Happy Birthday, Natalia!

This Happy Monday feels much more cheerful as it is the birthday of GCT Financial Manager, Natalia Krupina.

Natalia has been working at GCT since 2016, and all these years she has been such a reliable and professional colleague for all of us.

We all are incredibly lucky to have her on the team.

May your life be full of beauty and happiness! Happy Birthday!

Employee Story: Elizaveta Medvedeva

Which office are you located at? What can you say about US involvement in clinical trials?

I am based in Princeton, NJ at GCT headquarters. In recent years, we have been growing our operations in the US and adding more full-time personnel here. Many of our clients are U.S. companies, and the studies often involve clinical sites in the U.S., or they are US-based entirely.

How long have you worked here? Can you talk more about your role?

I will have been with the company for 3 years this coming November. Being a part of the Business Development team has been an extremely fulfilling experience because this job combines so many responsibilities. Most of them revolve around communicating with sponsors, developing business proposals, and looking for new opportunities. Not one day has passed without me learning something new.

Was the job what you expected it would be? Did anything surprise you?

I was prepared for the job to be very different from what I had done before, so there was no shock. Though, the immense amount of information I learned affected my understanding of the pharmaceutical industry. I was amazed at how professionals with very different cultural backgrounds and expertise communicate and collaborate effectively in the field of clinical trials.

What has changed at the company since you joined?

These past couple of years have kept our team busy and excited. Since 2018, GCT has expanded its physical coverage, adding Georgia, Kazakhstan, and the Baltics to the map. We now offer data management and biostatistics services in-house. Dozens of new projects, both global and local, have been added to the portfolio, as we continued to develop partnerships with both the sponsors and other service providers across the globe. Though, it is important that despite all the inspiring transformation, the core values of the company, such as our flexibility and professionalism remain the same.

What is important for you at GCT?     

I am grateful for the internal culture of the company. The support of my colleagues both from the Business Development department and from across the company has been invaluable.

Can you describe an event that was particularly memorable during your career at GCT?

The very first corporate Christmas party I attended in St. Petersburg, Russia was a highlight. ­It lasted past midnight, with all the employees having so much fun and celebrating the end of the year. There were music, dances, and games. Everyone was enjoying it.

What was the moment when you knew you’d made the right decision to join GCT?

The very first corporate party? 😊 When I received the job offer, I did not hesitate to accept it, and my expectations were exceeded since day one. It was clear how much new rewarding experience the job had to offer.

What do you think the mission of GCT is?

The primary mission of the whole industry is to develop and deliver the most effective and safest drugs possible to those in need. As a Contract Research Organization, we do our part in organizing the process of conducting clinical trials smoothly and effectively.

Describe GCT in 3 words

Expert, flexible and global.

How do you see GCT in 10 years?

I enjoy that GCT has a long-term development strategy, but also utilizes the opportunities that might arise along the way — our quality of being flexible. I would like to see the company continuing to grow its presence in the US, but perhaps extending its reach to new countries or even continents as well. We will see!

Lessons learned in 20 years

Focus on the people, and the company will succeed

How is the company doing with people, processes? It is important to ask these questions to make sure that you are not just fixated on a company or brand development.

GCT provides comprehensive clinical research solutions, and the core services are monitoring and project management for clinical trials. These services are supported by the people, so it is crucial to listen to the feedback of the employees.

GCT team sets aside time regularly to assess and discuss what can be changed or improved. This is an investment in the future of the company. When the team is working properly inside, there is a much higher chance that the outside expectations will be met.

Time is a valuable resource

Time management becomes a crucial skill when running a global company. Many business owners will agree that there are not enough hours in a day.

Here are two tips that we have found helpful:

  1. Prioritizing. Sometimes the choice is hard. However, it is important to determine what aligns with the company’s long-term strategy and make the decision according to it.
  2. Delegating. Trust the local employees to do the job. Giving them the freedom to make decisions, while providing oversight and support has proven to be the most effective and time-saving method of management.

#WorldHepatitisDay

World Hepatitis Day is observed annually on July 28th to increase the awareness of viral hepatitis.

Viral hepatitis is an infection that causes liver inflammation and damage.

There are five main strains of the hepatitis virus — A, B, C, D, and E. Together, Hepatitis B and C are the most common, causing 1.1 million deaths and 3 million new infections each year.

