News archive
2011
April news
New project in Russia and US
Global Clinical Trials is pleased to announce that we have been awarded a trial recruiting patients suffering from Wegner's Granulomatosis. This challenging trial will involve experienced sites in Russia and the United States. "Performing services in the US is not typical for us; however it demonstrates our flexibility to address the needs of our clients in providing them a trusted partner willing to find solutions" said Chief Executive Officer, Dr. Eugene Selivra. The investigators meeting is scheduled for June.
Welcome!

Antonina Nabokova
April 2011; St. Petersburg, Russia
March news
Regulatory approvals

Ministry of Health building in Moscow
GCT obtained regulatory approval for Phase II study in hematology to be conducted in Russia.
Device study enrollment progress
GCT reached 50% enrollment milestone in a device study in ophthalmology being conducted in Russia. The study is performed for one of the largest ophthalmology companies in Europe.*
March 2011; St. Petersburg, Russia
Steady recruitment

Histopathogic image of senile plaques seen in the cerebral cortex in a patient with presenile onset of Alzheimer disease.
GCT reached an interim recruitment goal of 50% of the targeted number of patients in a phase II study in Alzheimer's disease.
February 2011; St. Petersburg, Russia
Alzheimer's programs
Enrollment complete

St. Petersburg Geriatric Care Center, one of the major enrollers for our Alzheimer's projects.
Global Clinical Trials successfully completed the enrollment of a 200 patients Alzheimer trial in Ukraine and Russia. This Phase 2 trial was the first in the series of trials in Alzheimer's disease GCT is conducting for a top 10 Pharmaceutical Company.
Doubling the sites
GCT was recently asked to double the number of sites in Russia on another ongoing international Alzheimer's trial to help supplement global enrollment. In discussion, Dr. Eugene Selivra, CEO said, " this increase in sites reflects well on the value of performing Alzheimer's studies in Russia; the professionalism of our experienced investigators and the expertise of our operational team. This request benefits our CNS franchise as a whole as we look forward to continuing our growth in this challenging therapeutic area." The Investigator's meeting for the additional sites will be held in St. Petersburg, Russia during the 2nd week of February.
January 2011; St. Petersburg, Russia
2010
December news
New Ophthalmology program

A comparison of a normal eye (left) and an eye with glaucoma showing the large cup area in the middle of the optic nerve.
We are pleased to announce the awarding of another Ophthalmology trial. This award highlights our customer service focus and expertise in the therapeutic area as it is the 3rd such trial we will be performing with this Sponsor. The trial is in Glaucoma and will be performed at 6 sites in Russia.
IWW Award
General Director of our Bulgarian office, Dr. Mitko Shoshev has been selected to be a member of the Who's Who International Historical Society. We congratulate Dr. Shoshev on his accomplishments.
December 2010; St. Petersburg, Russia
November news
Ophthalmology project

St. Petersburg Eye Miocrosurgery complex, one of the major enrollers for our ophthalmology projects.
Industry meetings

Dr. Zhuravlev making his presentation at the plenary session of OCTER conference.
Alzheimer's Disease study in Bulgaria
The database for an Alzheimer's Disease study in Bulgaria for a Top 20 pharmaceutical company was closed this month. This was a part of multinational global study where GCT recruited the targeted number of patients 1 month ahead of schedule. We would like to thank all investigators in Bulgaria who participated in this clinical study with GCT for helping us to achieve these aggressive timelines.
November 2010; Princeton, NJ, USA
Psoriasis program

A microscopy image of skin in psoriasis.
We are preparing for a new phase III trial in Psoriasis to be conducted in dermatology sites across Russia.
This project is a part of multinational clinical study conducted by one of the biggest pharmaceutical company in Europe.
GCT will be responsible for enrolling 350 patients in Russia. The enrolment is scheduled to be launched in February 2011.
October 2010; St. Petersburg, Russia
New study in Alzheimer's

Two transaxial MRI slices through the head. The right image shows a normal brain; the left has differences that are interpreted as indication of Alzheimer's disease.
Global Clinical Trials is pleased to announce the award of another multi-country Alzheimer's trial, further establishing our CNS expertise in the region.
This Phase II trial which is to be performed in Bulgaria and Ukraine will study mild to moderate Alzheimer patients.
This marks our 4th Alzheimer's project from this Top 20 Pharmaceutical company which is illustrative of the quality of services we are proud to deliver.
September 2010; Princeton, NJ, USA
New projects, team expansion

Alexandra Zaichenko in her new office
GCT was awarded an ophthalmology trial in dry eye syndrome which will randomize fifty patients in Russia. The trial is scheduled to be launched in early October, 2010.
GCT was awarded a phase II trial in Hematology to be conducted in 5 sites across Russia. The project is planned to be submitted to the regulatory authorities during the 1st week of September, 2010.
GCT is proud to highlight another addition to the GCT team. Alexandra Zaichenko, M.Sc., joined GCT as Director of Business Development. Alexandra comes to GCT with 6 years of experience in the Pharmaceutical industry serving both Pharma and Biotech Clients. Prior to GCT she was in responsible for global business development for medium sized international CRO in Russia.
August 2010; St. Petersburg, Russia
July news
Global Clinical Trials recently completed enrollment of 185 patients for an ongoing Glaucoma trial one month ahead of schedule. In meeting the needs of the client, GCT leveraged their relationships with the sites to maximize their individual patient data bases and exceed the enrollment goals of the trial. The project is now well positioned to complete early and stay ahead of their development schedule.
GCT was selected to perform regulatory services and clinical support for an international project requiring 5 sites in the Russian Federation. This multi-national phase III trial in Alzheimer's Disease is scheduled to begin recruitment this Fall.
July 2010; St. Petersburg, Russia
DIA in Washington

