Pulmonary Fibrosis Awareness Month

September is Pulmonary Fibrosis Awareness Month. Pulmonary Fibrosis is a condition when lung tissue becomes damaged and scarred, eventually causing shortness of breath. Medications are available to mitigate the symptoms. However, the disease cannot be cured.

Please contact us at gctrials.com to find out more about GCT experience in respiratory diseases and have we can assist you in conducting a clinical trial.

Happy Birthday, Dr. Sahoo!

Wishing a very happy birthday to Dr. Umakanta Sahoo today! Umakanta is the General Director at GCT India. We feel proud and lucky to have such a talented and diligent colleague on our global team.

We are wishing you great success and plenty of wonderful moments ahead!

Lessons learned in 20 years

Recruit your staff in advance

Expansion to new regions and opening new offices bring many new challenges, including the need for rapid growth in employee numbers. The need to hire professional and dedicated staff becomes more urgent than ever.

Hiring in a hurry can result in a few misses. There is a risk of not always getting the best candidate and hiring a less-than-ideal candidate.

Strategic foresight and anticipating potential future needs help GCT executives find the right new people for the team in advance, relying on full-time employees exclusively at all our locations.

To be global you need to think local

We have been on the market for 20 years, growing every year. Each time we added a new country to our operations, we discovered that everything was a little (or a lot!) different there.

To operate successfully in the realm of a foreign legal and healthcare system requires high expertise of our local employees.

However, understanding the new social and cultural context is no less important. Business communications, meetings with clients and interactions with doctors are crucial to succeed in the field of clinical trials. So, being able to adjust to the new norms every time you step foot on the foreign soil is a necessary skill.

Employee Story: Dmytro Mnozhynskyy

Which office are you located at?

Kyiv, Ukraine.

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

It is hard to believe, in a few months I will celebrate 15th anniversaryJ. I helped the company to start operations in Ukraine and keep managing the local office since the very beginning. At the same time, the project management and everything around it takes most of my time.

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

Definitely, my expectations have been fully met. I was looking for a place with involvement in multiple and completely different tasks, with friendly surrounding, and quick decision makers. So, it is all here.

What surprised me? Probably the case with the first study initiated in Ukraine. I did not expect we would win a project for the country in just a couple of months after we had opened our operations here. We progressed very fast and delivered high-quality results, which were proven by the repeated business we received after. 

What has changed at the company since you joined?

Well, I would say everything. The company grew from year to year gaining its various and vast experiences in different fields of clinical research. It finally matured to the level we all are proud of. I like knowing that we can do full service now, from clinical, medical and regulatory aspects to logistics, quality assurance, safety and statistics, with presence and coverage in Europe, in Asia-Pacific region and in the US.

What is important for you at GCT?     

It is, of course, relationships in the team. It is extremely important to trust in people you are working side by side. We try to build not just a study team devoted to the certain project, but a family of open-minded professionals ready to brain-storm in a critical moment and keep a steady pace in a routine task.

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

It is hard for me to choose just one event. I would say every investigator meeting organized by GCT deserves to be mentioned. This is the start of the hard work under the project regardless of its duration and at the same time an opportunity to meet with the team, with investigators, with Sponsor, and with vendors. During such events we become closer to one another, which helps significantly even after returning to our offices located across different countries and continents.

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

It was the day when I accepted the offer and I never doubted the decision made.

What do you think the mission of GCT is?

We are a part of a long chain of those who develop new medications and drive human health forward. Our mission is to bring new knowledge into pharmaceutical development with the highest quality of human data and within shortest timeliness. We are fighting for patient’s safety, working today to build a safe tomorrow.

Describe GCT in 3 words

Innovative, GCT continuously explores new paths to achieve better results.

Focused, where every detail matters.

Respectful, value patients, professionals, processes.

How do you see GCT in 10 years?

It is a long way, indeed. A company addressing global challenges in the clinical research.

GCT to Manage Phase III COVID-19 Study

Global Clinical Trials is adding yet another COVID-19 clinical trial to its Infectious Disease portfolio. As a part of a multi-national project, GCT will manage the double-blind Phase III study in adult patients with COVID-19 in Russia. After a thorough feasibility analysis, GCT clinical team together with the Sponsor selected the clinical sites with the most enrollment potential.