Common symptoms of hepatitis are:

  • fatigue
  • Flu-like symptoms
  • dark urine
  • pale stools
  • abdominal pain
  • loss of appetite
  • unexplained weight loss
  • yellow skin and eyes, which could be a sign of jaundice.

The ways to prevent or reduce the risk of having hepatitis vary depending on the type of the virus. There are vaccines available to prevent hepatitis A and B. Autoimmune hepatitis cannot be prevented.

The risk groups for viral hepatitis B and C include healthcare professionals, people with multiple sexual partners, and intravenous drug users. Blood transfusion is a rare cause of viral hepatitis.

July is Sarcoma Awareness Month

Sarcoma is a type of cancer that can occur in various places in your body.

Sarcoma is a general term for a wide group of cancers that grow in the bones and soft tissues. Soft tissue sarcomas form in the tissues that connect, support, and surround other body structures.

People who have been affected by a high dose of radiation for the treatment of other types of cancer, such as breast or cervical cancer, have a slightly higher risk of developing soft tissue sarcoma. In general, routine X-rays and diagnostic tests do not increase the risk of developing soft tissue sarcoma.

Unfortunately, there is no test that can detect sarcoma cells when they are just beginning to grow. However, a patient has a better chance of surviving if a soft tissue sarcoma is detected and treated at an early stage. The treatment depends on the type of this disease.

Ultraviolet Safety Awareness Month

July is ultraviolet (UV) safety awareness month.

UV rays are an unseen form of radiation that comes from the sun, tanning beds, and sunlamps.

It is crucially important to protect your eyes because they are exposed to UV rays all year round. They can penetrate, and change skin cells. Unprotected sun exposure can lead to premature skin aging, vision issues, and skin cancer

Here are some tips that will help you reduce the damage of UV rays:

  • Select sunglasses that block UV rays (Check for 100 percent UV protection)
  • Put on sunscreen
  • Wear proper clothing (long-sleeved shirts, pants, hats)
  • Never look directly at the sun

GCT is an expert in ophthalmology and oncology clinical trials. Let us know at bd@gctrial.com if you need more information about our experience.

Happy Birthday, Agnieszka Hareza!

Yesterday we all celebrated Agnieszka Hareza’s birthday. Agnieszka is a Clinical Research Associate at Global Clinical Trials.

May your birthday be the start of the year filled with good luck, good health, and much happiness. Happy Birthday!

July is Juvenile Arthritis Awareness Month

Juvenile arthritis is a condition in which the inflammation (swelling) of the synovium happens. The synovium is the tissue lining the inside of the joints.

The disease usually affects children aged 16 or younger and has a physical and emotional impact on them, often leading to debilitating pain and feelings of loneliness or depression.

There is no cure for Juvenile Arthritis, however, with the help of medicines and special therapy affected children can:

  • relieve pain
  • reduce swelling
  • increase joint mobility and strength
  • prevent joint damage and complications

GCT has solid experience in pediatric studies, please reach us at bd@gctrilas.com for more information.

Happy Birthday, Vladimir Khromenko!

This past Monday we celebrated the birthday of one of our valued colleagues, Vladimir Khromenko, GCT Clinical Research Associate based in Russia.

Although Vladimir has only recently joined the company, his enthusiasm and desire to contribute have helped him adapt very quickly.

GCT global team wishes you a festive and productive year ahead!

First Patient In Endometriosis Clinical Trial in Ukraine

Global Clinical Trials announces the first successful screening in the endometriosis study.

It is a Phase III double-blind, three-arm superiority study in 200+ subjects that is being conducted in Ukraine. The study aims to assess the safety and efficacy of the Investigational Product (IP) for treatment of endometriosis in women of reproductive age.

GCT has been running Women’s Health clinical trials since 2001, and it is one of GCT’s main–focus therapeutic areas. GCT is well–familiar with Key Opinion Leaders (KOLs) and clinical sites, and utilizes this expertise to ensure an effective enrollment of patients for its projects.

“GCT is proud to achieve this milestone in such a short time. Together, GCT, sites, and the Sponsor’s team engaged all their efforts to make it happen, “ said Dr. Eugene Selivra, GCT CEO.

Endometriosis is an incurable but manageable gynecological condition. It occurs when endometrial implants, comprised of tissue normally found within the uterus, are present in other areas of the body. It is a long-term condition that can have a significant impact on the life of the patient.

To plan a new endometriosis clinical trial with GCT, please contact us at bd@gctrials.com.

