News archive

2009

Oncology study in Ukraine

In an expansion of our Oncology therapeutic expertise, we announce the successful start up of enrollment for a Metastatic Breast Cancer project. This project is part of a global program for a US based biotech organization involving 8 sites in Ukraine. GCT became involved in this project late to supplement the enrollment for their ongoing global project. GCT was awarded the project based on our value to the client, who wanted to take advantage of our expertise in Oncology as well as our knowledge of the region and our access to high quality Investigators.

January, 2009; Kiev, Ukraine

2008

FDA audit

During the month of December, Global Clinical Trials' Russian office and several high enrolling sites completed a successful audit by the United States FDA. This audit was performed to review a metabolics program for one of our U.S. based clients in association with their U.S. submission of the study medication.

December, 2008; St. Petersburg, Russia

Global Clinical Trials makes management changes

GCT is pleased to announce key changes in the Management of their Russian operations. Kirill Zhuravlev, M. D., Ph. D. has been appointed General Director, responsible for the operations and management of GCT’s largest operational office. Dr. Zhuravlev comes to GCT with many years of Industry experience working for both CROs and major Pharmaceutical companies. In his last position, prior to joining GCT, Dr. Zhuravlev was General Manager of OCT Group, an International CRO.

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

In order to meet the needs of our clients and address growing business requirements, GCT has expanded and upgraded it's Drug Storage facility located in St. Petersburg, Russia.

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 (-5°C—+10°C), an expanded room temperature storage area, a gate chamber to receive and ship product on Pallets, and expanded freezer space (-70°C) with a self contained back up generator, all carefully monitored and maintained.

”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 women’s 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

GCT was awarded a new International Ulcerative Colitis Trial. This trial, which will run in both Russia and the Ukraine, requires 250 randomized patients suffering from moderately active ulcerative colitis. Based on the protocol requirements and study time lines GCT will perform and manage this trial in 35 sites across both countries. Global Clinical Trials has performed many similar trials and has a very experienced team in place to set up and run this project from beginning to end. GCT is pleased to be able to bring the synergies of our capabilities and the recruitment benefits of both Russia and the Ukraine to our new client. The project has some challenging time lines, however based on out team's knowledge of the therapeutic area and relationships with the sites GCT is confident we will meet or exceed their expectations; providing a very successful experience in working within the region. We are excited to have the opportunity to expand our experience in this very familiar therapeutic area, but more excited to be introducing this region of the world to a new client whom we look forward to working with long into the future.

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. GCT’s 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 Women’s 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 Alzheimer’s 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 15^th World Congress of the World Association for Dynamic Psychiatry, May 14-18, and the 13^th 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 it’s 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

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