As the COVID-19 pandemic is still ongoing and the mortality is considerable, the global population is in need of new treatment options to mitigate the virus. The safety and efficacy of the investigated drug has previously been confirmed during the phase II trial. The phase III study aims to further support the product efficacy claims.

The project is currently in the active start-up phase, with regulatory submissions ongoing. All site selection visits have successfully been performed by the GCT clinical team. “Doing our part in helping fight the consequences of the virus is extremely important to us and is the mission of GCT. We are thrilled to be working on another project with our long-term partner,” – said Dr. Jeffrey Apter, GCT President.

Meet GCT at World Orphan Drug Congress USA 2021

GCT CEO, Dr. Eugene Selivra and Senior Director of Business Development, Natalia Katsnelson

Meet GCT CEO, Dr. Eugene Selivra and Senior Director of Business Development, Natalia Katsnelson at World Orphan Drug Congress USA. The event is taking place today, August 26 and tomorrow, August 27 at Gaylord National Resort & Convention Center, Oxon Hill, Maryland .

Reach out to us at bd@gctrials.com to schedule a meeting.

Happy Birthday, Alina!

Today we are celebrating the birthday of Alina Mitrofanenko, a GCT Project Manager. Alina has been with the company for over 10 years now bringing an unparalleled level of expertise and diligence to the team. Alina truly is an exemplary colleague and a delightful person to be around!

Dear Alina, we thank you for being a part of our global team and wish you a magnificent year ahead!

Psoriasis Awareness Month

August marks Psoriasis Awareness Month.

Psoriasis is a multisystem condition, in which skin cells build up and form scales and itchy, dry patches, causing the patient a mild discomfort or sometimes affecting the quality of life seriously. Those who suffer from psoriasis are often forced to make activity and clothing choices influenced by the condition.

It is a chronic autoimmune disease which cannot be healed. However, there are many treatment options available to mitigate the condition.

Millions of patients worldwide will benefit from spreading information about psoriasis. Despite the common myths around psoriasis, it is neither contagious, nor infectious.

Happy Birthday, Sergiy Nayda!

Yesterday Sergiy Nayda, Senior Clinical Research Associate at GCT, celebrated his birthday.

Sergiy has been an inevitable part of our team for over 13 years now, managing diverse projects in Ukraine and doing excellent work.

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

GCT at CPhI North America

CPhI North America is taking place from August 10-12, 2021 at the Pennsylvania Convention Center in Philadelphia.

Represented by Natalia Katsnelson and Elizaveta Medvedeva, GCT team is participating at the conference and reconnecting with industry peers both online and in-person.

Reach out to us at bd@gctrials.com to book a meeting.

August is Children’s Eye Health and Safety Month

Good vision and eye health are especially important for children’s development.

The start of school also means the start of autumn sports and other activities that can lead to eye injuries. 42,000 Americans suffer sports-related eye injuries every year, with children accounting for the majority of these cases.

What can you do to prevent this?

  • All children should wear the recommended protective eyewear during sports or outdoor activities
  • Children should only have access to age-appropriate toys and avoid toys with sharp or protruding parts
  • Keep cleaning products and sprays out of the reach of children.
  • Teach proper handling of toys such as darts, bows, arrows, and air/biological weapons, or discard them altogether

GCT also encourages including a comprehensive eye examination as part of your child’s preparation for school.

A pediatric optometrist can identify common refractive abnormalities:

  • Myopia
  • Farsightedness
  • Astigmatism
  • Amblyopia (lazy eye)
  • Strabismus (crossed eyes)
  • Ptosis (drooping eyelids)
  • Color deficiency (color blindness)

Meet GCT at the World Orphan Drug Congress USA

August 26th-27th, 2021, GCT CEO, Dr. Eugene Selivra, and Senior Director of BD, Natalia Katsnelson are participating at #WODCUSA in Oxon Hill, MD.

We are excited to be back to in-person conferences this month! We are looking forward to sharing our experience in conducting #raredisease clinical trials globally in today’s environment and to meet industry peers.  

The 11th annual World Orphan Drug Congress USA is planned to be held in person to meet, brainstorm, and discuss the ways to advance the development of orphan drugs and improve access to life-saving treatments.

To schedule a meeting, please contact us at bd@gctrials.com or directly through the conference platform https://app.swapcard.com/event/world-orphan-drug-congress-usa-2021-1/person/RXZlbnRQZW9wbGVfNzg0Njg0Ng%3D%3D

We look forward to seeing you there!

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.

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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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