Happy Independence Day!

Happy Independence Day!

Employee Story: Veronika Goriachikh

When did you join GCT and how long have you been at the company for? Which office are you located at?

I joined GCT in November 2013, so I’ve worked at this company for 7.5 years. I am located at our office in Saint Petersburg, Russia.

Was the job what you expected it would be? Did anything surprise you?

I’ve started my career as a retail pharmacist in one of the biggest pharmacy chains in Saint Petersburg. Handling investigational products, study supplies and equipment and becoming the Head of Central Depot at GCT was an absolutely new experience for me.

What’s changed at the company since you’ve joined?

GCT has expanded geographically. New offices have opened in Europe, India and the CIS countries. Project wise, a number of landmark studies have been performed successfully, including the ones in multiple sclerosis, ulcerative colitis, congenital fibrinogen deficiency.

What is important for you in the corporate culture of GCT? 

GCT is a good place to work. I like the professionalism of my colleagues, friendly atmosphere, good team work, and how our team successfully handles the complicated tasks. I also enjoy our corporate celebrations.

Can you describe an event that was particularly memorable during your career at GCT?

One of such events was my first Sponsor’s audit at the Depot. It was a useful and informative experience for me. Some other ones were my business trip to MeDRA training workshop in Perm, participation in the annual International Ophthalmology Congress “White Nights” and the charity run with my colleagues.

What have you learnt working at GCT?

I‘ve become knowledgeable in GCP, present-day scientific trends in disease treatment, as well as in the logistics field. The later includes understanding deeply the customs requirements and procedures for import of the investigational products and various supplies across different countries; export of biological samples to Central Laboratories outside of Russia.

What do you enjoy the most about your current role?

I enjoy supporting our clinical department organizing clinical studies in Russia.

From your point of view, what is GCT’s contribution to people’s lives? What is the most relevant thing that we do?

GCT is working to advance the health of patients in partnership with pharmaceuticals developers, research institutes and hospitals. Performing high-quality clinical trials can help solve important global health issues, save individual lives, improve the quality of life and the lifetime of patients.

What motivates you to come to work each day?

It is collaborating with others and accomplishing big things as a part of the team and also understanding that my work is important and beneficial.

What are some of your favorite activities outside of work?

I like nature trips and walks in the city. I also enjoy concerts, ballet, photography and painting exhibitions, and of course lectures about medicine and science.

Lessons learned in 20 years

Communicate openly with clients and within the team

Whether it is managing the sponsor’s expectations or resolving a misunderstanding inside the team, straightforward communication is the way to go. Although confrontation might seem like a harder choice, it will likely help avoid escalating the conflict.

We found that it is vital to develop a rapport both with our clients and colleagues, where any issue or problem can be discussed openly. Not only does it facilitate a healthy and productive working environment, but it also helps avoid delays and detours in delivering the projects. Hence, keeping everyone the happiest.

Embrace the change

Comfort zone is something which does not exist in the business environment. Especially, not in the ever evolving and currently booming industry of clinical trials. So, we shall embrace the change!

It can be anything from doing remote visits instead of in-person ones during the pandemic to adding new regions for the project requiring a boost in patients’ enrollment. Staying flexible opens doors and presents new opportunities for growth to us daily.

Irina Golovacheva’s birthday

Today we are celebrating the birthday of our dear colleague, Irina Golovacheva. Irina is the Deputy Director of Regulatory affairs, and has been a part of GCT since 2013.

Wishing Irina a wonderful year ahead with plenty of new memories. We are proud to work alongside you!

Vladimir Seredyuk’s birthday

Yesterday was the birthday of Vladimir Seredyuk, GCT Quality Assurance Director. Vladimir has been with the company for over 5 years now. We are proud to work with such a dedicated professional, who always ready to go an extra mile.

GCT wishes Vladimir a memorable year ahead filled with further professional success and prosperity. Happy birthday, Vladimir!

QP Release – expectations and responsibilities for clinical and commercial drug products in Europe

On June 23rd, the webinar “QP Release – expectations and responsibilities for clinical and commercial drug products in Europe” was held.

Veronika Goriachikh, Head of Logistics at GCT, took part in the event, which covered:

  • Expectations and responsibilities of the QP for release of drug product for clinical trials and commercial supply in EU;
  • Best practices required to efficiently gain QP release – for clinical and commercial products manufactured in North America and other countries outside the EU

and other related topics.

