Meet GCT at ISCR Summit

Meet GCT team at the ISCR Conference next week in Mumbai! – https://www.iscr.org/iscr-conference-2020/

January, 24-25, GCT CEO, Dr. Eugene Selivra, Country Director, Dr. Umakanta Sahoo and Senior Director of Business Development, Nataliya Katsnelson will be at the summit, which is devoted to bringing together the global and local clinical research community.

To schedule a meeting, please contact us at BD@GCTRIALS.COM.

We look forward to seeing you there!

Thyroid Awareness Month

The thyroid gland is a gland located in the lower front of the neck. It produces thyroid hormones, which are then secreted into the blood and transferred around the body. These hormones are responsible for coordinating many important processes within the body, for example, controlling the body temperature and heart beat.  Hence, when the thyroid gland doesn’t function properly, it can result in serious conditions.

The two main types of conditions are Hyperthyroidism and Hypothyroidism. When they occur, the thyroid gland produces too much and too little hormones, accordingly. However the symptoms can be vague – weight loss/gain, depression and fatigue.  It is necessary to take a blood test in order to understand how well a thyroid gland works. If a dysfunction is detected, there are a few treatment options available from medications to surgery.

Happy Birthday to Karina Osmanova!

January 11th was the birthday of Karina Osmanova, our Office Manager, and we are having a celebration today at our St. Petersburg office!

All of us at GCT wish for all Karina’s dreams to come true this year.

Happy Birthday, Karina!!

Glaucoma Awareness Month

Glaucoma is one of the leading causes of vision loss for people over 60 years old. There are no early symptoms, and nearly half of the people who have glaucoma are unaware of it.

Glaucoma is a group of diseases that affect the optic nerve, a part of the eye that is responsible for transmitting signals from the eye to the brain. When the fluid in the eye doesn’t drain properly, the pressure within the eye increases. It damages the optic nerve and leads to partial or complete vision loss.

As the eye pressure can change throughout the day, a single visit to the ophthalmologist often isn’t enough to detect the disease. This is why it is necessary to have regular eye exams. Depending on the type and severity of glaucoma, several treatment options are available to patients today including eye drop medications and surgery.  Even though the loss of vision due to glaucoma is irreversible, treatment helps stop the progression of the disease.

GCT has conducted a number of studies in glaucoma and other eye diseases. Currently we are managing a phase III trial in ocular hypertension or primary open angle glaucoma. We are hopeful about further development of the treatment options’ efficacy.

 

Happy Birthday to Csilla Leka!

The New Year has begun, and we have our first GCT employee Birthday to celebrate today!

Csilla Leka is General Director of our office in Hungary, and she has also been a project manager since 2016. We admire Csilla for her hard work, willingness to help out and work ethics.

Wishing Csilla all the best on this special day!

Happy New Year!!

Happy New Year to All our Friends and Partners!!

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.

Happy Birthday to Anton Romanov!

It is a special day at GCT Russian office as we are celebrating yet another birthday of our oldest employee. On December 20th we wish Happy Birthday to Anton Romanov, M. Sc. GCT Event Manager.

All the team wishes Anton luck, health and another year of unforgettable memories and adventures!

Dr. Sahoo at 14th Biosimilars Congregation in Mumbai

Among the discussed topics of the 14th Biosimilars Congregation in Mumbai were the regulatory updates, present state of the biosimilars market, product development strategies, challenges, and many more. Dr. Umakanta Sahoo, GCT Managing Director in India was there to examine the latest trends in the biosimilars drug development field together with the industry experts. The meeting was truly insightful and turned into a major international networking platform.

GCT President at CTAD and ACNP meetings

GCT President, Dr. Jeffrey Apter has recently attended two major conferences on brain health and Alzheimer’s. CTAD (Clinical Trials on Alzheimer’s Disease) took place in San Diego, 4-7  December. The attendees discussed the development of the next generation of the Alzheimer’s Disease treatments. It was followed by the ACNP (The American College of Neuropshychopharmacology) 58th annual meeting in Orlando, FL on 8-11 December, and focused on brain behavior-drug interactions and most recent advances in psychopharmacology.

Both meetings were highly successful and informative, and offered a great networking opportunity.