Plenary session
At the recent 46th DIA in Washington, D.C., Global Clinical Trials was more than just another exhibitor. Vice President Richard Leach was selected by DIA to chair a session titled: "Risks and Benefits in Utilization of the Regional Service Providers (RSP) Model when Conducting Global Programs".
Through the use of case studies and the interaction of experts from both CROs and Sponsors, they presented the attendees with a balanced perspective on the real challenges and benefits of this Global model.
When asked about the potential value in performing trials using the RSP model Mr. Leach explained, "Clinical Research Today is a global endeavor requiring expertise in study management and coordination in countries throughout the world. To address this growing need many sponsors have elected to work with large global CROs with global offices and incredible infrastructure driving their rates higher without necessarily adding value to the project. Think of the benefits of paying local rates to experienced regional service providers who have the specific expertise of managing your trial across a few countries where enrollment is at a premium. The potential in savings can be quite serious".
If you would like to receive a copy of the presentation please e-mail rl@gctrials.com and a PDF version will be forwarded.
June 2010; Princeton, NJ, USA
Ophthalmology trial enrollment
Global Clinical Trials would like to congratulate Ophthalmology sites in our current glaucoma trial. The study which was planned for 6 months enrollment has already met 50% of it's enrollment goal of 180 patients after only one month.
We look forward seeing our Investigators at the upcoming 16th International Ophthalmology Congress "The White Nights", which will take place in Saint Petersburg, Russia, May 31st through the 4th of June. GCT is a proud sponsor and informational partner of the Congress for the last 3 years.
April, 2010; St. Petersburg, Russia
EPC Publication
GCT is proud to announce that Dr. Adrian Iancu, General Director of our Romanian Office, has placed an article (PDF) in the current March Edition of EPC Journal (European Pharmaceutical Contractor). In this article Dr. Iancu researches the many benefits associated with performing clinical trials in Romania. Dr. Iancu has been with GCT since 2007 having accumulated more than 11 years experience performing clinical research in Romania.
March, 2010; Bucharest, Romania
Investigator Meeting

CRF completion training
GCT has set up and managed an Investigator Meeting in St. Petersburg for a 180 patients phase III Glaucoma project.
An important milestone in the study, the event has been visited by Russia's top opinion leaders in Glaucoma, which allowed direct contact between the Sponsor, Investigators and GCT teams facilitating open dialog and productive cooperation.
February, 2010; St. Petersburg, Russia
2009
First patients in Alzheimers' program

Microscopy image of a neurofibrillary tangle, conformed by hyperphosphorylated tau protein
Global Clinical Trials is proud to announce the first enrolled patients for an International Alzheimers' program. This program, from one of the largest pharmaceutical companies in the world, is planned to enroll more than 300 patients at 27 different sites across Russia, Ukraine and Bulgaria.
The CEO of Global Clinical Trials, Dr. Eugene Selivra, expressed strong support for the project team. "This project team was tasked with starting up a challenging international project within a very narrow window to get the first patient enrolled by the end of the year. The teams customer focus, regulatory expertise and attention to detail made this possible and I congratulate the team in their achievement."
December, 2009; Moscow, Russia
BizAcumen publication and upcoming DIA meeting
Global Clinical Trials, LLC was featured recently in the BizAcumen Report on Contract Research and Outsourcing. The article highlights our growth over the last few years, providing detailed insight into our success. It demonstrates our position as one of the most experienced and customer focused CROs, capturing our regional focus and multi-therapeutic capabilities.
See more information about this report or request your copy.
In other news, our Vice President of Business Development, Richard Leach, has been selected to chair a session at the upcoming United States DIA held in Washington this coming June. The session that Mr. Leach has been asked to chair will highlight the value of regional CROs in performing global projects.
He will be joined by several other speakers from both Pharmaceutical and Biotech organizations that have experience with the Regional Service Provider (RSP) model. Mr. Leach will provide his own insights on the usage of the model, as learned from his own successful implementation. It is widely accepted that working with regional CROs will save you both time and money over the "overhead intensive" and more expensive Global CROs. The challenge, however, is the management of the process and the construction of a unified team working together across country/company lines. This session will discuss the many ways our speakers have addressed these challenges and were able to complete their projects on time and under budget, sharing their various stories of success and tribulation.
November, 2009; Princeton, NJ, USA
Women's health program

Moscow city hospital #31, one of the major enrollers in our programs
In the month of October GCT has accomplished the selection of 20 sites in Russia for an extensive women's health program for a US-based Pharmaceutical Company.
This milestone marks five years with this Company being our oldest Sponsor, with more than fifteen hundred patients enrolled in various studies.
We are looking forward to continue this collaboration, which has already greatly contributed to the mutual success of both Companies.October, 2009; Princeton, NJ, USA
Expansion to South America