GCT stays up to date with the innovations and changes within the industry, ensuring the highest standard of service for its clients.

Clinical Trials: Science, Global Experience, and Investment in Medicine of the Future

24 June 2021, Global Clinical Trials is participating in the round table called Clinical Trials: Science, Global Experience, and Investment in Medicine of the Future. The event is held in honor of Mikhail Romanovich Lichinitser, the Russian physiologist, oncopharmacology, clinical and fundamental oncology specialist .

During the round table, the most relevant and important issues in Oncology clinical trials will be brought up. The industry professionals, doctors and scientist from various sub-fields will participate in the lively discussion and address these issues. Irina Ryzhkova, Deputy Director of Regulatory Affairs at GCT will be the keynote speaker at the meeting.

Please contact us for more information: bd@gctrials.com

GCT Celebrates 20 Years of Successfully Managing Clinical Trials

http://www.prweb.com/releases/gct_celebrates_20_years_of_successfully_managing_clinical_trials/prweb17993873.htm

PRINCETON, N.J. JUNE 22, 2021

Global Clinical Trials, LLC (“GCT”) is a premier contract research organization providing clinical services in the U.S., Europe, and Asia. The company is delighted to announce the celebration of 20 years helping small and large pharma, biotech and medical device companies run their clinical studies. In the following months, GCT will be publishing media content, including the stories of GCT employees and empirical lessons that contributed most to the growth of the company and its service offerings.

Founded in 2001, GCT transitioned from a well-known local provider in Central-Eastern Europe, to a global CRO with operations in 11 countries through offices in Bulgaria, Georgia, Hungary, India, Kazakhstan, Lithuania, Poland, Romania, Russia, Ukraine, and the U.S. GCT fully supports projects in various therapeutic areas from phase I through IV, providing targeted, flexible and cost-effective solutions.

It has been a fantastic journey since we started literally from the scratch. Our team has grown both professionally and in number, and now we are able to support clinical trials globally. The driving force for all of us has always been changing needs of the customers” – shared GCT President, Dr. Jeff Apter.

During its 20 years on the market, GCT has achieved a number of milestones:

  • Increased the number of full-time employees from <5 to 100+
  • Established 11 clinical offices worldwide
  • Managed clinical trials in Bulgaria, Czech Republic, Estonia, Georgia, Germany, Hungary, India, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Romania, Russia, Slovakia, Ukraine, and the U.S.
  • Opened internal Data Management, Biostatistics and Medical Writing departments
  • Enhanced the project portfolio with 200+ clinical trials
  • Earned repeat business from the same clients

Eugene Selivra, CEO of GCT said, “GCT’s main objective has always been and remains the patients’ safety and well-being. Our business grew gradually: both by answering new opportunities and demands for particular country or service, and by relaying on the expertise and drive of local professionals pushing to add their countries to the map of clinical trials. After all, behind all our success, stand the people who are talented, passionate, and devoted professionals. Our biggest achievement is the customers’ confidence and trust in GCT. What used to be an idea is now a reality.”

About GCT

Founded in 2001 by Jeffery Apter, MD and Eugene Selivra, MD, GCT is a premium contract-research organization (“CRO”) supporting Phase I-IV clinical studies and post-marketing activities for international and local Big Pharma, small and medium-sized biotech enterprises, groups and funds, as well as large universities and institutions. GCT guarantees a tailored approach for every project and provides its clients with both standalone services as a functional service provider (FSP) and excellent full-service support during study start-up, active project phase and study close-out. GCT stays fully-compliant with the latest GCP, EMA and FDA guidelines, and local regulations. 

Migraine & Headache awareness month

Most of the adult population has experienced headache at least once in the last half a year. These headaches can range from a mild discomfort to debilitating migraines. If headache is recurrent, it classifies as a headache disorder.

We are encouraging everyone suffering from headache to seek diagnosis and treatment options. Effective migraine treatment can result in a significant improvement in the patient’s quality of life.

Myasthenia Gravis Awareness

June is Myasthenia Gravis Awareness month. Myasthenia Gravis, commonly referred to as MG, is a neuromuscular disorder that weakens the skeletal muscles responsible for movement by impairing the connection between the nerves and muscles.

Please find more information about the disease here: https://gctrials.com/posts/june-2020-myasthenia-gravis-awareness-month/

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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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