14th Biosimilars Congregation 2019 in Mumbai

If you are joining us at the 14th Biosimilars Congregation 2019 in Mumbai, please do not hesitate to email bd@gctrials.com to schedule a meeting.   Dr. Umakanta Sahoo, GCT-India Managing Director, will be there at the conference and will be glad to discuss the aspects of planning a successful clinical trial India, Eastern Europe, Russia and the US. The conference takes place on the 12th of December at Kohinoor Continental Hotel, and its focus is on the development, manufacturing and commercialization of biosimilars.

 

Happy Birthday to Daria Podgorska and Roxana Darie!

    

Today is a special day in the GCT calendar as we are having a double-celebration. On December 9th we wish Happy Birthday to Roxana Darie and Daria Podgorska, GCT Managing Directors and Project Managers in Romania and Poland.

We hope this year holds many wonderful moments and exciting events for Daria and Roxana.  All of us at GCT are honored to have these two wonderful ladies as our colleagues.

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.

5k Turkey Trot 2019

What is the best way to start a Thanksgiving day? We say it’s running a 5k Turkey Trot!

Nataliya Katsnelson and Elizaveta Medvedeva ran a 5K cross country course promoting healthy holiday habits.

We are definitely doing this again soon and hope you can join us! An energy boost and much fun are guaranteed, even if it seems a little windy and and cold at the beginning.

Happy Birthday to Veronika Goriachikh!

29th of November we celebrate the Birthday of our Head of Logistics, Veronika Goriachikh. Thanks Veronika from all of the GCT global team for your hard-work and always being ready to go an extra mile. May today be filled with joy and happiness, and the year offer you plenty of opportunities for success and many more great memories! Happy Birthday, Veronika!

 

Happy Thanksgiving!

Wishing a beautiful holiday season to everyone!

Adaptive design in clinical trials trend

A failure to determine the appropriate dose of a drug for clinical use is the leading cause of FDA non-approvals. Thus, the FDA and EMA have been becoming more and more supportive of Adaptive Design in clinical trials. It has now become a recommended strategy for conducting dose ranging trials.

Sponsors get advantage of the decreased cost and improved chances of the positive outcome of a study, while the patient safety also improves. Adaptive Design allows for more flexibility, which, in turn, helps avoid repeated clinical trials. Not only is it extremely cost-effective, but also much less time-consuming. So the investigated drug can potentially be brought to the market faster. It is both beneficial for patients, and can increase return on investments. Moreover, Adaptive Design improves risk management. It makes it possible to indicate failure on earlier stages due to interim data analyses. Furthermore, it offers an even more significant advantage – improved patient safety. Due to the reasons mentioned above, fewer patients in Adaptive Design clinical trials are assigned unsafe or/and ineffective doses of the drug. All of these aspects lead to the Adaptive Design gaining popularity.

Adoptive Design is a strategy that can make a clinical trial go smoother and faster. However, the sponsor and the CRO must design detailed SOPs and specific work practices carefully in order to be able to perform it. Data driven monitoring and integrated IT platform and software must also be implemented. While it can come with its own challenges, Adaptive Design in clinical trials proves to be effective in many cases and speeds up drug development.

World Pancreatic Cancer Day

There are several types of pancreatic cancer, depending on whether the cancer began in the exocrine or endocrine component. Pancreatic cancer is often difficult to diagnose due to the lack of symptoms until a later stage. However, as the cancer begins to grow, patients suffer from pain in the upper abdomen, loss of appetite and weight, yellowing of the skin and eyes, weakness and depression.

The risk of Pancreatic Cancer increases with age, and men are more prone to the disease than women. Other factors include family history of pancreatic cancer, smoking and unhealthy diet. In order to reduce the risk of pancreatic cancer, doctors advise exercising, maintaining a healthy weight, consuming less red meat and more fruits and vegetables.

Numerous clinical studies in Pancreatic Cancer are currently being conducted. They aim to improve the treatment safety and efficacy as well as the number of options available to the patients.

GCT has been supporting oncology clinical trials since 2001. We are excited to see the progress that’s been made in cancer treatment, and we hope to see more promising trial results in the near future.

 

Happy Birthday to Victor Litvinskiy!

Saturday, November 16th our colleague Victor Litvinskiy celebrated his Birthday. Victor joined GCT as a CRA couple of years ago, and has since become an irreplaceable part of our global company. All of us here at GCT wish Victor a splendid year ahead, many new travels and success!  We are proud to have such a wonderful and dedicated colleague in our team.

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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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