Aerial view of Buenos Aires, the capital of Argentina.
Global Clinical Trials is pleased to announce our expansion into Argentina, South America.
Argentina has been one of the fastest growing countries in the region for clinical research. In 2008 Argentina harmonized its clinical trial regulatory requirements to conform with international best practices making the country more desirable for clinical research and bringing it in line with global programs.
“Our clients help provide direction on where we need to be.” Said Dr. Jeffrey Apter, President of GCT. “Based on client feedback and requests they help to identify the countries with the best the enrollment opportunities and Argentina fits that bill. The sites are experienced and the patients are motivated to participate creating an excellent environment for clinical research.”
Argentina provides our clients a location in the Southern Hemisphere where they can be confident in the professionalism and experience of the sites.
September, 2009; Princeton, NJ, USA
Glaucoma project

MRI of a human eye
GCT proudly announces the award of a multi center phase III Glaucoma project.
This project marks the 2nd Ophthalmology project from this client; the first successful trial was performed in the Ukraine. We are excited to be working once again with this client, their belief in our capabilities to get the job done reflects well on our quality and our commitment to our clients.
The project continues to expand our growing experience in Ophthalmology making GCT one of the most experienced CROs in the region in this therapeutic area. The trial, which will run entirely in Russia, will enroll 180 patients across 7 sites.
August, 2009; St. Petersburg, Russia
International Alzheimer's program

PET scan of the brain of a person with mild AD (right) compared to a healthy person (left)
During the Month of June Global Clinical Trials initiated work for one of the top Pharmaceutical Companies in the world, to support their global Alzheimer's program in Russia, Ukraine and Bulgaria. In all, 26 sites across these three countries were selected to take part in this phase II global program. Dr. Eugene Selivra, CEO of GCT, is excited by the opportunity to work with such a large and dynamic organization. "Though we have worked with other similar organizations this opportunity helps demonstrate our growth as a company, having been selected to manage such a significant piece of a global project. We feel very comfortable in being able to meet the needs of the sponsor and developing a long term relationship that will benefit both organizations," said Dr. Selivra.
June, 2009; Princeton, NJ, USA
Enrollment completion

One of the major hospitals participating in the program, St. Petersburg, Russia
Global Clinical Trials announces the completion of enrollment for two large women's health projects. During the month of May we have successfully completed enrollment of two studies in Mixed Bacterial Vaginosis / Vulvovaginal Candidiasis Infections. The first trial required 29 sites to enroll 393 patients and the second trial required 20 sites to enroll 209 patients. GCT will continue to monitor both projects through to their successful completion this summer.
May, 2009; Moscow, Russia
Industry meetings

Our booth section at EuroDIA, Berlin
The month of April concluded with GCT attending the 18th Annual Partnerships Meeting in Orlando, Florida. GCT shared a booth with our US partner, ResearchPoint Global, promoting our shared capabilities to provide global trial support. During the end of March we have attended and exhibited at the 21st Annual European DIA meeting in Berlin, Germany.
The meetings gave us the opportunity to promote our services to both current and potential clients and catch up on Industry trends and changes. Both meetings proved to be successful and well attended. Our next meeting will be at the end of May for the ASCO meeting in Orlando, Florida. If you would like to meet with us at any meeting please submit your request. We look forward to seeing both old and new clients at ASCO.
April, 2009; St. Petersburg, Russia
Oncology program completion

Histopathology of breast carcinoma.
Global Clinical Trials, LLC successfully accomplished an International Multicentre Phase II trial studying the primary systemic therapy for women with operable breast cancer.
This was 3 year project, a part of a European Cooperative involving more than 12 other countries globally to measure the current success of treatment.
March, 2009; St. Petersburg, Russia
New project in Russia

Histopathology of breast carcinoma.
February, 2009; Moscow, Russia
Oncology study in Ukraine

Histopathology of breast carcinoma.
January, 2009; Kiev, Ukraine
2008
FDA audit

FDA CDER building in Silver Spring, Maryland, USA
December, 2008; St. Petersburg, Russia
Global Clinical Trials makes management changes

Kirill Zhuravlev, M. D., Ph. D.
and Elena Patokina, M. Sc.
Elena Patokina, M. Sc. the former General Director of Russian Operations, has been promoted to Director of Strategic Development. In this role Ms. Patokina will be responsible for interaction with key clients as well as developing strategies to improve our internal processes and work to continually improve the GCT product globally. Both Dr. Zhuravlev and Ms. Patokina will be based in the GCT St. Petersburg office. We wish both Dr. Zhuravlev and Ms. Patokina much success in their new roles.
November, 2008; St. Petersburg, Russia
GCT expands Drug Storage and Central Pharmacy capabilities

