success!

June 28th: World Hepatitis Day

Viral Hepatitis, a group of diseases known as hepatitis A, B, C, D, and E, impacts more than 325 million people worldwide causing about 1 million deaths annually. The outcomes of the disease may include acute and chronic liver disease, sometimes leading to severe symptoms, development of liver cancer or even death. Today we have vaccines for hepatitis’ types A and B. Treatment options are available for the other types of hepatitis, and their effectiveness relies heavily on the timely diagnosis of the disease.

Depending on the type, hepatitis can be transmitted through sharing needles, close contact, contaminated food and water and from mothers to newborns. This year’s theme is “Hepatitis-free future” focusing on prevention of the infection among mothers and newborns.

International Group B Strep Awareness Month

As a company that has been conducting numerous clinical trials in infectious diseases and women’s health, we want to spread awareness about the Group B Strep Throat Disease.

The disease mostly affects babies and is often transmitted from the mother through the digestive tract and birth canal. It can cause miscarriages, premature birth, lifelong handicaps or death in babies up to 6 months old. The symptoms can be very severe and include fever, lethargy, difficulty breathing and others.

By promoting awareness, we aim to prevent as many cases as possible.

Sarcoma Awareness Month

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.

UV Safety Awareness Month

Exposure to UV (ultra-violet)-radiation is the cause of most skin cancers. Please stay sun-smart while enjoying this wonderful summer weather!

Here are some helpful tips that will help you protect your skin: https://gctrials.com/posts/july-is-uv-safety-month/

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.

Maria Bogdanova’s Birthday

Yesterday we celebrated the birthday of Maria Bogdanova, our Clinical Research Associate (CRA) in Bulgaria. Maria has been our colleague for over 4 years now, providing us with quality support of clinical trials. All of us here at GCT are thankful to have Maria on our team, and we wish her much happiness and success. Happy Birthday!

Happy 4th of July!

Happy Independence Day, USA!

June is Cataract Awareness Month

June 2020: Cataract Awareness Month

June is Cataract Awareness Month. Cataract is a common eye disease and is the leading cause of blindness in the world. Cataracts are a clouding of the eye’s lens, which prevents the light from passing into the eye. Most often, cataracts affect people older than 40; family history of the disease and smoking can increase the risk. The disease is very prevalent, but it’s manageable and can be treated easily with a surgery.

GCT is an exclusive information partner of the annual international Ophthalmology congress, “White Nights” held in St. Petersburg, Russia. Having conducted numerous clinical trials in Opthalmology, including the ones in patients with cataracts, we hope to help spread awareness about this disease and encourage patients to seek medical treatment.

Dr. Irina Golovacheva’s Birthday

Dr. Irina Golovacheva, GCT Deputy Director, Regulatory Affairs in Russia celebrated her birthday on June 28th. Irina has been doing an excellent job performing the regulatory submissions and coordinating the smooth approvals for every trial conducted by GCT in Russia for over 7 years.

May your year be happy and your dreams come true. We are sure that many new personal and professional accomplishments are awaiting you. Happy Birthday, Irina!

Dr. Vladimir Seredyuk’s Birthday

On June 27th Dr. Vladimir Seredyuk celebrated his birthday. Dr. Seredyuk has been with GCT for over 6 years fulfilling the role of the Quality Assurance Director. Our global team is grateful to have such a reliable and professional colleague with diverse experience in clinical research. Happy birthday, Vladimir! We wish you a lot of happiness and success in the new year.

June is the PTSD Awareness Month

7%-8% of the world’s population will suffer from PTSD at some point in their life. Post Traumatic Stress Disorder (PTSD) affects many people who have experienced a scary or shocking event. People with PTSD feel stressed and/or afraid even a long time after the event has happened and when they are not in danger any more. For the first time, PTSD symptoms may occur months or years after the traumatic experience.

Do not hesitate to ask for help if you believe that you or your loved ones might suffer from PTSD. Luckily, today there are a number of treatment options available including different kinds of psychotherapy and medications.

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.

Eurasia Pharmaceutical Forum: Clinical Trials in the Eurasian Region

Yesterday, June 16th, GCT Director of Business Development, Aleksandr Stiblo, took part at the virtual Eurasia Pharmaceutical Forum dedicated to the Clinical Research in the region.

The Forum proved to be a useful platform for the discussion of the changes in the organizational process of clinical trials due to COVID-19 pandemic. For instance, regulatory and industry professionals from leading investigational sites and pharma companies shared their experience in managing COVID clinical trials and trials of other indications during the pandemic. They talked about further implementation of remote SDV and SDR, ePRO and eCOA, home visits, logistics of IMP directly to patients. While the scope of off-site activities are increasing, data protection aspects as well as GDPR for EU companies working in Russia have been also discussed during the 2h session.

This virtual event was a great place for obtaining and sharing insightful up-to-date information, which is absolutely vital to connect with industry colleagues during these unprecedented times.

DIA 2020: Virtual Conference

GCT is exhibiting at the DIA Virtual Conference June 14-18, 2020!

DIA has provided the world’s largest global stage for life science professionals to come together to address healthcare challenges and discuss future of public health, and how it is impacted by advanced technology and science.

Join GCT BD team in the US, Elizaveta Medvedeva and Nataliya Katsnelson at the DIA — click Connect with Representative in the exhibits section https://diagam20.stage.onlineeventapp.com/exhibitors/11EAA6BECBA61E00960AAFDA20A63460/Global-Clinical-Trials-GCT.

Pharmaceutical Market in Belarus: work in the situation of world pandemic

Aleksandr Stiblo, GCT Director of Business Development, attended an online conference, one of the series of online events “120 minutes with Advantix Pharma”, dedicated to the Belarusian pharmaceutical industry.

While the global pandemic has affected pharmaceutical industry across the world, Belarus is finding new strategies of optimizing its work and coping with challenges. During the conference, changes in drug registration process, shifts in demand and pricing, new regulations in drug manufacturing and marketing were discussed.

If you are looking to conduct a clinical trial in EAEU region, including Russia, Kazakhstan and Belarus – contact us at bd@gctrials.com for support.

June 2020: Myasthenia Gravis Awareness Month

Myasthenia Gravis is an autoimmune neuromuscular disorder  characterized by double vision, drooping eyelids, trouble talking and skeletal muscle weakness. It affects women more frequently than men. The symptoms usually peak in women during their 20s and 30s, in men – during their 50s and 60s.

Presently there is no cure for Myasthenia Gravis. However, the available treatments let most patients manage the symptoms effectively, lead normal lives and have a normal life expectancy.

Myasothenia Gravis Awareness month is organized by Myasthenia Gravis Foundation of America, Inc. and observed annually. Due to the increase of awareness, many more patients have been diagnosed with the disease and were able to receive treatment in the recent years.

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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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