Climate controlled storage area.
GCT in creating a unique CRO model developed a stand alone logistics group that works across studies and is responsible for all importation/exportation activities within the Russian Federation. GCT logistics maintains a coordinated team of experienced professionals familiar with the regulations and process of logistics in Russia. Offering a broad and successful interaction with the regulatory authorities since 2001; GCT has established partnerships with international and local courier services, and has developed effective and proven logistics schemes designed to expedite the process.
The newly expanded facility provides a total area of 356 square meters of storage space, more than tripling the previous space available. Within the facility is a walk in refrigerated storage unit
”Our new expanded capabilities provide us the opportunity to continue to service our growing client base while expanding available services within our organization“, Said Dr. Eugene Selivra, CEO. ”We are a customer focused company, and this expansion reflects our commitment to continue to meet the needs of our clients“.
October, 2008; St. Petersburg, Russia
Investigator Meetings in September
During the month of September Global Clinical Trials set up and managed three Investigator meetings. First meeting for 50 clinical sites involved in womens health program in Russia was conducted in St. Petersburg. It was followed by 12 site oncology trial meeting in Kiev, Ukraine. At the end of the month another meeting for gastroenterology project was conducted in St. Petersburg for 46 clinical sites from both Russia and Ukraine. Currently GCT is initiating enrollment in all three projects.
September, 2008; St. Petersburg, Russia
Enrollment completed ahead of schedule
Global Clinical Trials completes enrollment ahead of schedule for a women's health program. On July 24th the GCT announced enrollment complete ahead of schedule for Endometrioses Phase II project. Congratulations to the study team for demonstrating the value Global Clinical Trials can bring to our clients and the professionalism we share with the sites.
July, 2008; St. Petersburg, Russia
Regulatory Approvals and Enrollment Initiation
GCT received regulatory approval for a 50 center 660 patient trial studying patients suffering from mixed bacterial vaginosis and vulvovaginal candidiasis infections. This program represents 2 studies to be run simultaneously exclusively in the Russian Federation further expanding our already significant women's health experience.
During the month of June GCT also received approval from both the Russian and the Ukrainian Ministry of Health to perform a 46 center, 316 patient trial in a moderately active ulcerative colitis project. This project will be spread between 31 sites in Russia and 15 sites in the Ukraine continuing to solidify GCT's regional expertise in gastroenterology.
GCT is pleased to report that during the last week of June, the first 5 patients were enrolled in a 5 center, 50 patient trial studying the effects of our Sponsor's study medication in women with moderate to severe pain associated with endometriosis.
June, 2008; St. Petersburg, Russia
International ulcerative colitis trial

Histopathological image of the active stage of ulcerative colitis. Endoscopic biopsy.
March, 2008; Princeton, NJ, USA
New study
Global Clinical Trials is pleased to announce the award of a new study to be performed in Russia for Endometriosis. This phase II trial will be performed at 5 sites with the focus to enroll 30 qualified patients within a 3 month period and follow each patient for 4 months. GCTs part in this project is as part of a global program being performed by a US based pharmaceutical company in numerous countries throughout the world. "We are excited to be participating in this challenging program", said Dr. Jeffrey Apter, President of GCT. "This allows us the opportunity to expand on our growing experience in Womens health while fulfilling the needs of one of our most valued clients. This will be the third study we will be performing for this organization and we are committed to their success".
January, 2008; St. Petersburg, Russia
Enrollment completion
We have successfully completed the enrollment of a large Russian Gastrointestinal program. This program, being performed on behalf of a US based Pharmaceutical Company, involves 15 sites who have recruited 402 patients in a 8 month period. This program marks the third such program in this indication for GCT in Russia providing continued experience across this growing therapeutic area.
As recruitment continues to challenge the Clinical Research community in both the US and Europe more trials of this nature are being introduced in Russia and Eastern Europe. Enrollment in this region of the world tends to be 3 to 4 times that of Western Countries, depending on therapeutic area. Even the most challenging of programs have benefited from working in this region of the world, adding critical patient data to difficult and sluggish programs. The clinical experience and motivation of the sites combined with an educated and compliant patient population makes this region the most highly regarded area in the world for quality clinical data.
The experience gained from with program is critical for the continued growth and success of Global Clinical Trials. “The ability to perform trials of this size involving detailed imaging, using local laboratories in sites across Russia is crucial for our clients success”. Said Elena Patokina, General Director of the St. Petersburg office. “We have a practiced and experienced team working on this project which have developed strong relationships with the sites. Their leadership and communication skills helped in facilitating enrollment, meeting all protocol requirements while maintaining Good Clinical Practices.”
This project will continue for another 6 months, however having met the enrollment goals of the client GCT is confident the project will complete on schedule.
November, 2007; St. Petersburg, Russia
2007
GCT opens new office in Bucharest, Romania
We are proud to announce another service expansion with a new office in Bucharest, Romania. This new office will be responsible for managing clinical, logistical and regulatory activities in that country to support GCT's growing list of clients. Running the office for GCT in Bucharest is Adrian Iancu, MD, MBA. After years of working within the Romanian Ministry of Health, Dr. Iancu completed his MBA at the University of Pittsburgh and joined Wellcome, East Europe, Ltd as Medical and Regulatory Adviser. Following the merger of Wellcome and Glaxo Dr. Iancu joined Novo Nordisk A/S local office in Romania as Medical Adviser. As Medical Advisor he was directed to create and manage a new office responsible for clinical development and regulatory interactions; in addition to medical-marketing activities. For 10 years Dr. Iancu continued to grow Novo Nordisk's office while being responsible for performing multiple clinical trials and maintaining daily interaction with the Ministry of Health. After receiving numerous accolades and several promotions from the Novo Nordisk management team, Dr. Iancu left to pursue additional business opportunities outside of clinical development. In his role as General Director of the office GCT will rely on his scientific and clinical expertise as well as his in-depth knowledge of the Romanian regulatory process and his well developed entrepreneurial skills.
"Romania continues to be a growing clinical research presence in Eastern Europe," said Dr. Eugene Selivra, CEO of Global Clinical Trials. With a population of 22 million people, Romania is the 3rd most populated Eastern European country (behind Ukraine, and Poland). Since 2004 applications for clinical research (phase I through IV) have increased by 65%. "This opens up additional capabilities for our clients that are interested in taking advantage of the strong enrollment potential of Eastern Europe while still meeting all requirements of the European Union. The Romanian National Medicine Agency is fully harmonized with the latest EU directives and for some of our clients that is an important aspect of working in Romania" said Dr. Selivra. When asked about the future growth of GCT Dr. Selivra was very open in saying, "wherever our clients want us to be, we will be there".
4 October 2007
GCT sponsors Investigator Meeting and initiates enrollment for a new project in Ukraine
GCT completed another successful Investigator Meeting in Kiev, Ukraine for an ophthalmology product. The local office of GCT, Ukrainian Clinical Trials (UCT), was responsible for the administration, presentation and overall performance of the investigator meeting. With support from the Russian office, UCT put together a complete program which covered the protocol as well as CRF completion, monitoring practices, and GCP review. The Sponsor was given the opportunity to discuss the study drug, previous trial history and highlighted specific areas of the protocol to ensure compliance and patient care. There was an excellent exchange of ideas and the attendees all left fully understanding the study compound and the design of the study. In all the meeting was a complete success, the attendees had an excellent opportunity to meet with each other both during the meeting and afterwards in a relaxed and comfortable environment to exchange ideas and promote relationships. Enrollment in the study was initiated the very next day following the meeting at multiple sites.
22 September 2007
Enrollment milestone
GCT is proud to announce that we have reached exactly 50% enrollment in a large Phase III program designed to treat peptic ulcers. "We are excited to reach this milestone for this Russian only Phase III program" stated General Director, Elena Patokina. "We are ahead of schedule in recruiting 402 patients and actually expect to see enrollment increase even more following the summer months."
Typically clients come to Russia with very difficult patent populations to recruit, or complex projects that allow for only a small percentage of available patients to participate. This trial shows the real value that Russia and Eastern Europe can bring to a clinical program requiring patients that meet a fairly standard enrollment criteria. When sites in other countries are recruiting 3 to 5 patients per month Russian sites will typically out perform them by two or three times allowing for a more rapid study completion and an expedited submission to the authorities.
16 July 2007
Ophthalmology experience continues to expand at Global Clinical Trials
Global Clinical Trials, LLC (GCT) parent organization of RCT Global is pleased to announce the continuation growth in our Ophthalmology franchise. Currently GCT is providing Ophthalmology research services in Russia, Ukraine, Bulgaria, Poland, the Czech Republic and Romania. Having just submitted the regulatory application for a 5 site 150 patient Glaucoma trial in the Ukraine makes a total of 5 ongoing ophthalmology programs at different stages of completion. «We recently completed enrollment for one large Russian program in Diabetic Macular Edema involving 192 patients at 14 sites, while initiating enrollment on a study for Age Related Macular Degeneration for more than 100 patients at 10 sites», said CEO of GCT, Dr. Eugene Selivra. «We have very quickly become the most experienced CRO in the region in this challenging therapeutic area. Over the last two years we have learned a great deal about where to run these trials and the key success factors associated with completing the projects on time. As a result we have developed a specialized team to address this therapeutic area and bring our current and relevant experience to the table». Dr. Selivra sees the future of Ophthalmic research in Russia as very promising and believes «we are only touching the surface of the real potential in this region».
Considering the growth of other therapeutic areas across the region it is not a stretch to see strong growth in this therapeutic area. Both Oncology and Cardiovascular trials have grown ten fold over the last few years. CNS indications like Alzheimers and Depression have also grown significantly in this region over the last few years creating a very experienced and professional investigator network. Should Ophthalmology trials follow a similar pattern Global Clinical Trials is well positioned to benefit from the growth and bring their own experience and dedication to customer satisfaction to clients from around the world.
23 June 2007
Meetings in St. Petersburg
Global Clinical Trials office in St. Petersburg (RCT Global) sponsored two major events in the St. Petersburg Hotel, St. Petersburg, Russia the 15th World Congress of the World Association for Dynamic Psychiatry, May 14-18, and the 13th International Ophthalmology Congress, May 21-24. The rich programme of the congresses attracted hundreds of opinion leaders in corresponding fields from all over Russia, former Soviet Republics and many countries of the Western Europe. The representatives of the company hosted a booth at both meetings providing corporate literature and discussing our services to the many of the attendees.
These meetings gave us the opportunity to meet with many of the current clients and investigators we have worked with over the last few years and thank them for there business and professionalism. In addition to those we have already worked with we were able to make many more contacts with ophthalmology and psychiatry/psychoneurology professionals to add to our investigator database and potential client list. The meeting proved to be a huge success offering excellent educational seminars and many opportunities for side discussions and meetings to facilitate closer client relationships and strong investigator interaction.
16 May 2007
RCT Global attends Industry Meetings
RCT Global participated in two industry meetings during the month of April. Early in the month RCT Global exhibited and spoke at the European DIA conference held in Vienna, Austria. This meeting, which is one of the largest European meetings for our Industry, offered a strong concentration of Regulatory sessions as well as Data Management, Electronic Data Capture and Project Management sessions. Mr. Richard Leach, Vice President of Business Development for RCT Global was invited to speak as part of the Project Management track comparing the challenges and benefits associated with working with large global CROs Vs smaller more focused Regional Service Providers. The session was well attended and provoked good discussion and attendee feedback. The Euro DIA exhibit hall represented companies from around the world with a strong concentration on European service providers. In general the meeting was a great success encouraging interaction between both current and future clients as well as other service providers.
In addition to Euro DIA RCT Global also attended and exhibited at the United States Partnerships meeting in Orlando, Florida. The meeting, which focuses exclusively on the challenges of outsourcing in pharmaceutical development, was very well attended. The Grand Opening of the exhibit hall included special guest, Bob Eubanks from the US Television show “Newlyweds Game”. He spoke about some of his most memorable couples, viewed TV clips and actually interacted with the group in a special fun presentation of “The Partnerships Game”. The exhibit hall represented service providers from around the world offering services across all phases of research. The meeting gave RCT Global the opportunity to again meet with both current and future clients and allowed us to interact closely with our partners involved in the ResearchPoint Global Network.
Have a look at the presentation from DIA
23 April 2007
Opening in Ukraine
We are proud to announce the opening of our new operational office in Ukraine. «RCT Global has been operating in the Ukraine for a few years, however due to our growth and the needs of our clients this is a very important and natural expansion», said Dr. Eugene Selivra, Chief Executive Officer, Global Clinical Trials (Parent Company of RCT Global). «This allows us the opportunity to work in the Ukraine and handle all aspects of the clinical trial from a centralized office with experienced monitors and project managers». The office in the Ukraine will work under the name UCT Global, is located in Kiev, the capital of the Ukraine and its most populated city.
Heading up the office is Dr. Dmytro Mnozhynskyy. He is responsible for the administrative functions and project management of the office, including human resources, facilities, purchasing, feasibility, communication with regulatory authorities, and regional management. Prior to joining UCT Global, Dr. Mnozhynskyy served at PAREXEL where he led a team of Clinical Research Associates in a massive international program as the Clinical Lead. Earlier in his career, Dr. Mnozhynskyy worked in Deutsche Homöopathie-Union and Health Research Services as a Clinical Research Associate and Clinical Research Coordinator in Ukraine and Germany. In addition to his experience in conducting clinical trials Dmytro Mnozhynskyy also has practical experience in medicine as a Urologist. Prior to entering the clinical research field, Dr. Mnozhynskyy was staff Urologist at the Department of Kidney Transplantology and Dialysis, Institute of Surgery and Transplantology, Medical Academy of Science, Kyiv, Ukraine.
Check the offices section for contact information
16 March 2007
AMD Investigator Meeting
RCT Global recently hosted and completed an investigator meeting in St. Petersburg, Russia for an innovative product to address Age Related Macular Degeneration. AMD is the most frequent cause of blindness and visual impairment in the developed world generating interest among a number of companies to develop novel methods of treatment. This trial will be performed in male or female patients age of 50 years or greater with a diagnosis of subfoveal choroidal neovascularization secondary to AMD Investigator Meeting and a visual acuity: BCVA in the study eye between 20/40 and 20/320 and better than or equal to 20/800 in the fellow eye. The patients will be assessed for both ocular and non-ocular adverse events and have routine blood draws performed to monitor for systemic toxicities. The study is to be conducted in the US, Mexico and Russia. In total about 20 sites will be initiated, of which 8 will be in Russia (St.Petersburg, Moscow, Cheboksari, Rostov-on-Don). These institutions are the leading eye care clinics in the country, with highly professional ophthalmologists and a history of excellent enrolling potential.
During the meeting the investigators expressed a deep interest in participating in this program due to the novel treatment and basic delivery technique. Their active discussion of the protocol and the interaction between the sponsor organization and the sites added significant value to the meeting. At the moment there is no legally approved alternative treatment for this indication in Russia (except of laser photo coagulation). This creates an excellent opportunity for participating Russian patients to hopefully look for a cure or at least stabilization of their visual acuity. If the results of the current study confirm the efficacy and the safety of the drug with the dosage and the regimen of administration being under investigation, another more expanded study will be initiated to support product registration in the US and Europe.
19 February 2007
Russian opportunities
RCT Global has been recognized by two international publications recently requesting articles and interviews regarding the growth and opportunities found in Russia and Eastern Europe. International Clinical Trials, Winter Edition has published an article by Richard Leach, VP of Business Development for RCT Global titled “A Home for Trials, the Block Reborn”. This article highlights the current clinical research opportunities that can be found in Eastern Europe and Russia, with a break down of the first six months of 2006 of approved trials in Russia. The article identifies the great potential that is still untapped in this region of the world as it breaks down the number of trials and patients participating in clinical research by therapeutic area.
Another well respected industry publication, Centerwatch interviewed Mr. Leach specifically about the changes in Russia over the last few years and how this impacts the research process. The article, due out in March of 2007, will explore the changes that Russia has made over recent years creating an environment for success in clinical research. From developing a consistent and responsible submission process to creating a more transparent and user friendly importation service, Russia has separated itself from other emerging markets. “In the past it may have been difficult to determine starting times due to delays in regulatory approval or logistics, now we have the confidence to give our clients hard dates for study/site initiation and we typically meet or exceed those expectations” Says Mr. Leach. “The ability to develop reasonable timelines that can be consistently achieved allows sponsors to plan more effectively for the long term development of a compound.” This kind of consistency combined with the quality of the data, the increased enrollment potential and the reduced cost of services makes this region the most desired location for clinical research in the world.
Find more in press section
21 January 2007
Client meeting
RCT Global welcomed a key client this past month to perform a project kick off meeting and jointly initiate the first few sites in their Russian centric Clinical Trial. This trial represents repeat business with this US based Pharmaceutical Company; reflecting our commitment to customer service and total satisfaction. This Gastrointestinal trial will evaluate the reduction of stomach lesions using the study drug verse a current marketed product. Currently the project is planned to enroll over 400 Patients at 15 sites in a 6 month enrollment period.
The opportunity to have the client meet directly with the sites and discuss the study objectives is something RCT encourages. "The more interaction you can have between the client and the sites early on in a trial benefits both parties", said Elena Patokina, General Director of RCT Global. "We believe that communication is essential for success in business and research is no different. If a client of ours is willing to invest in the time to meet with the sites individually we will do what ever it takes to facilitate the interaction." In addition to developing stronger relationships with the sites, the Sponsor's visit also allowed the clinical team to get to know their key counterpart and begin to develop relationships that will help drive trial success.
17 february 2006
2006
Ophthalmic research
We are proud to announce that RCT Global is continuing to develop it's expertise in ophthalmic research, having been contracted to run another trial in this challenging indication.
The new trial, for Age Related Macular Degeneration, is planned to enroll up to 105 patients at 10 sites over a 4 month enrollment period. Our client chose RCT Global due to our experience in the indication and reputation within the industry. We now look forward to submission followed by a local investigator meeting early in the New Year.
21 november 2006
Logistics group
RCT Global is pleased to announce an addition to our team and an expansion of our services. Expanding on our logistical capabilities RCT Global has added the following individuals in support of our logistical and storage services:
- Nikolai Truzhenikov, Logistics Director brings over 10 years of experience handling logistics/import/export services for clinical research in Russia.
- Aleksander Zhelamsky, Customs Coordinator has worked with Nikolai over the last few years having hands on interaction with Customs and other import/export agencies.
- Anastasia Khrestukhina, Logistics Coordinator; also has worked with Nikolai over the las few years, has years of experience working with independent shipping agencies as well as government offices.
All three new employees have been working as a team for years and bring to RCT Global proven experience in logistical services across therapeutic areas. In addition to their efforts in support of our clinical research services, they also provide RCT Global the opportunity to expand their services into other industries as well. Elena Patokina, General Director of RCT Global in St. Petersburg, believes this to be a significant service advantage. “The addition of this team to our core services allows us to expand on our services, but more importantly provide experienced and practiced logistical services for our current clients that will save our clients time and allow for a quicker and more efficient study start up”.
November 2006
Investigator Meeting in St. Petersburg
RCT Global hosted a Novartis sponsored Investigator Meeting in St. Petersburg for a recently approved Breast Cancer Trial that will be running in multiple cities throughout Russia.
We are supporting all activities in Russia for this trial which is also being performed in several Eastern European countries as well. RCT Global set up and managed the Investigator meeting as well as provided presentation preparation and speaker support. Discussion was held in both Russian and English as the topics presented covered trial specific activities to include: Enrollment criteria, monitoring guidelines, logistics, laboratory preparation and reporting, SAE reporting and data capture through an electronic CRF system. The one and a half day meeting gave all team members an opportunity to meet and discuss the trial while providing for a relaxing and enjoyable evening at one of St. Petersburgs many fine restaurants.
Oncology studies
A Russian pharmaceutical company has chosen us as a full-service CRO for a chain of oncology studies.
1 september 2006
RCT expands Quality Assurance group
Due to our growth, and in keeping with customer expectations for our continued high quality of work; RCT Global announces a new addition to our Quality Assurance team. We are proud to announce that Dr. Vladimir Bokovanov has accepted the position of Quality Assurance Manager, overseeing the QA department. Dr. Bokovanov has been instrumental in the success of RCT as both a CRA and Project Manager. In addition to his clinical expertise he was also responsible for creating and updating many of our current SOPs. His excellent work ethic and knowledge of Good Clinical Practices makes him a superb candidate for this position.
Our Quality Assurance department is responsible for development and/or updating of SOPs, Best Practice documents, and operating guidelines; auditing of internal processes, vendors/suppliers audits, maintaining of GCP, clinical site audits, and FDA/Sponsor audit preparation.
23 september 2006
Early completion of enrollment
RCT Global is proud to announce the early completion of enrollment for a trial in patients suffering from CINV. In this trial RCT Global completed 88 patients in 4 months, exceeding expectations by 2 months.
26 august 2006
Breast Cancer trials
In addition to our ongoing trials RCT Global was also recently awarded two trials in Breast Cancer from two different Sponsors. The first trial involves 50 patients at 5 centers and the 2nd trial requires 80 patients to be enrolled at 2 centers.
20 august 2006
42nd Annual DIA Meeting
RCT Global participated in the 42nd Annual DIA Meeting held June 18 22 in Philadelphia, Pennsylvania, USA. DIA is an international organization that has meetings throughout the year to promote Drug Development education and awareness. Each year they have an annual meeting which draws thousands of research scientists from around the world. This year, as in recent years, there has been a strong emphasis on Regulatory and Global Regulatory issues associated with the growing international development of clinical research. Though the focus of the meeting may be strongly placed in the regulatory area they also offered educational tracks on operations, project management and the expansion of clinical research into new and exciting areas of the world. There were many companies from Russia and Eastern Europe that not only attended but exhibited as well promoting the benefits of the region and the growing expertise that continues to build in this area of the world.
Attending meetings like these and participating in the discussions and exhibiting keeps RCT Global abreast of the changing needs of our industry and how best to meet the needs of our clients.
27 june 2006
Specimen collection trial
RCT Global received MOHSD approval to begin support of an international specimen collection trial focusing on women's health.
26 june 2006
phase II Acute Viral Rhinitis
RCT Global was awarded an international phase II Acute Viral Rhinitis study which will enroll 30 patients in 2 Moscow based centers.
20 june 2006
phase III CINV
RCT Global received approval from the MOHSD to perform a large phase III CINV trial. The project will require 12 sites to enroll 132 patients in sites across Russia.
14 june 2006
Surgical Pain
Sponsor approval received to move forward with the planned phase II Surgical Pain trial. This trial will recruit 70 patients at 4 centers located in both St. Petersburg and Moscow.
5 june 2006
Gastroenterology trial approved
RCT Global received approval from the MOHSD to perform a large Gastroenterology trial enrolling 450 patients in 20 sites across Russia. This will be the 2nd such large trial for this indication within the last 18 months that RCT Global will monitor and manage.
30 may 2006
Ophthalmology study
RCT Global was awarded an international Pan-European ophthalmology program with sites in Bulgaria, Romania, Poland and the Czech Republic. This 8 site trial marks the 4th ophthalmology trial awarded to RCT Global over the last 2 years.
16 may 2006
Certification
Bulgarian office is now officially certified by the Bulgarian government to perform clinical trials. The opening the new modern office facility expands on our ability to provide in country service to both our current and prospective clients.
In this way RCT Global can take advantage of the high enrollment rates offered by the specialized institutions and the large pool of experienced investigators. Located in Sofia, our office provides a convenient location to meet with investigators or perform study planning in preparation for a new program. We are happy to welcome this office into our growing and successful family.
1 may 2006
Annual Partnerships Meeting
RCT-Global recently attended the Partnerships for Clinical Trials conference held in Las Vegas Nevada in the US. The conference addressed many of the challenges of outsourcing services to support clinical trials through lectures and workshops. This annual meeting attracts hundreds of participants across the world interested in learning how best to maximize their resources and bring their product to market sooner.
We have participated as an exhibitor and an attendee in order to promote our services in Russia, and Eastern Europe and better understand the needs of our clients. We want to thank all those who stopped by our booth to learn about our company and congratulate all those who won any of the numerous prizes offered through our daily raffle. Thank you for your continued support!
9 march 2006
18th Annual DIA EuroMeeting
RCT Global representatives participated in this Pan-European meeting held in Paris at the end of March. The programme was devoted to Pharmaceutical Legislation in Europe, Clinical Research processes, Project Management and Data management challenges in Pharmaceutical Development. The key speakers and presenters represented the leaders of the industry, and experts from regulatory bodies and academia.
9 march 2006
New style
We have adopted a new corporate style. It is reflecting our continued effort to improve the services for our Clients in a friendly and more recognizable manner. New style will appear in all RCT Global materials, printed and electronical.
The website is upgraded too, providing a more accessible and enjoyable browsing experience.
23 february 2006
2005
Storage facility
Having established our private storage facility, we now can offer storage of study medications in accordance to strict international and Russian local requirements under control of professional staff.
23 october 2005
Bulgaria
RCT Global has expanded operations into Bulgaria, providing the capability to offer regulatory and clinical support to our clients interested in running trials there.
21 september 2005
Enrollment record
RCT Global is proud to announce the completion of a large multi-center gastroenterology trial for a United States based pharmaceutical company. Given 9 months to randomize 456 patients the trial was fully enrolled in 4 months.
Due to the rapid rate of enrollment our Client concluded the trial 5 months earlier than planned.
06 may 2005
2004
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